Signed into law by President Clinton on October 25, 1994 after being adopted by unanimous consent by a Congress that received in excess of 2.5 million letters urging its passage, the Dietary Supplement Health and Education Act of 1994 (DSHEA) expressly provides that dietary supplements and the ingredients therein that were on the market as of October 15, 1994 are presumed to be safe for consumer use. DSHEA also established that dietary ingredients (ingredients used in dietary supplements for the purpose of effecting the structure or function of the body) introduced after October 15, 1994 are subject to a 75-day premarket notification requirement and must present evidence that there is a “reasonable expectation” that the ingredient will be safe for its intended use. Ingredients for which no such notification has been provided to FDA are considered adulterated per se under the law.
On October 30, 2014, FDA published a Federal Register notice announcing that the Agency intended to revise the Guidance “Toxicological Principles for the Safety Assessment of Food Ingredients,” or the “Redbook”, also noting that it was considering expanding the Redbook’s scope to include, among other things, dietary supplements. Any such expansion of The Redbook which “provides guidance to industry and other stakeholders (e.g., academia, other regulatory groups) regarding toxicological information submitted to the Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Additive Safety (OFAS) regarding food ingredients” constitutes an impermissible attempt to treat dietary ingredients used in dietary supplements as food additives, in direct contravention to DSHEA. These concerns were expressly noted in a December 8, 2014 letter from Senators Hatch and Harkin to FDA Commissioner Hamberg.
Under DSHEA, new dietary ingredients are expected to be made available to the consumer based upon a “reasonable expectation” of safety. Conversely, the food additive standards embodied in the Redbook require a demonstration that there is “reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use.” The standard of “reasonable certainty” is materially different from “reasonable expectation”. In essence, the former requires that every potential question concerning the safety of a food additive be addressed before such an ingredient can be used. The standard “reasonable expectation” however, allows for the possibility that an outlier study or journal article need not be rebutted.
The difference between these standards is further illustrated by reference to the Merriam-Webster dictionary, which defines expectation as “a belief that something will happen or is likely to happen”. The same resource defines certainty as “something that is certain: a fact about which there is no doubt”.
The last time FDA attempted to overtly apply food additive standards to dietary supplements, the Agency’s effort was roundly rejected and ridiculed by two United States Circuit Courts of Appeals.
In US v. Traco Labs (984 F2d 814, 1993) 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”.
And, in US v. Oakmont Investment Co (987 F.2d 33, 1993) the First Circuit announced its conclusion that “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.”
The 1993 dates of these decisions and 1994 passage of DSHEA is no coincidence. Congressional reaction to the Circuit Court’s condemnation and other Agency actions indicating a vast Agency overreach was to pass DSHEA, and amend Section 201(s) of the FDCA (21 USC 321(s) to exclude dietary supplements from the statutory definition of “food additive.”
For FDA even to consider placing supplements into the Redbook and within the food additive framework provides evidence that we continue to deal with a two-decade long institutional temper tantrum over the passage of DSHEA. FDA’s hostility toward DSHEA has been noted by many, including Peter Barton Hutt (a former Chief Counsel at FDA) who, in a September 21, 2009 article published in the Natural Products Insider, documented cynical instructions from former Commissioner David Kessler that Agency officials not enforce the law in the hope that an unregulated industry would create a public health crisis forcing Congress to repeal DSHEA. The effects of Commissioner Kessler’s directive are more than evident when one considers that it took over a decade for FDA to promulgate good manufacturing practices for dietary supplements as it was specifically directed to by DSHEA.
Today, the supplement industry continues to await republication of the New Dietary Ingredient Guidance, following the Agency’s broken promise made in the CFSAN Plan for Program Priorities to issue a revised draft Guidance in 2013 after near universal condemnation of its 2011 draft which contained 13 separate references to standards established for food additives by the Redbook.
Beyond violating the specific provisions of DSHEA, adoption of the food additive standard of “reasonable certainty” will have serious potential for stifling innovation by discouraging development of new supplement ingredients. Increased costs, possible loss of intellectual property protections because the “reasonable certainty” standard may create a framework wherein dietary ingredient marketers are unable to rely on proprietary/unpublished studies as is currently permitted with NDI notifications, and higher burden of proof will likely cause fewer companies to pursue the introduction of new ingredients with substantial public health benefits—for example astaxanthin—into the marketplace, thus harming both the trade and the public health.
FDA’s proposed action is even more inexplicable in light of the Agency’s possession of information that knock-off new dietary ingredients offered by unscrupulous producers are being foisted upon American consumers. My firm has presented the agency with reliable evidence of unethical companies continuing to import these adulterated ingredients with unidentified peaks and huge amounts of residual chloroform. We have asked for enforcement action on behalf of legitimate companies that have undertaken the expense to comply with the New Dietary Ingredient process, yet none has been forthcoming. At a time when FDA has inexplicably failed to issue an import alert blocking these scofflaws, we can only wonder why the Agency would engage in a distraction such as the one we are seeing today.
Written comments are due to FDA by February 9, 2015. Interested companies and consumers of dietary supplements should consider providing FDA with submissions urging the Agency to comply with DSHEA and enforce the law rather that wasting resources trying to circumvent the will of Congress and the American consumer.
Marc Ullman is a partner in New York City based Ullman, Shapiro & Ullman. His practice focuses on the dietary supplement/natural products industry with a particular emphasis on FDA and FTC compliance issues including Good Manufacturing Practices and product claims.
Published by WholeFoods Magazine Online, 1/14/15
