FDA delays brain health ingredient drug-supplement switch verdict

07-Jan-2010 - Last updated on 25-Feb-2011 at 17:45 GMT

The FDA has told Ovos Natural Health it needs more time to process the Canadian biotech firm’s petition to have its brain health offering, homotaurine, accepted as a new dietary ingredient (NDI).

Ovos was created in 2008 by its parent, Bellus Health, to facilitate the switch of the ingredient’s status from drug to dietary supplement after clinical trials failed to meet drug approval criteria – but the pathway is untested and it is this fact that may be contributing to the Food and Drug Administration delay.

In its December letter to Ovos’ legal firm, Ullman, Shapiro & Ullman, Barbara O. Schneeman, PhD, director of the Office of Nutrition, Labeling and Dietary Supplements at the FDA’s Center for Food Safety and Applied Nutrition Center for Food Safety and Applied Nutrition wrote:

"We have not been able to reach a decision on your petition within the first 180 days of its receipt because of other agency priorities and the limited availability of resources. We will complete our review of your petition and consider any amendments to our regulations as warranted and in the context of other program priorities within the Center.”

Positive signals

The synthetically manufactured amino acid, called Vivimind, has already won approval for use in dietary supplements in Italy and Spain and Health Canada has given positive signals towards the dossier it has been assessing, Ovos president and chief executive officer, Gary Schmid, told NutraIngredient-USA.com.

“Winning approval in our country of origin is a very significant step for us and the indications from Health Canada have been very positive,” he said. “They like what they have seen. We remain on target to have this approval completed in the first half of this year.”

With regard to the FDA, he said while the delay was not ideal, it was, “a good thing the FDA haven’t come back with any problems and haven’t shut the door.”

Schmid said his company had expected the delay because its contact with the FDA had indicated the deadline would not be met.

Approval pathways

Marc Ullman of Ullman, Shapiro & Ullman postulated that the delay was down to the FDA’s unwillingness to acknowledge that a nutrient could indeed switch from drug to dietary supplement status.

“The 1994 Dietary Supplements Health and Education Act created a clear pathway to market for substances like homotaurine,” he said.

“We remain hopeful that our efforts to push through these bureaucratic barriers on a variety of levels will finally lead to FDA acknowledging that a well-researched, safe, beneficial substance like homotaurine belongs on the market.”

“The Agency should be taking all steps possible to encourage companies like OVOS rather than erecting senseless hurdles that seem designed solely to frustrate and discourage the entry of well-researched products into the supplement market.”

Drug history

Ovos withdrew its application for approval of homotaurine as an Investigational New Drug Application (NDI) in May, 2008, after a Phase III trial, that tested the ingredient in 1,052 Alzheimer’s disease patients above the age of 50, failed to meet drug requirements.

The firm said its trials on the ingredient have demonstrated that after 18 months it preserved hippocampus volume by 68 percent compared to placebo and improved cognitive performance by 33 percent compared to placebo after one year.

The Federal Food Drug and Cosmetic Act (FDCA) seeks to protect the pharmaceutical market by stating that a substance cannot be marketed as a dietary supplement if it has been authorized for investigation as a new drug.