Becoming a Dietary Ingredient the Hard Way

By Diane B. McColl & Riëtte van Laack –

On June 25, 2009, Ovos Natural Health Inc. ("Ovos") filed a citizen petition asking FDA to promulgate a regulation allowing use of homotaurine, a new dietary ingredient, in dietary supplements under sections 201(ff)(3)(B)(ii) and 301(ll)(2) of the Federal Food, Drug, and Cosmetic Act. Homotaurine, an amino acid found in certain species of seaweed (kelp), was the subject of an investigational new drug application ("IND") under which clinical trials were conducted for treatment of Alzheimer’s disease.  On the same date, Ovos also submitted a FDC Act §413(a)(2) premarket notification advising FDA of its intent to market homotaurine as a new dietary ingredient and the basis for its conclusion that there is a reasonable expectation of safety when used in accordance with the labeling.

This appears to be the first citizen petition asking FDA to authorize use of a substance through the notice and comment rulemaking exception to the 201(ff) dietary supplement exclusionary clause and the 301(ll) prohibition.  Past petitions concerning the section 201(ff) exclusion or the 301(ll) prohibition sought to  prevent the dietary supplement or food use of a substance.  See pyridoxamine petition, pyridoxal 5′-phosphate petition and stevia petition.

In view of the current uncertainty as to whether the 301(ll) prohibition applies to dietary supplements, it is not surprising that petitioner requested rulemaking under section 301(ll)(2).  In the recent Senate Appropriations Committee Report on S. 1406 – the Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act of2010 – the Committee noted that FDA has been slow to resolve the interpretation of 301(ll) and directed FDA to dispose of the issue.

The Ovos petition may well be a sign of things to come.  FDA is likely to see more requests for rulemaking as industry focuses on the limited routes to market for substances that do not succeed in drug development trials but offer nutritional value or other benefits as dietary supplements or food ingredients.  FDA can also expect to receive more petitions intended to prohibit , rather than permit, marketing under the 201(ff) exclusion and the 301(ll) prohibition as these provisions are factored into marketing strategies.