Co-chairs of the Congressional Dietary Supplement Caucus wrote to the U.S. Food and Drug Administration (FDA) on October 22 asking the agency to allow supplement manufacturers to seek its approval for ingredients that were the subject of unsuccessful new drug applications. The Congress members—Democrats Jared Polis of Colorado and Robert Wexler of Florida and Republicans Jason Chaffetz of Utah and Dan Burton of Indiana—asked the FDA to make use of a dormant section of the 1994 Dietary Supplement Health and Education Act (DSHEA) that allows for companies to seek the FDA’s approval for new dietary supplement ingredients that had been clinically studied for potential drug applications.
The Caucus’s letter follows the creation of a citizen’s petition filed in June 2009 by OVOS Natural Health, a Canadian supplement company that is working to bring its new cognitive health ingredient homotaurine into the U.S. supplement market. OVOS’s parent company, BELLUS Health Inc., originally sought drug approval for its homotaurine ingredient, which is backed by more than 16 clinical studies. But after the FDA told the company that its study findings looked promising but that it needed to do more research, BELLUS decided it was time to go down the nutraceutical route, OVOS President and CEO Gary Schmid told Nutrition Business Journal in June. In September 2008, OVOS launched a homotaurine-based supplement in Canada under the Vivimind brand. Vivimind is sold by most major retailers in both the natural & specialty and mass market channels in Canada and has already captured a nearly 10% share of the country’s cognitive-health supplement market, Schmid said.
The OVOS petition asks the FDA to promulgate a regulation allowing use of homotaurine in dietary supplements under sections 201(ff)(3)(B)(ii) and 301(ll)(2) of the Federal Food, Drug, and Cosmetic Act. In a clause aimed at protecting pharmaceutical companies, the Federal Food Drug and Cosmetic Act (FDCA) states that a substance cannot be marketed as a dietary supplement if it has been authorized for investigation as a new drug. But under DSHEA, the FDA can approve on a case-by-case basis the use in supplements of an ingredient that was the subject of a failed investigational new drug application. Since the passage of DSHEA in 1994 the agency has not approved any such ingredients, and the OVOS petition is requesting that FDA implement this section of the law for the first time.
One company backing OVOS’s petition is the ingredient supply company Sabinsa Corp., which filed comments supporting the move on October 26. “As a company that invests heavily in science to back its products, we strongly believe that FDA needs to implement all parts of DSHEA including those portions of the law that ensure that companies engaging in serious scientific research can get their products onto the market,” Sabinsa CEO Jeff Lind said in a statement.
FDA has until the end of December to respond to OVOS’s citizen petition.
In its letter to the agency, the Congressional Dietary Supplement Caucus co-chairs said that “it is imperative that companies understand that there is a viable pathway to market their ingredients in the event that for reasons unrelated to safety they are unable to complete the drug approval process.”
NBJ believes that allowing companies to make use of all aspects of DSHEA to create commercial avenues for their well-researched ingredients will help to support those firms dedicated to serious science and bring more science-backed supplement products to U.S. consumers.
Related NBJ links:
Ingredient Trends Likely to Help Boost Sales in 2010
Pharma Goes Nutra: Could This be the Way of the Future for Supplements?
New GMPs Are Forcing Manufacturers to Demand Higher Quality Ingredients
Related Functional Ingredient Magazine links:
Brainy Ingredients Get Brawny