FDA indecision muddies drug/supplement borderline
The FDA is eight months late responding to the petition lodged in mid-2009 by Canadian firm, Ovos Natural Health, which seeks to alter the status of its amino acid (homotaurine) after it became apparent clinical trial results were not going to meet pharma regulations.
Marc Ullman, from Ullman, Shapiro & Ullman, which represents Ovos, said the delay was causing commercial damage to Bellus Health-owned Ovos, a fact that had led it to consider legal action seeking “irreparable damages”.
“The only response we have had from the FDA is, ‘we are working on it’,” Ullman said. “And so a perfectly safe ingredient is being denied entry onto the biggest dietary supplements market in the world.”
Not yet ready
The fact the FDA is 'working on it' was confirmed in a January 25 letter written by FDAassistant commissionerfor legislation, Jeanne Ireland, to Congressman Dan Burton.
“An interested party may submit a Citizen Petition to the Agency requesting issuance of a regulation permitting a substance that had previously been approved or investigated under an IND [investigational new drug] as a drug or biologic to be a dietary supplement, and nothing has precluded such a submission at any time since DSHEA became law,” Ireland wrote.
“FDA is currently evaluating the first petition of this type, concerning homotaurine, which was previously the subject of an IND. FDA is actively working on responding to this petition but is not yet ready to announce a decision.”
The FDA was unavailable for comment at the time of publication.
The delay may be explained by the fact that it is the first petition of its kind, coupled with the ambiguity that exists around the interaction of DSHEA (Dietary Supplements and Health Education Act) and the Federal Food, Drug, and Cosmetic Act (FDCA).
Substantial Clinical Investigations
This ambiguity hinges on the fact that DSHEA’s definition of a dietary supplement excludes drugs and substances, “authorized for investigation as a new drug or biologic for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public.”
But in her letter Ireland sheds light on the problem when writing that, “even if a product would otherwise be excluded from the dietary supplement definition by this provision,” the door could be opened via a citizen’s petition.
There is also growing concern about the potential reclassification of nutritive substances as drugs if they are deemed to be have undergone, "substantial clinical investigation".
“FDA agrees that it would be helpful to clarify the Agency's interpretation,"of the interplay between DSHEA and new FDCA section 301(ll)/Food and Drug Administration Amendments Act section 912.
Ovos has a branded version of homotaurine called Vivimind that last year received approval from the Italian Ministry of Health to be marketed as a dietary supplement there.
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.
