Articles

New Dietary Ingredient (NDI) rules planned for the supplement industry

A rumble of discontent is being heard across the dietary supplement industry since a draft guidance document was published last month by the US Food and Drug Administration. In response to the FDA Food Safety Modernization Act signed into law in January by President Obama, the FDA was required to produce a documents requiring dietary supplement and foods companies to submit safety information on any new dietary ingredient (NDI) placed into products after 1994.

The guidance document is open for comments from industry but, when issued, a final rule will require dietary supplement products to file a claim of a New Dietary Ingredient (NDI) for any supplement component that was not part of the diet before 1994. What seems to be riling up the industry is that any change in supplement composition after 1994 will require filing of a NDI disclosure. That is, if you as a manufacturer add more DHA to your fish oil supplement, you have to file a NDI notification.

Stepping back, the goal of the FSMA makes perfect sense: it shifts regulators attention from responding to food contamination issues to preventing them. And because the Dietary Supplement Health and Education Act of 1994 (DSHEA) treats herbal and non-botanical dietary supplements as foods and not drugs, the supplement industry has largely been immune to requirements of prospective demonstration of safety and efficacy. Perhaps the greatest change has been that manufacturing standards have improved greatly since FDA issued a final rule in 2007 on Good Manufacturing Practices for dietary supplements.

But to be sure, the FDA draft guidance on New Dietary Ingredients is a bit complicated. The draft guidance indicates that FDA doesn’t have a reference list of dietary ingredients that could be grandfathered in (i.e., sold before 1994). Instead, companies are required to provide that information. And the NDI notification process is complex, leading to at least one consulting company with NDI experience offering its services. While prospective safety testing is not required, the NDI process requires a reasonable calculation of safety based upon known LD50 values for dietary components in non-human species relative to the intended human dose.

The guidance indicates that FDA will even require companies to produce NDI documentation even if their solvent extraction processes have changed for a product intended to contain the same dietary ingredients.

Regular reader Jeff Engel dropped me a note with links to a spectrum of reactions from dietary supplement advocates. Most have the same type of objections from back in the early 1990s when FDA Commissioner David Kessler indicated that soem regulation was going to be placed on the supplement industry, efforts that led to the rather watered-down DSHEA legislation.

For example, Byron Richards spends most of his screed arguing that the FDA is putting in these regulations because of the influence of Big Pharma. There, the straw man is out in force, with much of the article citing challenges in the drug industry as driving FDA to kill the dietary supplement industry.

The FDA Law Blog (not an FDA site) made the interesting observation that FDA measures to regulate the dietary supplement industry have come in two 17-to-18-year cycles.

The Life Extension Foundation goes even further calling the draft guidance, “FDA’s Latest Attempt to Ban Your Dietary Supplements”:

It appears that the FDA is claiming that dietary supplements are unsafe, and in order to “protect consumers” the agency must place a stranglehold on the dietary supplement industry by requesting exorbitant safety testing. These ludicrous safety thresholds are in excess of those required by pharmaceutical drugs despite studies showing supplements are far safer than drugs. [The emphases are theirs - DJK]

I hate to tell the LEF folks this but drug companies have themselves been saddled with terrific troubles in having to demonstrate that long-marketed drugs are actually approved products. The Unapproved Drugs initiative revealed that many formulations of recognizable drugs (codeine, ergotamine, nitroglycerin) were never formally approved as drugs. In the last two years, FDA has fined companies for $20 million to more than $300 million dollars for selling “old” drugs without providing evidence that they were actually approved. One of the best known of these drugs is the expectorant, guaifenesin. The fact that big companies were opened the door for then-small company Reckitt Bensicker to gain over-the-counter approval for the drug and the highly successful launch of Mucinex products. Mucinex has benefitted further by FDA’s subsequent action against companies selling timed-release versions of guaifenesin – again, the Mucinex products are the only ones thus far with FDA approval.

My view is that the FDA is consistently applying rules across the industries and that the dietary supplement industry is still treated far, far less stringently. Remember, dietary supplement companies do not have to demonstrate effectiveness of their products. Yet they are still marketed with thinly-veiled claims for “effectiveness.”

NutraIngredients-USA.com has a good roundup on industry reactions. One of the more reasonable discussions includes an interview with Mark Blumenthal, executive director of the non-profit American Botanical Council (ABC), an organization that actively cultivates input from top academic pharmacognosy experts. Blumenthal makes a very good point on whether a biochemical supplement extracted from a plant vs. made by fermentation is truly different – what about synthetic vitamin C?

“ABC is willing to concede, in principle, that synthetic ingredients might be considered NDIs ipso facto. However, we add one reservation: Chemical synthesis makes a ‘synthetic’ material, per se. However, a process like fermentation creates an ingredient via biosynthesis, and this is the source of numerous dietary ingredients.

“While ABC prefers to focus on natural plant materials, plant extracts, and plant-derived compounds, we are aware that some plant-based dietary ingredients are now produced – for the sake of cost and efficiency – via fermentation.

“L-theanine may be an example, where the resulting ingredient made via fermentation is claimed to be chemically identical and, presumably, biologically similar or identical in action to the L-theanine found in green tea leaves.”

For now, those objecting to the proposed FDA guidelines can submit their objections, as did Bill Sardi who posted his letter at his Knowledge of Health website.

By the end of reading through all of the confusing information necessary to put together this post, I’ve come to at least one conclusion: I doubt very much that these rules will affect what I’ve seen as the greatest threat to public health with dietary supplements: the adulteration of supplement products with prescription drugs.

What do you think?

Posted in: Herbs & Supplements, Legal

Leave a Comment (78) ↓

78 thoughts on “New Dietary Ingredient (NDI) rules planned for the supplement industry

  1. Jeff says:

    To me the FDA’s new NDI Draft Guidance seems disingenuous. One example can be seen in the way it treats synthetic botanicals. The document states,

    A synthetic copy of a constituent of a botanical was never part of the botanical and thus cannot be a ‘constituent’ of a botanical that qualifies as a dietary ingredient. Similarly, a synthetic version of a botanical extract is not an ‘extract’ of a botanical…because it was not actually extracted from the botanical.

    The Federal Food, Drug, and Cosmetic Act makes it clear both natural and synthetic versions of food ingredients can be included in supplements.

    The FDA is now saying, for the first time, that a synthetic, molecule-identical version of a botanical extract is not a dietary ingredient, and therefore can’t be sold as a dietary supplement. Why is the agency doing this? Is it because hundreds of people have reported serious side-effects from taking them? Of course not, although the FDA always claims to be acting on behalf of consumer safety. It seems clear the agency wants to hand over this entire field of potentially lucrative research and development to drug companies. The resulting products can then be patented, and priced multiple times higher than their non-patented supplement counterparts. David links to Byron Richard’s article, “The FDA’s Scheme to Reclassify Nutrients as Drugs”, which explains this issue very well.

    What is not clear is whether the FDA aims to go after all synthetically produced supplements; this currently includes, for example, most supplemental vitamin C, B1, B2, B3, etc..

  2. Scott says:

    I also don’t get the distinction between manufacturing processes if the end product is the same. Or is the requirement to demonstrate said end product actually IS the same (as opposed to, say, containing some potentially dangerous reagents used in the synthesis)?

    That said, I always find it hilarious when supplement hawkers flip out over being asked to provide some limited evidence for a small subset of their marketing claims. Hello? If they don’t have that evidence in the first place, then they’re lying by making those marketing claims.

  3. Angora Rabbit says:

    I received the notice about this last week (I’m on the ILSI list) and wondered if you folks would pick this up – am very glad you have!

    As a nutritional academic I’m delighted at how far the proposed regulations have gone, although I am not optimistic that they will remain so and will be likely watered down by an industry that puts profits ahead of safety and efficacy.

    A context may be helpful here – consider the L-tryptophan disaster several years ago. The manufacturer changed the process and ended with a contaminant that caused either eosinophilia or nerve damage (sorry file is at work and I’m writing from home). The comments by ABC are disingenuous – they should know darn well that processing changes can cause enormous product problems. Filings as proposed by FDA are simply GMP – Good Manufacturing Process, as Dr. Kroll rightly points out. For shame on protesting otherwise.

    Regarding vitamins etc, I believe there was a GRAS exemption but I can’t confirm that because, drat again, the file is elsewhere and I’m prepping for a short holiday! Maybe I can dig it out of my outbox…

  4. JPZ says:

    @Jeff and Scott

    I thought the guidance was that synthetic forms of botanical extract components cannot avoid a NDI by claiming to be part of a pre-1994 botanical product. Which makes sense to me. The synthetic form of lycopene contained a lycopene-c25-aldehyde, not found in nature, that had a potentially teratogenic breakdown product (http://ec.europa.eu/food/fs/sc/scf/out47_en.pdf). Chemical synthesis can have a lot of weird isomers show up, and fermentation synthesis can have a lot of weird contaminants show up (extensive purification tends to be cost prohibitive – think Sigma catalog prices). So, shifting the onus onto the manufacturer to prove the synthetic and natural versions are identical seems common sense.

    Also, botanical extracts tend to be highly complex mixtures, and synthetic forms attempt to reproduce one component – not the whole DSHEA-approved mixture. If the synthetic form reproduces a component previously purified and approved, then the botanical extract provision doesn’t apply.

  5. nybgrus says:

    @everyone but jeff: I was thinking something along those lines – thanks for clarifying. I knew there was something wrong with Jeff’s post, but you saved me the time and research to figure it out.

    @Kroll:

    American Botanical Council (ABC), an organization that actively cultivates input from top academic pharmacognosy experts

    I see what you did there ;-)

    Thanks for the article. I am happy to see more restrictions and controls in the supplement industry. Everyone who decries these sorts of things do so by saying it is “stifling” the industry or “imposing undue restrictions.” I agree – I just think the restrictions are very reasonable and some stifling of that industry would be a good thing.

  6. Jeff says:

    @Nybgrus says,

    “I knew there was something wrong with Jeff’s post, but you saved me the time and research to figure it out.”

    Please be specific. What exactly was wrong with my post? Why do you think the supplement industry should be “stifled”? Can you provide any hard data showing supplements are actually harming people? Daniel Fabricant, who heads the FDA’s dietary supplement division says we need these burdensome new regs for the sake of “public health”. Yet neither he nor the FDA can provide any data showing supplements are a threat to anyone’s health. The FDA’s website has several pages of adverse event data concerning drugs. According to the FDA:

    1. 471,291 serious drug adverse events reports were received for the year 2010
    2. 82,724 deaths were caused by drugs in 2010.

    The FDA doesn’t post any numbers for supplement AERs. Presumably the numbers are too low to bother with.

    If I search the web for data about supplement AERs, all I can come up with are studies like this one:

    http://www.ncbi.nlm.nih.gov/pubmed/18570167

    Supplements are the cause of few adverse events and virtually no deaths.

    With such a huge disparity between the safety profiles of supplements and drugs, why do you think they should be regulated the same way?

    As David points out, there is a problem with illegal supplements – those spiked with drugs. But this is a result of lax enforcement of current laws.

  7. nybgrus says:

    Jeff:

    The evidence is in the hundreds of posts on the topic here. I’m not about to rehash the whole thing because you are trying to claim that ADR’s with prescription drugs exist. Even if the ADRs from supplements were 1/100th that of prescription drugs (which it isn’t) that still would not be an argument for the regulation of the industry to be more lax.

    Even if supplements were 100% safe and there were ZERO ADRs that still wouldn’t be an argument for less regulation. They are marketed as doing something for which there is no evidence. That alone is reason to make sure that what is marketed is at least safe and potentially has some worth.

    The argument you are making is, in essence:

    1) Researched pharmaceuticals have negative effects
    2) Supplements have fewer negative effects
    3) Therefore we can be lazy about supplement regulation

    Sorry Jeff, but that is just bad reasoning.

  8. Jeff says:

    nybgrus says, “They are marketed as doing something for which there is no evidence.”

    I recommend you go to the FDA’s website and read this page:

    Claims That Can Be Made for Conventional Foods and Dietary Supplements

    There are quite strict rules about what claims are allowed. When a rogue company makes false or outrageous claims the FDA will take enforcement action:

    http://www.fda.gov/ICECI/CriminalInvestigations/ucm234904.htm

    1994′s DSHEA was fairly successful at striking a balance between consumer access and appropriate regulation for a very safe class of products. The new NDI Draft Guidance clearly contadicts Congressional Intent (as expressed in DSHEA). It will be interesting to see how consumers react to a few power-hungry bureaucrats as they try to dismantle an entire industry.

  9. JPZ says:

    @nybgrus

    MOST of the new NDI requirements are very reasonable, and I welcome their guidance. But, there are some unreasonable parts of the guidance. If I mix new and unusual (e.g. acai) ingredients together to make a muffin, then that is OK. But, if I mix ingredients together that are approved and safe at the amounts I use, and put them in a dietary supplement, I have to go though a whole new regulatory approval process to use something full of approved and safe ingredients. That isn’t fair.

  10. JPZ says:

    @Jeff

    You pretty much quoted Marc Ullman there (“Congressional Intent”), so I assume you are in the Industry (and I like Marc’s insight BTW). Care to fess up whom you are shilling for?

    DSHEA grandfathered in anything on sale before 10/15/94. How does that make them safe (note to docs here, the same thing occured in 1936 for drugs)? You can’t compare SAEs from supplements and drugs. Drugs go through clinical trials where SAEs are recorded and reported to physicians to determine if the SAE is replicated in the population. Dietary supplements are assumed safe, and only recently has there been a reporting system for AEs. Because dietary supplements are not subject to premarket testing, physicians have no idea what SAEs or AEs to expect. The hope is that physicians can detect dietary supplement AEs and report them with sufficient frequency to trigger concerns. Some of us are pushing for more safety testing in our industry, please don’t discredit us with rhetoric.

  11. nybgrus says:

    JPZ:

    Perhaps there are some parts that are unfair. I have not read the whole thing and dissected it, but I do trust your assertion on that point. However, I think that I would rather err on the side of caution and being slightly overrestrictive than under.

    I understand your point about the acai berry muffin. However, selling a muffin is inherently different than selling a dietary supplement, even if it is the exact same thing. I think this harkens back to our previous discussions on intent. If I make a muffin and tell you it is tasty and low fat, then I really don’t need to much oversight. If I sell you the exact same muffin and say it will supplement some needed nutrient and help you “be more healthy” then I think you are making a fundamentally different claim and should be held to that regulatory approval process.

    In the case of the muffin, it really isn’t fair, I agree. But we see the slippery slope that happens when things like the DSHEA come in and allow for that “fairness.” I mean, how on earth does it make sense that DHEA is a “natural and safe supplement” that can be bought over the counter? I know we tend to agree on most things and it is the fuzzy middle where you and I tend to respectfully differ in opinion.

    My point is that the model you seem to espouse requires intellectual honesty. If that were present in ample supply I think I would agree with you around 99%. But it isn’t and so we must regulate and legislate with that in mind. Plus, I really don’t see a problem with the supplement/natural botanical/nutraceutical/macro-blah blah industry taking a hit. Nobody (except those who stand to profit monetarily) would be the worse off for it, some would be much better off, some a little better off, and overall a huge chunk of money could go somewhere better.

    I think a lot of this gets down to some argument of “consumer choice.” The general mentality is that it is always better to have a Chinese menu of everything available at all times and let the consumer decide. Otherwise the only other option presented is usually one of overbearing paternalism. I think that is a false dichotomy and that having a system in place where there are fewer but more effective and evidenced choices is much better. If that means stifling some nutraceutical business then so be it – the money that would have gone to support it can go to better places. If that means that some amazing natural product with actual efficacy goes unnoticed for years longer than it otherwise may have – so be it, such is the nature of science. The odds of that happening are miniscule compared to the odds of useless and/or deleterious garbage being marketed instead.

    But, I am quite happy to have informed individuals such as yourself advocate for making the regulations better, more reasonable, ethical, and within the evidence base. Since I am not quite as informed on that specific topic though, my stance is one of “better too much regulation than not enough” since I have seen what “not enough” leads to.

  12. Jeff says:

    Do I have to be a shill just because I want to keep my supplements? Only twice have supplement adverse events been a real concern:

    In the 1980s a tainted batch of L-tryptophan caused some deaths. Then there were the problems caused by Ephedra in the 1990s. In both cases problems were recognized quickly by the medical profession and the FDA, and both substances were banned. It seems to me these two exceptions prove the rule that the vast majority of supplements are safe, and AERs are few and far between.

    As an example of how supplement safety is determined, there’s this recent animal studywhich found that grape seed polyphenols might be effective at preventing Alzheimers’. One researcher stated,

    Since naturally occurring polyphenols are also generally commercially available as nutritional supplements and have negligible adverse events even after prolonged periods of treatment, this new finding holds significant promise as a preventive method or treatment, and is being tested in translational studies in Alzheimer’s disease patients.

    Supplements are presumed to be safe because most have been around for many years and have a long history of safe use. Polyphenols have been part of our diet for thousands of years and the human body knows exactly how to metabolize them.

  13. nybgrus says:

    DHEA has a long history of safe use? Red yeast rice? Glucosamine? Vital greens enzyme rich super food? Bowel Biotics? Yeah, long standing history of safe use there Jeff. How about Fen-phen?

    And just because the body “knows how to metabolize them” don’t mean diddly. The body knows how to metabolize acetaminophen and carbon tetrachloride too.

  14. JPZ says:

    @nybgrus

    As always, you make a great point. My point about the muffin is that if I want to make a new muffin, no one cares and I can do what I want – which makes sense if all the ingredients are safe and approved by the FDA (ignoring bloody melatonin nonsense). If I want to make a slight variation on an approved dietary supplement with safe and approved ingredients, I have to go through a long and expensive process for each minor change in formulation. Yes, it isn’t fair but I am advocating for engagement with the FDA to find a best-practices middle ground. As I have always said to my labs, “Data Wins.”

    Nice comment “Intellectual Honesty.” This is why I think stronger regulation is needed. The responsible companies will benefit when the irresponsible companies are weeded out.

  15. JPZ says:

    @Jeff

    Really? I thought I had laid out the case that supplement safety is suspect especially if you want to compare it to drug safety. L-tryptophan was a processing error, which the new NDI proposal would try to correct. History of use makes a dietary supplement a lead, not safe or effective. Pharmaceutical companies have 2500:1 chance of turning a lead into a candidate. Nutritional compounds are 5:1 in my experience.

    So, seriously. Whom are you shilling for right now? I know the rhetoric (perhaps more than anyone here). Are you an unusually well-informed MLM player? Nothing wrong with being a believer, but you just need to fess up.

  16. nybgrus says:

    @JPZ:

    Thank you for the kind words. I do enjoy our discussions for exactly that reason – you make very good points as well and are quite reasoned.

    As for your discussion with Jeff… I also find that very interesting. I can tell quite plainly he is not your “average Joe” CAM/nutraceutical lover. There is definitely something more there. But I can’t pinpoint it further than that. I reckon for you it is like when I read some medical anthropologist writing – I can smell that a mile away. I’m very curious to see how it pans out with Jeff – especially considering he has wound his way over here from Respectful Insolence.

  17. Jeff says:

    Dr. David Gorski, the managing editor of SBM uses this phrase from time to time, “the pharma shill gambit”: This applies to those who believe that anyone who has anything good to say about drugs or the pharmaceutical industry must be a paid shill.
    I guess JPZ is an example of someone using the “supplement shill gambit”.

    I’ve been taking supplements daily since 1972. Currently I take quite a few supplements, some in fairly high doses. I believe this, plus diet and exercise, explains my good health all these years. I don’t want the FDA taking away natural health options from me or any other American consumer.

  18. JPZ says:

    @Jeff

    I’ve been in the nutritional product industry for 15 years. The only “shill gambit” here is the pot calling the kettle black. Ultimately, we all get judged on our science and how we interpret it (mostly). ;)

  19. nybgrus says:

    @JPZ:

    I wrote a small blurb last night that got hung up in moderation for some reason.

    Sadly, I will not be participating much on these forums for the next week. I have family arriving in town today so between some travel and entertainment and my regular studies I likely won’t have time. I’ll leave Jeff to the rest of the extremely capable commentariat here :-)

    @Jeff:

    Trust me Jeff, we would not be taking away anything of value from you. When you have more disposable income and no change in your health status, you’ll thank us ;-)

  20. Jann Bellamy says:

    @ Jeff:
    “I’ve been taking supplements daily since 1972. Currently I take quite a few supplements, some in fairly high doses. I believe this, plus diet and exercise, explains my good health all these years.”

    I haven’t been taking supplements since 1972. I believe this, plus diet and exercise, explains my good health all these years.

  21. zed says:

    Damn, Jann, You stole my comment idea! Although I can’t say I’ve been doing anything since 1972, mainly because I was born in 1973!

  22. Zetetic says:

    One wonders if “Jeff” would be willing to do a blinded study where he wouldn’t know if he’s taking his dozens of daily supplements or not. Would he feel any different?

  23. Angora Rabbit says:

    @Jeff,
    The FDA doesn’t post any numbers for supplement AERs. Presumably the numbers are too low to bother with.
    Supplements are the cause of few adverse events and virtually no deaths. ”

    It’s because the makers aren’t required to report adverse consequences. That is a far, far cry from no adverse effect.

    Btw, one of the leading, maybe the leading, cause of child poisoning is the mother’s iron supplements. Yup. Good ol’ One-A-Day. And vitamins and minerals are natural and safe, right?

  24. ConspicuousCarl says:

    Jeff Said:
    With such a huge disparity between the safety profiles of supplements and drugs, why do you think they should be regulated the same way?

    Just because most “supplements” are generally safer than what you like to call “drugs” does not mean that all supplements should be assumed to be safe without testing.

    By the way, “supplements” also do not require efficacy testing and the supplement market is therefore flooded with inert nonsense. That takes down the average risk. Easy to make safe screwdrivers out of rubber, isn’t it? But even in a pile of 100 rubber screwdrivers, that steel axe is still dangerous.

  25. WilliamLawrenceUtridge says:

    Perhaps there are some parts that are unfair. I have not read the whole thing and dissected it, but I do trust your assertion on that point. However, I think that I would rather err on the side of caution and being slightly overrestrictive than under.

    Particularly given the harms of vitamin overdoses are known to occur, both chronically and acutely, but the benefits (beyond frank deficiency) have never been conclusively proven.

    Jeff, do you also exercise? Eat moderate amounts of processed foods? Strive to relax and live a life low in stress? Live in a middle-to-high-income neighbourhood? Regularly visit your doctor? Have a high level of education? Have actual liesure time? Enjoy(ed) your job? Have a spouse? Have friends you can see regularly? Have enough time to maintain a hobby or two?

    If you answered yes to even one of these questions, you’ve just muddied up your n=1 study.

    Also, other commentors please correct me if I’m wrong, but I would assume your body controls the levels of vitamins in your tissues and bloodstream. It excretes the water-soluble ones that you don’t need, and stores the fat-soluble ones to be extracted when needed. Depending on the dosage, you wouldn’t necessarily see acute effects unless you pull a Gary Null (wow, that is one effin’ creepy picture) and take a massive acute OD, or saturate your fat tissues.

  26. Jeff says:

    @Angora Rabbit:

    On December 22, 2006, President Bush signed the Dietary Supplement and Nonprescription Drug Consumer Protection Act into law. This law put in place a system of mandatory reporting of serious adverse events for dietary supplements. In 2009 The FDA issued a requirement that all supplement packaging carry contact info so consumers could report any problems.

    Why doesn’t the FDA make these numbers public in the same way the agency does for drug AERs? It would help consumers to know if there were any problems with a particular supplement or supplement company. Could it be that the numbers are too low to generate the kind of fear and distrust the FDA wants consumers to have reagarding dietary supplements?

  27. JPZ says:

    @Angora Rabbit

    Manufacturers are required to report supplement AEs and SAEs (http://www.fda.gov/food/guidancecomplianceregulatoryinformation/guidancedocuments/dietarysupplements/ucm171383.htm).

    @Jeff

    There is a difference between knowing what to look for and waiting for something unexpected to happen. Pre-market drug safety testing produces a list of AEs and SAEs for physicians to monitor, diagnose and report to the FDA from the first day the patient starts on the drug.

    The FDA does not have the statutory authority to require pre-market safety testing of grandfathered dietary supplements. So, post-market surveillance is a repeated n=1 study. That leaves physicians guessing about associations between supplements and AE/SAEs, and the direct reporting by consumers adds a lot of noise to the system, e.g. “I started taking St. John’s wort and now my cat won’t sit on my lap.”

    Thus, drug AE/SAE reports involve counting the incidence of known problems, and dietary supplement AE/SAE reports hope to detect unknown problems amid a sea of noise. Apples and oranges.

  28. Jeff says:

    @JPZ:

    When genuine problems occur, as they did with L-Trytophan and Ephedra, doctors pick up on them quickly. The relatively low number of supplement AERs can be explained, not by doctors’ ignorance, but by the fact that so few problems exist. Supplements have been around a long time, and truly harmful side-effects would have been recognized and made public by the FDA. Supplement-drug interactions, for example, have been the subject of much study, as in the book,

    Herb, Nutrient, and Drug Interactions: Clinical Implications and Therapeutic Strategies
    Authors: Mitchell Bebel Stargrove, Jonathan Treasure, Dwight L. McKee
    This book is quite technical and was written for health practitioners. Check it out at Amazon.com.

    Making pre-market testing a requirement sounds good, but would it really make supplements safer than they already are? Or would it just make them substantially more expensive and hence unaffordable for most consumers? Some researchers believe far more Americans suffer health problems from nutrient deficiencies and insufficiencies than from supplement adverse events. Maybe public health officials should be looking for ways to encourage higher supplement use.

    A study funded by the Centers for Disease Control found that in 2005 84,000 Americans died from a lack of Omega-3 fatty acids in their diets.

    From the study:
    “The mortality-reducing effects of omega-3 fatty acids….have been confirmed in randomized trials.”

  29. Nate Dogg says:

    Making pre-market testing a requirement sounds good, but would it really make supplements safer than they already are?

    Yes, of course it would. Why would you even ask this question?

    From the study:
    “The mortality-reducing effects of omega-3 fatty acids….have been confirmed in randomized trials.”

    Does the phrase “cherry-picking” mean anything to you? Omega-3s are one of the few supplements that are generally recognized as possibly being worth a damn. That doesn’t mean that the vast majority of the others aren’t worthless crap (they are).

  30. I’m not entirely clear of the FDA’s threshold for making public the AERs of dietary supplements but be aware that they are treated like foods. Therefore, recalls and safety alerts on herbal products will be lumped in with foods as in this database:

    http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2011/pp_fda_gov_dynamic_list

  31. nybgrus says:

    Making pre-market testing a requirement sounds good, but would it really make supplements safer than they already are?

    To paraphrase: “Here is a giant collection of random and largely unknown things of various nature and etiology which we have assumed to be more or less safe. Would actually checking them to make sure they are safe actually improve the overall safety profile of this collection?”

    As Nate Dogg said: Duh.

  32. JPZ says:

    @Jeff

    The tryptophan and ephedra examples involved counting fatalities (as well as SAEs). When people are dying of an unclear cause, the data collection process improves greatly and the association between the cause and effect becomes more black and white (after all, time of death is fixed). Even then, ephedra took years and several court battles to ban.

    Premarin was largely pulled from the market because there were 6 more heart attacks annually per 10,000 women using the drug compared to placebo. For the medical community, 6 in 10,000 was an unacceptable excess risk for women treating hot flashes, etc.

    I don’t think we have to test supplements at the level to detect 6 in 10,000 SAEs (after all the WHI was HUGE), but I think some relatively modest changes in the system could improve SAE and AE detection enough to greatly reduce the risk of overt morbidity and mortality with dietary supplements. Who knows – maybe we will find them to be unusually safe. Right now, I don’t think we have enough data to say that.

  33. Jeff says:

    Here’s a news story about a new, industry-sponsored website meant to help consumers identify those products adulterated with drugs:

    http://www.nutraingredients-usa.com/Industry/New-website-to-keep-consumers-industry-up-to-date-on-tainted-products

  34. stanmrak says:

    Jeff, there’s no point in arguing with these guys… ever hear the saying, “Blinded by science?” It certainly applies here.

  35. Jeff says:

    I just discovered this opinion piece posted by The Washington Times on July 28:

    The Coming War On Vitamins: New FDA rules would diminish nutrient choices
    By Michelle Minton

    http://www.washingtontimes.com/news/2011/jul/28/the-coming-war-on-vitamins/#disqus_thread

    It certainly is refreshing to read a newspaper editorial opposing the unnecessary, over-regulation of dietary supplements.

  36. nybgrus says:

    Oh yes, so very refreshing to read another article using the “Oh noes! They are taking away our health freedoms” gambit.

    This exemption was deemed necessary to preserve the vibrancy and variety of the market for supplements. Because supplements generally cannot be patented, manufacturers would never see a return on the investment of proving scientifically what is already known about their safety and effectiveness.

    Perhaps we should make a similar such exemption for car manufacturers since Detroit has long been faltering and all these pesky “safety laws” are really just infringing on consumer choice to purchase a cheaper, albeit untested for safety, car? Or maybe an exemption for building engineers since the housing market is crashing and we can allow the builders to cut some corners to “preserve the vibrancy and variety” of houses available, including really cheap ones that are very poorly built?

    And before you jump all over me, Jeff, saying that the two are incomparable because supplements are “all natural” or “generally safe” with “low reports of side effects” I will once again call your attention to products such as DHEA or red rice yeast which contain active pharmaceutical agents and only exist on OTC shelves because of the insanely lax regulations.

    I would also point out that cars are indeed “generally safe” to drive in. Most people drive their entire lives without a serious accident and many manage to avoid even a fender bender. Considering there were 30,797 fatal car crashes in 2009 for a total of 2.979 trillion miles traveled, and 307 million people, that provides us with a death incidence of 0.01% death rate from car accidents and 3.35×10^-7 deaths per million miles traveled… or roughly 1 death per 10^8 miles traveled. Don’t you think that with such an amazing safety profiles for cars, we shouldn’t burden the vibrancy and diversity of the automobile markets with such stringent safety regulations?

    source

  37. JPZ says:

    @Jeff

    News reports aren’t data. Safety requires data.

    @stanmrak

    What would prefer to be blinded by? Also, I don’t think it is a saying. I think it comes from an 80′s song by Thomas Dolby, “She Blinded Me with Science.” :)

  38. Jeff says:

    @nybgrus:
    Why do you keep picking on DHEA? I thought it was a steroidal hormone produced at various locations in the human body. Unlike anabolic steroids, it does not increase lean body mass in randomized trials:

    http://www.ncbi.nlm.nih.gov/pubmed/10613429

    In 2007 The FDA took actions which resulted in several red yeast rice products being taken off the market. Currently it is illegal to sell RYR products which contain more than trace amounts of monacolin K (identical to Lovestatin). The FDA does not allow any RYR product to make a claim of lowering cholesterol.

    Insanely lax regulations. The phrase is hyperbolic and innacurate.

  39. nybgrus says:

    Everything I wrote was hyperbolic for effect, in case you hadn’t picked up on that.

    Why do I keep harping on DHEA? Because your tack of saying it is “produced at various locations in the human body” is disingenuous. Epinephrine is produced as well. So are endogenous cannabinoids. And opiates. Perhaps I should lobby to have marijuana available to preserve the “vibrancy and variety” of my pharmacy shelves since it also has a long standing history of safe usage and I can claim my endogenous cannabinoids need repleneshment… AND that I should be allowed to do so without the prescription or oversight of a physician.

    Why do you care about whether it builds lean muscle mass? It also doesn’t make you think you can dance well. What’s the point? The point is that it is an active molecule with potential for significant physiological interaction. A molecule whose USRDA is not established, low values are not understood, toxicity is not well defined, and basically – we just don’t friggin’ know! So having it be available just because we like to have our “vibrancy and variety” to sell whatever the hell we please is a ludicrous argument. The exact same one that should allow me to stock a pharmacy with heroin poppy extract and hashish.

    As for the RYR products…. you have just proven my point. The reason it “worked” was because it contained lovastatin. An actual drug that was in unregulated quantity and purity. The FDA finally stepped in and is attempting to block the sale of RYR with this compound. I say “attempting” because I bet I can have some RYR with monacolin K shipped to your door if you give me your address (hence my “insanely lax regulations” comment). So how can you possibly claim that the myriad other “supplements” and “natural products” that you so much want to not be regulated won’t have an actual pharmaceutical like lovastatin in it? How can you be sure of it when the law that might actually help identify such things is what you oppose? And even moreso, if your argument is that such things can be picked up in post marketing and removed, why not just prevent them from coming to market in the first place? I mean, you are advocating removing the very things that make these “supplements” work in the first place! This is no different from saying we should be able to hawk whatever gullible suckers will buy. Which is all well and good, but I fancy myself a little more ethical than that.

  40. JPZ says:

    @nybgrus

    OK, I am there with you on DHEA. Hormones are very pluripotent, and we should evalutate this potency when regulating dietary supplements.

    But, (and apologies for the “but”) I will conjecture that this line of argumentum leads to “if it works, it is a drug.” Which came first, lovastatin or red yeast rice (honestly, I don’t know). Functionality is not an excuse for dismissing bioactive components of the diet (IMHO).

  41. nybgrus says:

    No apologies necessary JPZ – you and I are pretty much on the same page. I just take a harder nose to it than you and cut my edge closer to the “better safe than sorry through more regulation” side of things is all.

  42. Jeff says:

    @nybgrus:

    Comparing DHEA to heroin seems a bit of a stretch.

    It is becoming apparent how extreme your position is: If a supplement is bioactive – if it has any physiological effect on the body – consumers should not have access to it, no matter how strong a safety record it has. (Of course all supplements, including vitamin C, have some effect on human metabolism.) You think American consumers are simply too dumb and ignorant to make rational, independant decisions regarding their own health. And even though neither you nor the FDA can provide any hard data showing supplements are harming people, you think all supplements should be banned and put under the complete control of doctors and FDA bureaucrats. And what a coincidence – you yourself are studying to become a doctor!

    Incidentally many foods are bioactive and affect human metabolism. If human trials prove that grape seed polyphenols can prevent Alzheimers’, should we then have to get a prescription from a neurologist if we want to consume grape seeds or grape seed polyphenols?

  43. nybgrus says:

    I am “extreme” in that I value safety, knowledge, and evidence… which stems from the fact that I am training to become a doctor and not a “Big Suppla” shill.

    consumers should not have access to it, no matter how strong a safety record it has.

    No. You don’t have any record of how strong the safety is. Vitamin C has a strong safety record, good data in studies, a USRDA, etc. I am fine with that being over the counter – but marketed properly (i.e. it doesn’t really do much of anything unless you have scurvy). Stuff like DHEA, feverfew, black cohosh, or TrinFinity8, etc I am not fine with because they have no actual established record of safety. All we know is that they don’t actually kill people like arsenic. Fen-phen was released and actually DID kill people and destroy their hearts yet it went through because there is no oversight and the moment someone labels it a “natural supplement” it can go through and be marketed for anything (as long as the quack miranda warning is on the bottle). Things like DHEA, RYR, St John’s Wort, etc actually do have active compounds that we know of and it is insane they should be marketed to treat actual diseases without any oversight or regulation as to dosing. And all of these have little oversight about quality of manufacture or exactly what goes in them because it is all “natural.” So when you buy gingko pills you find that for 20 different brands you have 20 completely different compositions and compounds actually in the pills.

    You think American consumers are simply too dumb and ignorant to make rational, independant decisions regarding their own health.

    No, I think that there is no bloody data for anyone to make rational decisions about these “supplements.” How can you even pretend to make that argument when there is simply no data to make an evaluation from? Show me the data that supports TrinFinity8 that anyone, let alone the average consumer, can use to make a rational, independent decision.

    And if the average American could make such decisions, then why don’t we let every medication be OTC? Why can’t a person just go pick up a bottle of beta-blockers for their high blood pressure after they check it at the kiosk in CVS? Or why can’t someone just go buy a bottle of sertraline when they are feeling down?

    You make a nonsensical argument.

    And even though neither you nor the FDA can provide any hard data showing supplements are harming people

    Because there is no hard data on these products at all!. Can you provide me with any hard data that pouring dish soap on your tacos is bad for you? No? So it must be fine then right? Perhaps I can market it as the “new hot sauce” that will give you a colon cleanse and improve your health and make it out of vegetable fat so I can call it “all natural” and put it on pharmacy shelves.

    Incidentally many foods are bioactive and affect human metabolism. If human trials prove that grape seed polyphenols can prevent Alzheimers’, should we then have to get a prescription from a neurologist if we want to consume grape seeds or grape seed polyphenols?

    If you are concentrating the grape seed polyphenols into a pill form so you can take the equivalent of 10 kilos worth of grapes in a single tab, then damned skippy it should come from a neurologist.

    The difference between JPZ and myself is that we disagree on the finer points where things become fuzzy – that very real “gray zone” where food and drug meet.

    The difference between me and you, Jeff, is that you say, “There is no data to show it is bad. It isn’t killing people like flies. So we should be able to market it as safe and potentially effective.”

    I say, “There is no data to show it is bad or good. At least it isn’t killing people like flies. But, we should not market it since we don’t know if it is safe, we have no evidence it is effective, and with an extremely high level of certainty we can say it won’t be missed by the consumer if it isn’t on a shelf somewhere.”

    You are arguing from a freedom of capitalism standpoint rooted in a “we don’t have evidence it is bad, and that is the only thing I need to know” platform. I am arguing from a societally responsible and science based perspective where there is no need to market these things since, on the whole, they are definitely a waste of money and almost certainly do more harm than good.

  44. nybgrus says:

    figured I should add:

    Comparing DHEA to heroin seems a bit of a stretch.

    I am not comparing the two. I am comparing your argument for why DHEA should be OK to market OTC and applying it to heroin and marijuana. Of course the two are not equivalent, but your rationale for DHEA is equally applicable and that is exactly why it is wrong.

  45. Jeff says:

    Several times nybgrus has described Fen-Phen incorrectly as a dietary supplement. Fen-Phen was a combination of drugs available only by prescription:

    http://www.pph-net.org/fenphen-fen-phen-fen.htm

  46. nybgrus says:

    Jeff:

    Your link does not work.

    However, I stand completely corrected. For whatever reason I was under the misconception that it was an OTC supplement. Normally I look up every tidbit I am even remotely unsure of, but I am human still, so I am sorry for the lapse.

    I’ve only mentioned it as a marginal part of my argument to illustrate that even when something does actually cause severe injury it is difficult to pick up unless it kills you rather quickly. The point was not so much that it went through under DSHEA but more that post-marketing surveillance can (and does) still allow for significant harm to come to consumers.

    So accept my apology for the error, make the necessary change in any reference I’ve made to fen-phen, and then address the rest of the argument. Or even just remove any reference to fen-phen if you like, the thrust of my argument doesn’t change.

  47. DW says:

    Link works for me.

  48. Nybrgus ” I say “attempting” because I bet I can have some RYR with monacolin K shipped to your door if you give me your address (hence my “insanely lax regulations” comment).”

    Actually, I believe you can have oxycontin shipped to your door via online suppliers, at least, I know you could a few years ago, since that was the source for a friend (with substance abuse issues) last overdose.

    With online commerce regulation enforcement, it’s not always that it’s insanely lax, it’s also that it’s insanely hard.

    I don’t mean to take away from your overall point, nybrgus, but everyone is struggling with how the virtual world affects law enforcement, we can’t nescasarily use that as an example that the current supplement standards are broken.

  49. nybgrus says:

    michele:

    You make a fair point. I don’t know how tough it would be to get a narcotic in such a way (I’ve never tried), but I’ll take your word on it. Consider that statement retracted.

    I have no issue with you (or anyone) picking apart my arguments and points – except Jeff has done it to dodge the point of my argument and you have done it to refine it.

    But I must admit – I am not in my usual headspace and it is becoming obvious since I have had to retract a couple of my statements in rapid succession. I may take a break from commenting anywhere for some time. I have been trying to keep up my usual routine after some very bad family news but I don’t think that is working out particularly well….

  50. Scott says:

    An important problem with relying on market forces to evaluate the safety and effectiveness of supplements is that individual consumers cannot perform any such meaningful evaluation. Any N=1 result can’t account for confounders, so the individual consumer can’t know whether the benefits they perceived had anything to do with the supplement or not. Nor can they determine the risk of rare side effects.

    The only way to reliably obtain such information is large controlled studies. In other words,

    You think American consumers are simply too dumb and ignorant to make rational, independant decisions regarding their own health.

    American (or any) consumers indeed cannot make rational, independent decisions regarding their own health if no useful information on which to base those decisions is available. This has nothing to do with “dumb and ignorant.”

    So the obvious next question is, on whose shoulders should the burden of producing the evidence necessary to evaluate the products fall? There’s only two real options – taxpayers, or the businesses selling the products. It doesn’t make any sense to make taxpayers responsible for establishing the safety and efficacy of products so that a business can then sell them and make a profit. Those who stand to profit from the product should be the ones demonstrating it to be safe and effective.

    But they currently have no incentive to do so, because they can *claim* it’s safe and effective without any actual evidence to that effect, and sell it on that basis. I see no way to produce such an incentive other than regulations requiring pre-market demonstration of safety and efficacy.

    If anybody has a proposal for other approaches to produce such data, feel free to present it.

  51. DW says:

    Just as context for my remarks … I am very much on the side of more regulation for herbs, supplements et al.

    But it did strike me, when someone posted above (I can’t find it now), that in fact it is pretty darn easy to, in effect, “get drugs shipped to your door.” My GP will call in a prescription for antidepressants for me with almost no notice and without any sort of huge work-up or requiring blood work etc. Of course, I’ve been seeing her for years and she knows my history. But it’s not really all that difficult to establish such a relationship. It might not be quite “shipped overnight to the door,” but it isn’t really very difficult, either.

    I think there are race and class issues in this, too. I think I can in some sense “get the drugs I want” without a hassle because I am white and privileged. Serious pain relief is always just a phone call away. Does this play a role in CAM usage? And yet, as others have noted, many users of CAM are well to do financially. It’s an enormously complicated issue.

  52. JPZ says:

    @Jeff

    “You think American consumers are simply too dumb and ignorant to make rational, independant decisions regarding their own health.”

    In a 2011 Newsweek poll, about 1/3 of Americans can’t name the Vice President (http://www.thedailybeast.com/newsweek/2011/03/20/how-dumb-are-we.html). There are some dumb people. What I fear more is a Dunning-Krueger effect (http://en.wikipedia.org/wiki/Dunning%E2%80%93Kruger_effect), i.e. people don’t know what they don’t know. I have years of experience and a lot of specialized knowledge about dietary supplements. I can walk into a “natural foods” store and spot 15-20 products with false or illegal claims within 30 minutes. How does an average consumer avoid these bad products? I am all for more regulation of dietary supplements if it gets rid of bogus products and allows more consumer confidence in scientifically-proven products. That appears to be one point where nybgrus and I differ. He prefers that effective supplements become drugs, and I prefer supplements undergo safety and efficacy testing to be supplements. Both points of view are attempts to improve the health of consumers. Also, I believe nybgrus is Australian and may not be terribly invested in American consumer behavior. ;)

  53. JPZ says:

    @DW

    I haven’t seen any data on race and class in CAM usage – you raise an interesting point!

  54. Jeff says:

    @JPZ:

    I certainly believe you can never have too much science. More research into how supplements work only benefits the consumer. But the testing requirements in the FDA’s NDI Draft Guidance seems like overkill. The FDA is asking that each finished product (not just the raw material) undergo testing for toxicity and birth defects. In many cases these are products which have been on the market for years with no resulting problems or adverse events. The financial burden, especially for small and medium-sized companies will be substantial. It will involve much duplication of effort for many similar products, and the under-staffed FDA will be swamped with paperwok.

    Are you aware of any instance where a supplement has been suspected of causing birth defects?

  55. nybgrus – You are being to hard on yourself. Unless you had some special substance abuse training, there’s no reason you would have known about the availability of narcotics online in the U.S.

    I wish I could offer some help or support with your family concerns, being so distant, I can only say that my thoughts are with you and your family.

  56. nybgrus says:

    Also, I believe nybgrus is Australian and may not be terribly invested in American consumer behavior.

    I am actually American, doing 2 years of my schooling in Australia. I will be returning home at the end of this year and finishing out the rest of my education back home. So indeed, I am quite concerned about American consumer behavior.

    That appears to be one point where nybgrus and I differ. He prefers that effective supplements become drugs, and I prefer supplements undergo safety and efficacy testing to be supplements.

    It is a fine distinction betwixt us, I think. One I am willing to be convinced otherwise on in the right circumstances. I just haven’t seen any evidence yet that allowing OTC access for active drugs would be overall beneficial. And I am not just saying that about supplements – things like aspirin and acetominophen are actually very dangerous as well and really shouldn’t be sold OTC, IMO.

    At a minimum I’d like the safety and efficacy testing for all products. If they are “safe enough” (another discussion for which I don’t have a solid stance on yet) then I am fine with the supplement being OTC.

    The FDA is asking that each finished product (not just the raw material) undergo testing for toxicity and birth defects.

    Because the point is that the manufacturing process and exactly what is in each pill is different now. That needs to be standardized and the best way is to make sure the final product is being tested, not just a list of ingredients that can be mixed and matched willy nilly.

    Are you aware of any instance where a supplement has been suspected of causing birth defects?

    Once again the “we don’t have proof positive of teratogenicity, so that means there musn’t be any” line of argumentation. In the absence of data, the assumption should not be “it is safe.”

  57. nybgrus says:

    @michele:

    You are being to hard on yourself.

    I often am. I’m constantly daunted by how much I need to know and how a mistake can cost a life or a limb (so to speak). So for me, I try and walk that line of “just hard enough” so I don’t go nuts ;-)

    I wish I could offer some help or support with your family concerns, being so distant, I can only say that my thoughts are with you and your family.

    Thank you for the kind words. It is very odd. I have dealt with death of patients from 6 months old to 95 years old. I have talked with family members and broken the bad news of cancer. I’ve been there, covered in sweat and blood, after over an hour of trying to resuscitate a co-workers 14 year old son. I cried after the 6 month old died in my arms and I got misty eyed when I did a pre-surgical check-in on a 37 year old woman with breast cancer whose mastectomy and axillary dissection I was about to assist on. But I find I know how to act and what to say in those situations and, of course, I always know that I am still distant from the situation.

    I’ve never had an experience where that distance was gone until now (which I’d say is definitely rather lucky on my part and partly to do with how small my family is) and it is strange because I find myself falling into my “clinical self” since that is the only “self” I have that has any clue as to what to do or say. But, of course, that response is simply inappropriate so I am left saying, “I don’t have a clue what to say or do.” And I also don’t really have the option to go home either, so it will be another 3 months before I have the opportunity to see any of my family.

    So I’ll try and refrain from making too many content intensive comments, since it seems clear my head isn’t all there at the moment. Besides, I really should focus on a few assignments I have to do and a pile of reading and practice board questions I need to keep cranking on.

  58. Jeff says:

    Nybgrus says,

    Because the point is that the manufacturing process and exactly what is in each pill is different now. That needs to be standardized and the best way is to make sure the final product is being tested, not just a list of ingredients that can be mixed and matched willy nilly.

    He seems to be completely unaware of the very stringent GMPs for supplements;

    http://www.fda.gov/Food/DietarySupplements/GuidanceComplianceRegulatoryInformation/RegulationsLaws/ucm110858

  59. nybgrus says:

    Jeff says:

    He seems to be completely unaware of the very stringent GMPs for supplements;

    He seems to be unable to address any of the actual points I’ve made and chooses to nitpick minor side points.

    If the law was particularly effective we would wouldn’t have stories of pills being tainted with toxins, the growing issue of tainted supplements passing through because DSHEA makes it tough to regulate, the fact that they are hard to remove from market even after being positively identified as tainted, nor the main crux of my argument which is that in a person with a reasonable diet and who is otherwise reasonably healthy supplements likely do more harm than good and for those that aren’t healthy they should not be seeking to self medicate since significant harm can come from it when they are misled into thinking a “natural supplement” is a better or even viable alternative to seeking actual medical care.

    It is pretty simple, really. A certain, small, percentage of supplements and drugs are indeed reasonable to have OTC. We can’t know which ones without actual data. The majority are either completely useless or actively harmful to most people so there is no point in having them. The remainder are actually active and could be helpful in people with actual disease states, but that should be managed by someone actually trained in managing such things, like, oh I don’t know, a physician.

    It boggles my mind that if I were to go out and claim that I could make informed decisions about engineering and have the freedom to build whatever, wherever, however that would be considered ludicrous. Nobody is clamoring to get rid of engineering oversights and building code and regulatory bodies. But when it comes to taking chemicals (yes, natural products are chemicals too) to diagnose and treat yourself, somehow regulation of that is simply ridiculous and arguments like “You think American consumers are simply too dumb and ignorant to make rational, independant decisions regarding their own health.” I think that they are just as dumb and ignorant about health as most are about building codes. So when my neighbor wants to build a structure on his property I would expect him/her to be required to pass the relevant codes via a reasonably rigorous oversight committee.

  60. JPZ says:

    @nybgrus

    I hope you can pardon the assumption about nationality!

    @Jeff

    First, teratogenicity testing of every finished product is not required under the new NDI proposal. The FDA proposal requires a new NDI to be filed for each reformulation (a very silly recommendation that makes no one any safer IF the contents of the reformulation are all safe and GRAS ingredients). My read is that the safety package of the reformulation NDI could simply reference an existing manufacturer NDI or a GRAS filing if there are no chemical changes to the ingredient.

    A new dietary ingredient being released to the public for the first time (i.e. not pre-1994 exempt) in a chemical form for use in a supplement must have safety testing. If a company can’t take financial responsibility for ensuring their product is safe, they should not be releasing new dietary ingredients. DSHEA grandfathered every dietary supplement ingredient on the market before 10/15/1994 – not based on safety data but on regulatory expedience (like they did with drugs in 1938). The proposed NDI guidelines cover nutritional ingredients released after that date. Ingredient suppliers can’t expect every nutritional product to be exempt from regulatory oversight just because other companies “got lucky” by having pre-1994 ingredients.

    Second, retinol is teratogenic. Several other herbs are abortifacient or stimulate uterine contractions. There was a great book out there reviewing all the literature on dietary supplements during pregnancy and lactation. If I come across it, I’ll post the link here.

  61. Jeff says:

    @nybgrus:

    Under current federal law Companies selling adulterated products face enforcement actions such as product seizures, injunctions, fines, and criminal prosecution. Further, the individuals involved can also face fines and criminal prosecution. Regulation is not the problem – Fortunately the FDA is finally getting serious about enforcing laws against adulteration:
    http://www.naturalproductsinsider.com/blogs/jon/2011/06/seven-years-prison-for-supplement-fraud.aspx

    A superficial, uninformed newspaper article won’t convince me to give up my supplements. I believe in freedom of choice – nybgrus doesn’t. I believe American consumers should have unrestricted access to safe, affordable dietary supplements. The vast majority of consumers are willing and able to decide what to put in their own bodies. Nybgrus thinks he knows what is best for the rest of us.

    JPZ: Very few supplements have stayed the same since 1994: dose levels change, ingredients get added or subtracted. If an NDI filing is required for every new supplement and every new supplement formula, wouldn’t this include virtually every product on the market? And as soon as an NDI filing is made, the product must be pulled from the market to wait for FDA approval. This kind of regulatory overkill seems intended to throw the industry into chaos.

  62. JPZ says:

    @Jeff

    If you think you can outsmart hundreds of marketing professionals at dozens of irresponsible dietary supplement companies with years of experience fooling people, more power to you.

    I agree that a NDI filing for every new formulation is a bad idea (I think I said that a few times). I am doing my best to correct any misinformation about this new NDI process. You would not have to pull a product from the shelves when filing a NDI, since a NDI is only for products that have never been on the shelves.

  63. Harriet Hall says:

    @Jeff,
    ” I believe American consumers should have unrestricted access to safe, affordable dietary supplements.”

    So do we all. Hear, hear! The legislation was intended to improve the “safe” part.

    “The vast majority of consumers are willing and able to decide what to put in their own bodies.”

    Willing and able to decide, sure. But that doesn’t mean their decisions will necessarily be in their best interests. Science-based medicine wants them to have accurate information to make informed decisions.

  64. JPZ says:

    @Harriet Hall

    “The legislation was intended to improve the “safe” part.”

    My apologies if this sounds “picky,” but the NDI guidelines are not exactly legislation. The FSMA law required FDA to develop these guidelines, but the guidelines themselves are considered “rule making.” The only reason the distinction is important is that rule making has a comment period before it goes into effect, and it is much easier to change rule making during the comment period than it is to change legislation. I am hoping some of the poorly thought out parts of these guidelines will get fixed after the comment period. I feel a little silly bringing this up since I am guessing you already knew it.

  65. Jeff says:

    JPZ:
    My understanding was that the guidance is retroactive to 1994. The law firm Emord & Associates authored a legal analysis of the Draft Guidance, which can be read in its entirety by Google searching this phrase:
    “Docket No. FDA-2011-N-0410, Comments of Alliance For Natural Health”

    From that document:

    The Guidance provides an expansive definition for the term NDI. Consequently numerous dietary ingredients in the marketplace, presumed lawful by the industry and consumed safely for years, are now adulterated by operation of law under the agency’s “current thinking”, explained in the Guidance at IV (B)(1); IV(B)(3); and IV(B)(4), and must be removed from the market.

    Harriet Hall:
    All the available data show that supplements are already safe. In his post David Kroll links to comments by Bill Sardi. From those comments:

    There is no dietary supplement in current use that has been identified as a significant threat to public health. So compliance with the new NDI guideline may end up being a paperwork exercise rather than a true advancement in ensuring dietary supplement safety…..The fact that there are no documented outbreaks of toxicity or birth defects that have been attributed to dietary supplements that have been introduced since the passage of DSHEA in 1994 suggests this is purely an expensive bureaucratic paperwork exercise that has no meaningful endpoint in mind.

  66. Scott says:

    “We don’t have any particular evidence that supplements are unsafe (but we haven’t really looked)” is a very different statement than “all the available data show that supplements are already safe.”

  67. JPZ says:

    @Jeff

    Jonathan Emord was the plaintiff lawyer in Pearson v. Shalala where he argued (based on my non-lawyer read of it) that the FDAs barring of scientifically unsupported claims for dietary supplements was a violation of the first amendment – and he won. Call that pro-free speech or anti-science, take your pick. I am not sure I have ever seen him say anything positive about about the FDA and dietary supplements.

    Here is a quote from Bill Sardi’s website, “Conventional medicine is collapsing, and it’s being brought down by scientific studies which reveal modern medical treatments simply are worthless.” Check out his other books (http://www.naturalhealthlibrarian.com/).

    I think Jonathan is postulating a worst-case scenario, and Bill is neither a scientist nor a physician. These are not exactly unbiased sources.

  68. nybgrus says:

    @Jeff:

    I believe in freedom of choice – nybgrus doesn’t.

    Yet you balk at giving me the freedom to choose marijuana and heroin poppy extract. Marijuana in particular has a long standing history of generally safe use, it is all natural, and it contains compounds naturally found in my body that I could “supplement.”

    I am not against freedom of choice.

    I believe American consumers should have unrestricted access to safe, affordable dietary supplements.

    It has not been established they are safe. Scott accurately pointed out your error here. The same one I have been saying ad nauseum.

    The vast majority of consumers are willing and able to decide what to put in their own bodies.

    I’d like to put some marijuana, heroin, a dash of methamphetamine, a little gingko biloba, and some extract of hemlock in my body and then wash it all down with some acai berry juice and a handful of goji berries. Just like the “vast majority of consumers” I have just demonstrated my willingness and ability to decide what to put in my own body. Therefore, by Jeffesian logic, I should be able to demand that such products be available OTC.

    I do not want to tell people what to do with their bodies – in fact I am for the legalization of marijuana – but I want to have people accurately and adequately informed. So if marijuana were legal it would still have some restrictions on use and a warning of the known health affects would be necessary. Much like tobacco. The problem is that the myriad products currently available do not have such data and I’d rather have them unavailable as a result.

    Nybgrus thinks he knows what is best for the rest of us

    I don’t. I think that the body of scientific knowledge and literature does. And when we don’t have such a body of knowledge, the answer is not “this is safe and useful.” It is “this should be considered unsafe and not useful until proven otherwsie.”

    I am very much for a free market economy. If your feverfew and gingko actually does do amazing things then they will make money in spades. But I am also about protecting consumers from snake oil salesmen. You claim I am against freedom of choice – I counter and say that you are against consumer protection and rights to know. You’d rather people get hoodwinked and potentially hurt than remove their freedom of choice, and yet at the same time refuse to see how that logic leads to marijuana and heroin poppy extract on pharmacy shelves.

  69. nybgrus says:

    @JPZ:

    I hope you can pardon the assumption about nationality!

    Of course!

  70. Scott says:

    I could credibly argue that Jeff is against freedom of choice. Making a real choice requires that one have adequate information on which to base that choice. Otherwise you’re just flipping a coin.

  71. You know, every time there is a new regulation, spokespeople for the regulated industry wring their hands about how it’s going to be the end of that industry, or how many small businesses it will put out of business.

    GP did it when consumers demanded that they not increase their dumping of wastes into Lake Michigan, The Tobacco industry did it, The car companies do it, the banks are doing it now.

    As I see it, all this whinging is just a way to say, “Hey! we don’t want to pay the cost of making our product safe, reliable or honest, we think the tax payer should, then we can pass on more dollars to our owners or shareholder.”

    I’m tired of it and I have very little sympathy for it.

    If supplement companies can not bear the financial burden of regulation, then I guess that just means that a safe, honest supplement is not a cost effective solution for most consumers. I doubt that will happen, but hopefully the next industry that pops up will build it’s foundation knowing that it will have to deal with safety and honesty when they manufacture a product.

  72. nybgrus says:

    good point Scott. “random decision” and “informed choice” are indeed very different.

    Huzzah for michele! I agree :-D

  73. JPZ says:

    LOLs for @Scott and sympathy for @micheleinmichigan.

    @Jeff

    I may be the only person on SBM who has filed a NDI (years prior to this guidance). It was 700 pages long (including references), had a full panel of tox studies, and was approved. Other companies filed one page NDIs and threw a hissy fit when it wasn’t approved. To me, the proposed guidance would have made my job a lot easier. Between what I did and what other companies did, this is a nice middle ground proposed by the FDA (overall – discounting the silly parts of the guidance).

  74. Jeff says:

    This new article makes it clear the supplement trade groups are gearing up for a fight over the Draft Guidance. The severe economic damage it could cause their industry ensures they won’t passively accept it.

    http://www.nutraingredients-usa.com/Regulation/Hatch-NDI-guidance-meeting-File-comments-for-now-then-explore-legal-avenues

  75. So here’s a story and a thought.

    I used to work with a woman who was a DES daughter. She had lost one sister to the form of cancer associated with DES, had another sister who had ovarian cancer (I believe, surprisingly in remission) and her brother had recently been diagnosed with cancer that they seemed to suspect was related.

    So DES was a hormone used to treat infertility. I’m assuming that the fact that children from the pregnancies where DES was used experience more cancer of a particular type was found through science that compared DES daughters to a control group over time. How did they find the DES daughter? What was the likelihood of women remember they took DES, or their being records of women who took DES? Well the DES was a prescription. So I would say that the liklihood of records at doctor’s offices and pharmacies was good. People probably remember taking a prescription better than a OTC or remedy, but that’s speculation. Regardless, due to the fact that they could track down the DES pregnancies they were able to find the connection between DES and cancers in young women.

    If you go to a health food store, you can find various supplements claiming to increase fertility. Some of them probably contain chaste berry, which seems to contain or affect reproductive hormones.

    What are the short term, long term effects of chaste berry? What is the system in place that will allow science to investigate long term consequences if they exist? There are no doctor records, there are no pharmacy records, many consumers will not remember the name or ingredients list of a GNC fertility supplement they took. They may even think they are just taking a prenatal vitamin.

  76. My post is wrought with mistakes. I won’t try to correct them all, just my apologies.

  77. nybgrus says:

    I think I still understood what you meant despite the mistakes ;-)

    I think you might be my favorite commenter here michele.

  78. You are too kind, nybgrus, but thanks.

    I’m pretty sure I used to be able to preform reasonable quality editing when I was working as a designer. All those creative briefs and brochures didn’t end up with this many errors. But it seems my aging eyes and brain and/or the comment box medium has resulted in a serious degradation of editing results.

Comments are closed.