A rumble of discontent is being heard across the dietary supplement industry since a draft guidance document was published last month by the US Food and Drug Administration.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But to be sure, the FDA draft guidance on New Dietary Ingredients is a bit complicated. The draft guidance indicates that FDA doesn’t have a reference list of dietary ingredients that could be grandfathered in (i.e., sold before 1994).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?
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