Hatch, Harkin Worry FDA Seeks to Apply Food Additive Standards to Supplements

WASHINGTON—Two U.S. senators this week raised concerns that FDA is considering applying food additives rules to dietary supplement ingredients.

In a government notice published in late October, FDA disclosed it was considering expanding the scope of the “Redbook" to include chemical safety assessments for all products over which the agency’s Center for Food Safety and Applied Nutrition (CFSAN) has authority, including dietary supplement ingredients among other things.

Such a move by FDA could increase the burden on companies seeking to establish the safety of new dietary ingredients (NDIs), according to Marc Ullman, a New York attorney whose specialties of law include representation of dietary supplement firms.

The Redbook is guidance for industry and other stakeholders, representing FDA’s thinking on a topic, although it is not binding on the agency or the public.

Bringing dietary supplement ingredients within the scope of the Redbook—known more formally as “Toxicological Principles for the Safety Assessment of Food Ingredients"—would undermine the Dietary Supplement and Health Education Act of 1994 (DSHEA), Sens. Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa) wrote in a Dec. 8 letter to FDA Commissioner Margaret Hamburg.

DSHEA excluded dietary supplements from the definition of food additives in the Federal Food, Drug, and Cosmetic Act (FD&C), said the senators, who were instrumental in the passage of DSHEA and have defended it for the last two decades.

“Accordingly, under the statutory framework, the scientific evidence and standards which apply to dietary ingredients should be viewed and evaluated separately from the scientific evidence and standards which apply to food additives," Hatch and Harkin declared in the letter to Hamburg.

Natural Products INSIDER reached out Wednesday to FDA for comment, but the agency had no immediate comment as of press time.

The senators’ letter was submitted to FDA ahead of a public meeting Tuesday that solicited public comments on potential changes to an updated Redbook.

Ullman of the law firm Ullman, Shapiro & Ullman LLP told FDA the distinction between food additives and dietary supplement ingredients is an important one.

Per DSHEA, dietary ingredients that were on the U.S. market as of Oct. 15, 1994 are presumed to be safe, Ullman explained Tuesday in prepared remarks to FDA on behalf of his client, Natural Organics Inc.

Dietary ingredients that were later introduced are subject to a premarket notification requirement, and evidence must be presented “that there is a ‘reasonable expectation’ that the ingredient will be safe for its intended use," Ullman said.

“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 lawyer noted in the prepared remarks. “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."

FDA’s Office of Food Additive Safety prepared the Redbook, whose original name (“Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food") suggested it has always been linked to the safety of color and food additives and not dietary ingredients, Hatch and Harkin said.

Aimee Nichols, director of government affairs with the Natural Products Association (NPA), made similar remarks in prepared comments during the public meeting.

Ullman also cited a pair of 1993 federal appellate court decisions that he said rejected the application of food additives standards to dietary supplements. Those decisions were handed down the year before DSHEA was passed into law.

Nichols pointed out that the Office of Nutrition, Labeling and Dietary Supplements is currently in the process of revising guidance NDIs. That document “will provide guidance of toxicological principles for the safety assessment of dietary ingredients, which is the appropriate venue for such distinctions," she said in the prepared remarks.  

“Possible updates to the Redbook regarding dietary supplements would create confusion and conflict amongst industry players who desire compliance, yet are faced with conflicting regulations through DSHEA and the NDI re-draft," Nichols added.