Marc Ullman, Of counsel

December 5, 2013

4 Min Read
Is My New Dietary Ingredient Really New?

During his Featured Speaker presentation at SupplySide West on Nov. 14, FDAs Daniel Fabricant, Ph.D., caused a great deal of consternation amongst a group of attendees when he addressed the agencys fundamental positions on new dietary ingredients (NDIs). Of particular concern was Fabricants statement alerting attendees that, just because something is found in a botanical doesnt mean [FDA] considers it part of the food supply." In other words, isolated botanical constituents are not automatically exempted from having to file a new dietary ingredient notification (NDIN), even if it can be demonstrated that the whole botanical in which it can be found is commonly used in the food supply" somewhere. A review of the NDI provisions in the Dietary Supplement Health and Education Act of 1994 (DSHEA) reveals that, while many in Fabricants audience were surprised by this statement, they should not have been.

The law governing NDIs can be found in Section 413 of the Federal Food Drug and Cosmetic Act(FFDC), 21 USU §350b. This part of the law, which was added to the FDCA when DSHEA was adopted in 1994, established that a dietary supplement containing a NDI is adulterated unless it satisfies one of two conditions. The first is that FDA receive a NDIN at least 75 days in advance of the ingredients introduction into the market demonstrating that there is a reasonable expectation the ingredient will be safe for its intended use. Alternatively, no NDIN is required if the dietary supplement contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered." It is the use of the words as an article used for food" that should make it obvious Fabricant was not staking out any new ground with his comments at SupplySide West.

The problem, however, is that when the NDIN requirement is discussed, the question is generally framed as Was the substance present in the food supply in a form not chemically altered?" By pushing the discussion in this direction, companies that do not want to deal with the notification process have been able to bypass the as an article used for food" clause in the law. This has caused the issue to be framed as (for example):

Question: Is there any aegeline in the bael fruit?

Answer: If yes, then it must be OK to use without submitting a NDIN since aegeline is in the food supply."

(For the purposes of this discussion, we can set aside the natural/synthetic question, which relates to the question of whether a synthetic substance is even a dietary ingredient eligible for use in dietary supplements in the first place.)

When you look at the statute, the real question should be: Has aegeline been present in the food supply as an article used for food in a form not chemically altered?" This means aegeline must be the article. The statute doesnt say present in the food supply in an article used for food;" it states the NDI must be the article itself consumed as food.

This means there needs to be some history of intentional consumption of aegeline as an ingredient itselfnot just as part of the bael fruit. This holds true for any constituent of any botanical or other prospective dietary ingredient. Unless the constituent was intentionally consumed as a food ,the plain language of the statute does not provide exemption from the requirement to submit a NDIN 75 days before the constituent is offered for sale as a dietary ingredient. Similarly, the presence of trace amounts of PQQ (pyrroloquinoline quinone) in breast milk or synthetic astaxanthin in animal feed does not constitute presence in the food supply as an article used for food" exempting the producers of these substances from the 75-day notification requirement.

This reading of the law also is the only one that makes sense. If all a company had to do was show that the substance in question could be found in some herb, plant or algae that had been consumed as food somewhere at some time, then almost everything would be exempt from the NDIN requirement. Interpreting the law to allow for such a narrow reading of when a NDIN is required would also negate any potential for the statute to protect public health as it would permit the marketing of substance such as aegeline (or DMAA or any other constituent of almost any botanical) at extreme concentrations well beyond those found in nature without any serious examination of potential toxicological impact on human health.

When you look at the actual words of statute, this really should be a simple question and nobody should be surprised that just because something is found in a botanical doesnt mean [FDA] considers it part of the food supply."

Marc Ullman is a partner at the New York-based law firm Ullman, Shapiro & Ullman LLP

For a DVD copy of Daniel Fabricant's presentation, visit the SupplySide Store .

About the Author(s)

Marc Ullman

Of counsel , Rivkin Radler

Marc S. Ullman represents clients in matters relating to all aspects of Food and Drug Administration regulatory issues with a focus on the dietary supplement/natural products industry; Federal Trade Commission proceedings and litigation concerning consumer protection compliance and response to enforcement actions, concerning advertising practices, privacy and cyber security. Previously, he practiced with one of New York’s leading white collar criminal defense firms for ten years, where he represented clients in both federal and state prosecutions, as well as numerous related civil matters and other litigations.

Marc’s practice as part of Rivkin Radler’s Health Services Practice Group includes representation of clients on issues relating to FDA compliance, including labels, labeling, claims and good manufacturing practices. He has also represented clients in a number of complex adversarial proceedings with the FDA relating to the scope of the agency’s powers under the Dietary Supplement Health and Education Act of 1994 and its ability to seek remedies such as consumer restitution as well as counseling clients on general litigation related issues and most recently on complex legal issues of concern to the emerging hemp trade in the U.S.

He has represented clients in adversarial proceedings involving the FTC, including the negotiation of consent decrees and litigation regarding the adequacy of substantiation of advertising claims. Marc has appeared/testified on behalf of clients before the Food and Drug Administration’s Food Advisory Committee and at the FDA’s 2000 hearing concerning the impact of the First Amendment to the U.S. Constitution on FDA’s regulation of health claims concerning diseases. He has also counseled clients in connection with matters under investigation by the U.S. Congress.

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