Federal law makes it very clear that food additives and supplements are not to be treated the same way. But once again the FDA doesn’t seem to care about the law. Action Alert!
Last month the FDA held an open meeting to receive input from the public on updating “Redbook.” That’s the agency’s informal term for its guidance called “Toxicological Principles for the Safety Assessment of Food Ingredients.” The FDA is considering significantly expanding the scope of the guidance to include nutritional supplements and supplement ingredients.
Redbook 2000, the current version, details what the FDA would expect to see from manufacturers who are seeking approval of a new food or color additive in terms of animal toxicological studies.
Unfortunately, the FDA has not been very open at this stage about how exactly they plan to include dietary supplements in Redbook. But we are very concerned by this development for a number of reasons:
- Redbook was designed as a how-to guide to prove that food and color additives are safe for pre-approval. This is a troubling paradigm to impose on dietary supplements which, by law, are specifically not subject to FDA approval. Furthermore, the evidentiary standard for dietary ingredients (which includes supplements) is very different from the standard for food additives: dietary ingredients need to have a “reasonable expectation” of safety, whereas food additives must have a “reasonable certainty” of safety.
- The law says that supplements on the market before 1994 are “grandfathered” into the system—that is, they are considered safe by their history of long use by the public, and do not require FDA review. If supplements get subsumed into Redbook, would it mean grandfathered ingredients would have to prove their toxicological safety? This could endanger thousands of supplements because of what we call the “Catch-22” of drug economics.Drug companies can pay the huge sums for toxicological studies because they are working with non-natural, new-to-nature (and new-to-the-human-body) substances that can be patented and turned into huge money-makers. But who would spend that money on toxicological studies for natural supplements, knowing that anyone could produce and sell it with out a patent? The answer is obvious: no one. So the real FDA intent is simply to eliminate any competition for patented drugs, since these drugs pay the agency’s bills. Besides, supplements were grandfathered initially because, according to Congress, they had such a long history of safety—so toxicology studies are, by definition, unnecessary.
- Including supplements in Redbook blurs the line between food additives and dietary ingredients—something Sens. Orrin Hatch (R-UT) and Tom Harkin (D-IA) explicitly stopped Rep. Henry Waxman (D-CA) from doing legislatively when DSHEA was being crafted twenty years ago. As Sen. Hatch said when that landmark legislation was introduced, “For more than three decades, FDA has tried to restrict severely the ability of the dietary supplement industry to sell and market its products and, consequently, the ability of consumers to buy them. The agency has repeatedly attempted to impose unnecessarily stringent standards that would leave many if not most supplement companies with no practical choice but to close their doors….[DSHEA] makes clear that dietary supplements are not food additives or drugs, and that the burden of proof shall be on the FDA to prove that a product is unsafe.”
The last time FDA attempted to overtly apply food additive standards to dietary supplements, the agency’s efforts were soundly rejected—dare we say ridiculed—by not one but two US circuit courts of appeals:
- In US v. Traco Labs, the Seventh Circuit stated that “the only justification for this Alice-in-Wonderland approach is to allow the FDA to make an end-run around the statutory scheme and shift to the processors the burden of proving the safety of a substance in all circumstances.”
- In US v. Oakmont Investment Co., the First Circuit wrote, “The proposition that placing a single-ingredient food product into an inert capsule as a convenient method of ingestion converts that food into a food additive perverts the statutory text, undermines legislative intent, and defenestrates common sense. We cannot accept such anfractuous reasoning.”
In 2011, we wrote that FDA seemed to be determined to try the same tactics the agency used in 1994 when it tried to derail DSHEA—and here we go again. David Kessler, then FDA commissioner, ordered FDA not to enforce DSHEA because he was convinced that the worst elements of the dietary supplement industry would then come to the fore, causing Congress to repeal the law. This of course did not happen.
Expanding Redbook to include nutritional supplements is, at any rate, premature, given that the next version of the NDI (new supplement) guidance has not yet been released. Any required toxicological and safety studies for NDI notification should be addressed after that release.
In addition, if both the NDI guidance and Redbook end up addressing safety data for dietary supplements, it will lead to massive industry confusion, which will ultimately choke innovation, raise costs, and limit access to supplements. This may be exactly what the FDA wants in order to shield drugs from competition.
Not surprisingly, Sens. Hatch and Harkin sent the FDA a letter expressing their concern about Redbook, noting that “DSHEA contained an essential exclusion of dietary ingredients from the statutory definition of food additives,” and that the NDI guidance for dietary ingredients should be handled quite separately from Redbook: “The statutory clarity between dietary ingredients and food additives necessitates that guidance documents be separately released for these two different types of ingredients.” They also note that if FDA moves forward in including dietary ingredients in food additive paradigm, it would require rulemaking.
ANH-USA is preparing formal comments and will submit them shortly. Action Alert! Tell the FDA that Redbook should not be expanded to include dietary ingredients, and that any safety assessments for dietary ingredients should be addressed strictly in the context of the NDI guidance. Send your message today!