One of the reasons DSHEA, the Dietary Supplement Health and Education Act of 1994, was created was to define dietary supplements very clearly as food and not drugs. This is critical to maintaining access to high quality, natural food-supplements.
Unfortunately, the FDA is considering significantly expanding the scope of its guidance called “Toxicological Principles for the Safety Assessment of Food Ingredients”—also called “the Redbook”—to inappropriately include nutritional supplements and supplement ingredients.
Concerns about Redbook
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, but this is likely what the FDA has in mind.
Including supplements in Redbook blurs the line between food additives and dietary ingredients. In 1994, when DSHEA was introduced, Sen. Orrin Hatch said, “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.”
The last time FDA attempted to overtly apply food additive standards to dietary supplements, the agency’s efforts were soundly rejected by not one but two US circuit courts of appeals.
Redbook should wait for the new NDI guidance
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, meaning the supplement industry does not know for certain which products are “grandfathered” in and which require NDI notification. Supplement manufacturers who might be wishing to file an NDI notification for their product should postpone setting up any necessary toxicological and safety studies until after the new NDI guidance is released.
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, Sen. Hatch and then-Sen. Tom 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.”