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Supplement Regulation: Be Careful What You Wish For

A recurring theme at SBM is the regulation of supplements, and the impact and consequences of the Dietary Supplement Health and Education Act of 1994 (DSHEA). As one of SBM’s international contributors, I thought it might be helpful to look at how the DSHEA stacks up against the equivalent regulations of its neighbor to the north, Canada. Given the multiple calls for overhauls and changes to DSHEA, an international comparison may help focus the discussion around what a more science-based framework could look like.

Briefly, the DSHEA is an amendment to the U.S. Federal Food, Drug and Cosmetic Act that establishes a regulatory framework for dietary supplements. It effectively excludes manufacturers of these products from virtually all regulations that are in place for prescription and over-the-counter drugs. The FDA notes:

Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements. Manufacturers must make sure that product label information is truthful and not misleading. FDA’s post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising.


Quackwatch has excellent resources on the DSHEA, and SBM bloggers have brought up specific criticisms of the Act at posts like this, this and this. The main concerns with the Act can be summarized as:

  • DSHEA draws a crude distinction between food and drugs, even defining therapeutic and pharmacologically-active products (e.g., herbs, botanicals, some hormones) to be categorized as foods, and therefore eligible for DSHEA exemptions from the FDA’s drug regulations.
  • Manufacturers can put virtually any claim on a supplement, without any requirement to provide persuasive clinical evidence, as long as it’s accompanied by the Quack Miranda Warning: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.” Disease treatment claims are not permitted, but are typically restated as permissible “structure/function” claims, implying an ability to improve the structure or function of the body only. (Colloidal silver is one example)
  • There is a lack of regulatory oversight of manufacturing practices.
  • In multi-chemical products such as herbals, there is no standardization of active ingredient(s), nor are there mandatory purity guarantees.
  • There are essentially no pre-marketing requirements before selling products. Once available for sale, there is little ability for the FDA to issue cease-sale orders and recalls. Regulators can block the sale of products only after significant problems have been identified (i.e., ephedra)
  • The regulation of marketing claims is effectively left to the Federal Trade Commission (FTC), which can prosecute manufacturers for fraud.

The Canadian Regulatory Framework

Until several years ago, Canadian natural health products fell into a regulatory grey zone. Products were treated either as drugs, or as foods. Consultation began in the late 1990′s on a new framework to provide regulation and oversight to these products. In 2004, the Natural Health Product (NHP) Regulations, under Canada’s Food and Drugs Act, became a reality. The NHP Regulations cover nutritional supplements, probiotics, traditional Chinese medicine, vitamins, herbal products, and homeopathy – many of the same products that would be considered “dietary supplements” under DSHEA. Rather than fully regulating these products as drugs, or leaving them virtually unregulated, the NHP regulations were a regulatory compromise: implementing manufacturing quality and safety standards, while significantly relaxing the standards for product efficacy claims. The Natural Health Products Directorate is the unit of Health Canada (Canada’s version of the FDA) that administers the NHP Regulations. Health Canada assures Canadians of the following:

Through the Natural Health Products Directorate, Health Canada ensures that all Canadians have ready access to natural health products that are safe, effective and of high quality, while respecting freedom of choice and philosophical and cultural diversity.

Let’s look at the DSHEA through the Canadian regulatory framework lens. Does it set a science-based example?

Lowering the Efficacy Bar

One of the biggest problems with DSHEA is that it facilitates unsubstantiated efficacy claims. While DSHEA doesn’t apply to homeopathy, the NHP regulations do. Health Canada says that regulated products are “effective,” so what’s the evidence standard being applied?

Health Canada’s Evidence for Homeopathic Medicines: Guidance Document states that applications for licenses for homeopathic products must include evidence to support the “safety, efficacy, and quality” of a homeopathic medication. All “homeopathic medicine” must be from substances referred to in homeopathic pharmacopias, such as the Homeopathic Pharmacopeia of the United States (HPUS), or other references.

Under the NHP Regulations, if randomized, double-blind, placebo-controlled trials are not conducted, manufacturers can make efficacy claims based on “traditional uses”, i.e., anecdotal evidence of use and efficacy. The two most common types of traditional use claims are provings, and references to homeopathic materia medica, which are essentially compilations of provings. There is no objective evaluation of efficacy in provings or in materia medica. Health Canada offers a list of 59 references it will accept at “evidence”, with publication dates as old as 1834 — dating back before the germ theory of disease was proposed.

Consider the popular remedy Oscilliococcinum, sold as an influenza treatment. It’s prepared by decapitating a duck, taking 35 grams of its liver and 15 grams of its heart and fermenting it for 40 days. The solution then undergoes serial dilutions (1 part in 100) 200 times in a row, (in homeopathy lexicon, “200C”) and is dried on lactose/sucrose tablets. (Wikipedia notes that that in order to obtain even a single molecule of the original fermented duck, a volume of tablets greater that the mass of the entire universe would need to be consumed.) Consulting Health Canada’s NHP database (Search NPN 80014156 here) Health Canada has registered the product, with the labelled medicinal ingredient as “Extract of the liver and heart of Annas barbariae: 200C” and approved the following recommended use (translated from French):

Homeopathic medicine to relieve flu symptoms: fever, chills, body aches, headaches.

This is one consequence of Canadian regulation: the efficacy standard has been lowered so far, it’s meaningless. The Canadian regulatory process assigns distinct registration numbers, dosages, and specific “recommended uses” to hundreds of physically indistinguishable brands of sugar pills.

Shifting categories, let’s consider an herbal product. Ginkgo biloba was discussed back in December in the SBM post Ginkgo Biloba-No Effect. Yet the product Dr. Andrew Weil, M.D. Ginkgo Biloba is approved by Health Canada (Search NPN 80003088 here) with the following recommended use:

helps to improve memory. helps to improve attention. consult a health care practitioner for use beyond 6 weeks. [sic]

Again, the evidence bar is far lower than a critical appraisal of the evidence would suggest is accurate. The result? Arguably worse than under the DSHEA. Statements based on questionable evidence gain a regulatory stamp of approval.

Manufacturing Oversight

The NHP Directorate establishes manufacturing standards and issues site licenses. Good Manufacturing Practices (GMP) must be followed. Setting aside the labelling accuracy of homeopathic remedies, the licensure should provide consumers and health professionals with more assurance that what is on the label is actually in the product. Health Canada’s FAQs include a question on DSHEA and it states:

In the United States, dietary supplements are considered as food products under the Dietary Supplements Health Education Act (DSHEA) and, as such, claims may not be made about the use of a dietary supplement to diagnose, prevent, mitigate, treat, or cure a specific disease. These products are not subject to mandatory review, approval or quality requirements, including appropriate testing for identity, purity or potency of active ingredients.

However, GMP standards also exist for supplements sold under DSHEA, so it’s not clear if the NHP regulations impose more strict requirements for Canadian products.

Standardization

The NHP Directorate has created a series of monographs about dozens of single-ingredient products which are intended to provide more standardization of product labeling, dosing and constituents. All of this is worthwhile. Unfortunately a quick scan reveals some significant discrepancies between the current state of the evidence and what’s in the monographs. Harriet Hall’s recent SBM post on glucosamine points out there’s little persuasive data to suggest it has any meaningful effects. In contrast, the current Health Canada-approved monograph for glucosamine selectively cites the positive trials, and labels it effective for osteoarthritis pain. So while the Regulations may be supporting improvements in the consistency of the the finished products,  the evidence standards may be compromising their real-world utility.

Marketing and Post-Marketing Surveillance

One of most important elements of the NHP regulations is the implementation of pre-marketing registration requirements. That is, only products reviewed and deemed to meet minimal standards of product quality, safety, and the (relaxed) standard for efficacy claims are permitted to be sold. Unfortunately, even after after six years, thousands of products remain unregistered due to a backlog at Health Canada. Until then, these products continue to be sold. Despite the published standards for consumer advertising of natural health products, there seems to be little enforcement of these requirements. As noted by Tom Blackwell in the National Post,

Recent ads, for instance, tout unapproved natural remedies as being able to prevent diabetes, heart and eye disease, treat menopause and Parkinson’s and help melt away excess weight. By contrast, makers of prescription drugs are essentially barred from promoting their products directly to consumers at all.

Federal law says even natural products — considered generally safer — must be approved under the natural health regulatory system before they can publish or air any kind of ad, and even then must stick closely to the claims allowed in the licence. Many companies that are waiting for word on their applications have chosen to ignore that rule, however, while others have not even attempted to get approval, observers say.

This regulatory backlog seems to have complicated the enforcement of marketing claims, and advertising standards for both approved and unapproved products don’t seem to be facing any serious scrutiny. In Canada, the Competition Bureau is the agency most comparable to the FTC, but it doesn’t seem to have the same focus on actively and publicly prosecuting fraudulent claims. While it has on occasion required companies to change their messaging, it’s rare, and only when the company has gone beyond the already over-generous efficacy claims allowed through the regulations. Perhaps this situation will change when the registration backlog is eliminated.

With respect to product withdrawals, the Minister of Health has the authority under the NHP regulations to direct the stop sale of a product or to cancel licenses of products to prevent injury. Licenses can also be suspended for regulation contravention, or if a product does not appear to meet safety criteria. It’s difficult to directly compare the FDA to Health Canada in this regard, as most Canadian warnings echo FDA advisories for products that may or may not be sold in Canada.

A Science-Based Regulatory Framework for Supplements

Given the regulatory approaches of Canada and the USA, what might a science-based framework look like? I see at least four different perspectives towards supplements/NHPs. I’m sure more will emerge in the comments.

  • Consumers want products that are safe, and labeled accurately. They may consult health professionals, or make their own decisions about whether products are effective.
  • Science-based health advocates, like the contributors at this blog, argue that that product safety and quality are paramount, and efficacy statements must be based on good science. They argue against a different approval standard for products just because they’re deemed a “supplement.”
  • Free market advocates, and those that call for health “freedom” question the value of most regulation that inhibits choice, emphasizing personal responsibility over government-legislated consumer protection measures.
  • Supplement manufacturers generally seek a market where they face as few regulatory restrictions as possible, whether it be safety, efficacy, or quality.

Certainly, there is some common ground here. Many will likely be agreeable to a regulatory framework that give consumer and health professionals assurance that they’re being protected from health fraud and dangerous products. Even free market advocates generally accept that markets operate less effectively when consumers cannot evaluate benefits and consequences (risks). With respect to health “freedom” claims, I question if anyone anyone wants the “freedom” to be sold products that don’t contain what is claimed, or have not been evaluated to be safe. Turning to manufacturers, some may welcome more rigorous regulatory verification of their own quality processes, especially if it helps with market acceptance.

One approach to to a new framework could be to unbundle the various types of supplements and treat each according to the science. Herbal products and botanicals stands out as the most likely to benefit from some elements of the Canadian regulations. Without quality manufacturing and standardization of active ingredients, it is impossible to infer anything about a particular herb. However, with respect to homeopathy, it’s questionable if anyone benefits from the regulation of sugar pills.

The biggest differences in opinion will clearly be the standards for efficacy and safety claims. Supplements/NHPs will rarely be be supported by the rigorous data we require for prescription and over-the-counter drugs. Through the NHP regulation process, Canada effectively eliminated any meaningful efficacy requirements, to accommodate products like homeopathy. Yet if all treatment and efficacy statements are forbidden, the information will emerge elsewhere. It’s an issue that other regulators are grappling with, too. Ben Goldacre, writing in The Guardian, points out the European Union’s process, evaluating health claims for similar products, has rejected 80% of claims submitted for formal approval. Ben’s solution is unorthodox, but one that I’m starting to warm up to:

You’ll never stop companies making these claims. You’ll never stop people enjoying their claims. This game is at least 200 years old. The best solution I can foresee is an EU-mandated bullshit box, where people can say whatever they want about their product, where consumers can join in, but the game at last is clearly labelled.

Conclusion

Canada has implemented a supplement registration and regulation framework with the goal of assuring Canadians that natural health products are safe, effective, and of high quality. While its approach to manufacturing quality is laudable, there are significant shortcomings with respect to product efficacy standards, and the regulation of marketing. The DSHEA at least informs consumers that the labelled statements on supplements haven’t been evaluated by the FDA. In Canada, with approved products, such as homeopathy, recommended use statements have been both evaluated and approved.

Yet if we want to incorporate dietary supplements into science-based practices, consumers and health professionals need quality products, but also objective and transparent evaluations of efficacy. As a health professional that advises consumers on natural health products, I welcome any regulation assures me, and my patients, that what’s on label is actually in the bottle. Without this information, I can’t make evidence-based recommendations. Yet if a regulatory system doesn’t also properly inform consumers about product effectiveness and safety, how can they be expected to make rational decisions about their own health? Canada’s approach offers some lessons, but also some cautions, for those calling for supplement regulation.

Posted in: Herbs & Supplements, Politics and Regulation, Science and Medicine

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23 thoughts on “Supplement Regulation: Be Careful What You Wish For

  1. mdcatdad says:

    1994, not 1984

  2. windriven says:

    In a perverse way this all makes sense. There are organized constituencies that for pecuniary or ‘spiritual’ reasons wish to perpetuate woo.

    The medical community has largely found it easier to abet than to oppose, largely one supposes, because SBM is as much about what isn’t known as what is, and that is difficult to sell to a population that believes every problem is solvable in half an hour. Woo doesn’t have that problem; it has the answers for everything.

    The same can be said of the legislators who we entrust to ensure the safety and efficacy of medical treatments. There is no organized constituency demanding science based medicine, even within the highest reaches of medical education. Politicians never blow against the wind and the wind blows in the direction of woo.

  3. Jeff says:

    Mr. Gavura’s post contains a few innacuracies:

    1. The FDA requires reporting for serious adverse events. The rules are exactly the same for for dietary supplements and OTC drugs: serious adverse event reporting is mandatory. Only prescription drugs are required to report all adverse events, serious and non-serious.

    2. It is simply not true that manufacturers can “put virtually any claim on a supplement” without oversight. Makers of dietary supplements that make structure/function claims must submit a notification to FDA no later than 30 days after marketing the dietary supplement that includes the text of the structure/function claim. The FDA then has three options: a)The claim is approved, no further action is taken, and the manufacturer may continue using the claim. b) The FDA may require substantiation of the claim. If the substantiation is acceptable, the claim is approved. c) If the substantiation is insufficient, or if the manufacturer fails to provide substantiation, the claim is disallowed.

    The FDA and FTC can and will take enforcement action against companies making unsubstantiated claims: “The proposed consent agreement with Quigley would also prohibit that company from making any claim that any food, drug or dietary supplement can or will cure, treat, or prevent disease, or will have any effect on the structure or function of the human body, unless it has competent and reliable scientific evidence to substantiate the claim.”

    3. Only those supplement ingredients marketed before 1994 do not require any pre-market approval. Any supplement containing aNew Dietary Ingredient requires pre-market notification. The FDA has rejected approximately 75% of NDI applications since 1994, thereby keeping many potentially unsafe products off the market.

    4. At first Mr. Gavura states “There is a lack of regulatory oversight of manufacturing practices.” Then he does link to the new GMP regulations which are fully implemented as of June 2010.

  4. Dr Benway says:

    The best solution I can foresee is an EU-mandated bullsh_t box, where people can say whatever they want about their product, where consumers can join in, but the game at last is clearly labeled.

    Eh, what? Like a warning, “Manufacturer’s claims of efficacy are simply not true” that goes on the product by default until real evidence is produced?

    Cool.

  5. dwpeabody says:

    I’m sure there are extra regulations in place but the American system sounds like if you lable hemlock as a herbal supplement you could sell it at a natural health shop.
    I wonder if there is anyway to shock the regulatory system into change by getting something out to shops that was fatal. Obviously not selling it, but getting it to where it could be on the shelves of a shop tomorrow.

  6. Scott says:

    You can grind up Viagra, label it an herbal supplement, and sell it at a natural health shop. So yeah, hemlock would be quite viable.

    It can be dealt with only after the fact.

  7. windriven says:

    @ Scott-

    It chokes me to say much of anything in positive about FDA but:

    “You can grind up Viagra, label it an herbal supplement, and sell it at a natural health shop.”

    is not accurate. FDA has recently acted on a number of supplements that contain sildenafil or sildenafil analogues forcing their recall.

  8. Scott says:

    My point is that they had to act after the fact; the supplements were successfully marketed for some time first.

  9. windriven says:

    Agreed.

  10. Jeff says:

    I disagree with some of Mr. Gavura’s statements concerning DSHEA.

    1. The FDA requires reporting for serious adverse events. The rules are exactly the same for for dietary supplements and OTC drugs: serious adverse event reporting is mandatory. Only prescription drugs are required to report all adverse events, serious and non-serious.

    2. It is simply not true that Manufacturers can “put virtually any claim on a supplement” without oversight. Makers of dietary supplements that make structure/function claims must submit a notification to FDA no later than 30 days after marketing the dietary supplement that includes the text of the structure/function claim. The FDA has three options: a)The claim is approved, no further action is taken, and the manufacturer may continue using the claim. b) The FDA may require substantiation of the claim. If the substantiation is acceptable, the claim is approved. c) If the substantiation is insufficient, or if the manufacturer fails to provide substantiation, the claim is disallowed.
    The FDA and FTC can and will take enforcement action against companies making unsubstantiated structure/function claims: “The proposed consent agreement with Quigley would also prohibit that company from making any claim that any food, drug or dietary supplement can or will cure, treat, or prevent disease, or will have any effect on the structure or function of the human body, unless it has competent and reliable scientific evidence to substantiate the claim.”

    3. Only those supplement ingredients marketed before 1994 do not require any pre-market approval. Any supplement containing aNew Dietary Ingredient requires pre-market notification. The FDA has rejected approximately 75% of NDI applications since 1994, thereby keeping many potentially unsafe products off the market.

    4. At first Mr. Gavura states “There is a lack of regulatory oversight of manufacturing practices.” Then he does provide a link to the new GMP regulations for dietary supplements which are fully implemented as of June 2010.

  11. windriven says:

    @ Jeff

    Is there an echo in here?

  12. Jeff says:

    @windriven: I thought my first comment had vanished somehow (it’s happened before). instead it was only being held for approval. Unfortunately SBM doesn’t inform readers if a comment has been received and is being held for approval

  13. windriven says:

    @Jeff

    Understood.

    I have a few more substantive issue to raise.

    On item 1 you say, “The rules are exactly the same for for dietary supplements and OTC drugs: serious adverse event reporting is mandatory.” That’s true as far as it goes, but it doesn’t go nearly far enough. OTC drugs have to pass a series of serious regulatory hurdles demonstrating safety and efficacy before they ever hit the market. That’s not true of supplements.

    On item 2 you quoted this as evidence that “It is simply not true that Manufacturers can “put virtually any claim on a supplement” without oversight.”

    “The proposed consent agreement with Quigley would also prohibit that company from making any claim that any food, drug or dietary supplement can or will cure, treat, or prevent disease, or will have any effect on the structure or function of the human body, unless it has competent and reliable scientific evidence to substantiate the claim.”

    I won’t even bother to quibble about the difference between a ‘proposed consent agreement’ and a mandatory cease and desist order. Further, this involves a single action, not a proactive industry initiative. And what exactly do the feds mean by “competent and reliable scientific evidence to substantiate the claim.”? Is appearance in some obscure homeopathy tome “competent and reliable?”

    Item 3 is also misleading. “Only those supplement ingredients marketed before 1994 do not require PMA.” Well no duh. Supplements manufacturers package the same nonsense in different combinations all the time. St. John’s Wort has been around since Georgia got red clay. That doesn’t make it efficacious.

    On item 4, it is rather disingenuous to cite a long overdue action as proof of prudent federal oversight. Those of us in the legitimate medical manufacturing business have been adhering to GMPs for years.

    Gavura’s point was that supplement manufacturers have a much lower bar than do OTC med manufacturers. Cherry picking a few instances where the poor put-upon supplement manufacturers have to behave like the rest of us in the medical industry does not disprove Gavura’s thesis; close examination of the cherries rather proves his point.

  14. Scott says:

    2. It is simply not true that Manufacturers can “put virtually any claim on a supplement” without oversight. Makers of dietary supplements that make structure/function claims must submit a notification to FDA no later than 30 days after marketing the dietary supplement that includes the text of the structure/function claim. The FDA has three options: a)The claim is approved, no further action is taken, and the manufacturer may continue using the claim. b) The FDA may require substantiation of the claim. If the substantiation is acceptable, the claim is approved. c) If the substantiation is insufficient, or if the manufacturer fails to provide substantiation, the claim is disallowed.

    And yet in fifteen minutes last night, I saw commercials explicitly claiming that their supplements could:

    1. Make you lose weight.
    2. Cure ringing in the ears.
    3. Keep you from getting a cold.

    All with the Quack Miranda Warning. And only #3 even bothered dressing it up at all with a structure/function format.

    In practice, supplement manufacturers can claim whatever they jolly well please.

  15. Jeff says:

    @windriven:

    It’s certainly true that naturally-occurring substances (supplements) can enter the marketplace without meeting the same strict requirements as synthetic, lab-created substances (drugs). Supplements have a strong safety record, with remarkably few adverse events reported annually. St. John’s wort has a long history of safe use. As for efficacy, the Mayo Clinic’s website states, “Overall, the scientific evidence supports the effectiveness of St. John’s wort in mild-to-moderate major depression.” Individual consumers are perfectly capable of researching St. John’s wort and deciding if it or any other supplement is appropiate for them.
    Among industrialized countries the U.S. has the freest, most open market for dietary supplements. Health-conscious people around the world (Canada included) are buying affordable, high quality, American-made supplements which are not available in their own countries.

    The new supplement GMPs are causing consternation among some supplement manufacturers. Purchasing the technology needed to meet the new testing requirements will be costly. The FDA itself has predicted many of the smallest companies will be forced out of business, and supplement prices will be driven up, thereby reducing consumption. Some have suggested this was precisely the FDA’s intention when it came up with these new strict, drug-like manufacturing rules.

    There is one thing we could probably agree on: the FDA and FTC need to take swifter, stronger enforcement action against those companies making false, unsubstantiated claims. The claims made for some weight-loss products are outrageous.

  16. Scott says:

    @ Jeff:

    By any rational definition, such things as St. John’s wort cannot be considered “supplements.” They do not provide dietary nutrients. They are DRUGS. Untested drugs of unknown dose and low purity, to boot.

  17. windriven says:

    @Jeff-

    A complete ISO13485 paperwork+software solution that exceeds GMP requirements can be had for <$1000 from Amazon.

  18. Jeff says:

    @windriven:
    “According to FDA’s Regulatory Impact Analysis estimates, it will cost each supplement manufacturer between $62,000 and $99,000, depending on size, to comply with GMPs in the first year. Annual costs after the first year will range from $38,000 to $61,000.”

    @Scott:
    From the FDA’s website: “If you want to market a “new dietary ingredient” in a dietary supplement, you must be sure that the substance is considered to be a “dietary ingredient.” (See section 201(ff)(1) of the act (21 U.S.C 321(ff)(1)). A dietary ingredient is a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any of the above dietary ingredients.”

  19. Scott on herbal medicines: “By any rational definition, such things as St. John’s wort cannot be considered “supplements.” They do not provide dietary nutrients. They are DRUGS.”

    Jeff on the FDA’s definition of dietary ingredients: “A dietary ingredient is [...] an herb or other botanical[... .]”

    Yes Jeff, you have made Scott’s point about the inadequacy of the current irrational legislation quite nicely.

  20. Scott says:

    Or put another way, yes. The current official definition is irrational.

  21. windriven says:

    @ Jeff

    You don’t say what FDA bases the $62k-99k number on. I can tell you that our annual compliance costs aren’t in the tens of thousands of dollars range unless you presume that you wouldn’t be doing quality control at all if GMPs didn’t demand it. The difference between good fundamental QA practices and GMPs is paperwork.

    But look, the fact remains that supplement manufacturers aren’t being asked to do anything different from what other medical products companies have been doing for years. It is a cost of doing business.

  22. A few clarifications:

    You cannot sell something that is already registered with the FDA as a drug as if it were a supplement. But, companies can put “supplements” on the market and then it’s up to the FDA to track them down and take them off.

    The FDA is chronically underfunded – so that it does not have the manpower to enforce the weak rules it currently has. The system is basically designed to be ineffective.

    The FDA does not review supplement claims pre-market – that is why the warning says “these claims have not been reviewed by the FDA.” The FDA does not review or approve structure/function claims. Their mandate is limited to ensuring that companies do not make disease claims without approval. Once they determine a claim falls under structure/function they make no attempt to review its scientific basis.

    The FTC, however, can go after the claims for being fraudulent. But again – they have their finger in the dike.

    Better regulations would likely push out small companies and raise the price of supplements. That was exactly the reason given to oppose the FDA for drugs – but it was the only way to get rid of snake oil from the market. Now the snake oil is back, and the sellers of snake oil are making the same excuses for why they do not want to be regulated.

  23. Jeff says:

    Dr. Novella,

    1. Here’s a detailed description of the FDA’s requirements for substantiation of structure/function claims:
    http://www.khlaw.com/showpublication.aspx?Show=1218

    2. FDA policy concerning unsustantiated claims:
    http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/ComplianceEnforcement/ucm071547.htm

    Part 5, label violations:
    “Enforcement actions will be considered against products that bear egregious disease claims or structure/function claims that may be unsubstantiated. Products that bear inappropriate disease claims or that appear to bear egregiously false or misleading structure/function claims should be referred to CFSAN for evaluation.”

    3. Here’s an example of properly worded, but unsubstantiated structure/function claims which, after review, were disallowed by the FDA:
    http://www.infomercialwatch.org/fda/cortislim.shtml

    Currently the FDA does not have mandatory recall authority over drugs or supplements. The process of removing unsafe products from the market would certainly be quicker and less expensive if the agency had MRA.

    Supporters of the industry are trying to rectify the problem of underfunding at the FDA:
    http://www.naturalproductsinsider.com/news/2010/05/senate-bill-seeks-full-dshea-enforcement.aspx

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