FDA says current dietary supplement regulations make clear that citizen petitions can be filed to request approval of ingredients that were studied in clinical trials and were part of investigational new drug applications.

The agency makes the point in response to the Congressional Dietary Supplement Caucus' October 2009 questions about whether FDA provides sufficient guidance to the industry on using a provision of the Dietary Supplement Health and Education Act that allows an IND pathway for supplement ingredients.

In a letter dated Jan. 25 that caucus members provided copies of on July 28, FDA also says it has yet to make a decision on a provision of the FDA Amendments Act of 2007 that prohibits the use in food products of ingredients that were subjects of a publicly disclosed substantial clinical investigation.

Assistant Commissioner for Legislation Jeanne Ireland stated in the letter that no DSHEA changes are needed to facilitate the introduction of nutritional substances that were part of INDs before being removed from consideration as a drug ingredient. DSHEA already allows firms to file a citizen petition to ask FDA to approve, in case-by-case rulemakings, the use of an ingredient studied in publicly disclosed clinical trials and used in an IND, she said.

With the petition process available, "this provision of DSHEA does not require additional implementation steps on the part of FDA to become operational," Ireland said.

The letter responded to an inquiry from the caucus co-chairs, Rep. Jared Polis, D-Colo., and Republicans Jason Chaffetz, Utah, and Dan Burton, Ind.

The members said while Congress passed DSHEA in 1994, FDA left the industry "in limbo" by not explaining the "viable pathway" for marketing new ingredients after they were considered in INDs.

FDA maintains "the process for permitting the marketing of a product as a dietary supplement is clear," according to Ireland's letter.

Ireland added FDA is evaluating the first petition submitted for an ingredient previously studied in clinical trials for use as a drug - Ovos Natural Health's request concerning its homotaurine amino acid. The agency is not ready to announce its decision on the petition filed in June 2009, Ireland stated.

The lawyer for Ovos says FDA's delay threatens the firm's business. Food and drug attorney Marc Ullman pointed out while Ovos followed the required process and requested FDA's approval, other firms could bypass the regulatory step and launch homotaurine-containing products.

Ovos plans a 2010 U.S. launch of its Vivimind cognitive health supplement, contingent upon FDA's go-ahead for homotaurine. The Canadian firm already markets the product in other countries.

Ullman acknowledged Ireland's letter makes clear FDA interprets DSHEA as allowing firms to submit petitions for ingredients studied in clinical trials as long as the substance also was part of an IND. On the other hand, FDA leaves the industry without an answer on introducing ingredients that were studied in clinical trials but may not have been part of INDs.

A change in the agency's regulations required by Sec. 912 of FDAAA prohibits sale of foods that have an added approved drug, licensed biological or a product that underwent publicly disclosed substantial clinical investigation, regardless of whether an IND was filed for the substance.

A narrow interpretation of Sec. 912 could include supplement ingredients among the substances that, if included in previous clinical trials, would cause a food product to be banned.

"Do I have to get a regulation or can I go under the DSHEA process? That's the question the FDA hasn't answered. But for some reason, they've decided if you had an IND, DSHEA applies," Ullman explained.

Ireland acknowledged that the comment period for the agency's Sec. 912 deliberation closed in October 2008, but did not state when FDA expects to make a decision on the provision.

The Dietary Supplement Caucus, as Senate Appropriations Committee members did earlier in 2009, encouraged FDA to make a decision on Sec. 912. The lawmakers agree with the industry in arguing that the provision does not apply to supplement products.

-Malcolm Spicer (m.spicer@elsevier.com)

[Editor's note: This story appears courtesy of the editorial staff of 'The Tan Sheet,' your source for coverage of nonprescription pharmaceuticals and nutritionals. For a sample copy, call customer service at 800-332-2181.]

FDA Clear On Supplement Ingredient Petitions, But Still Fuzzy On Sec. 912

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