The submission for the brain health nutrient was made by Bellus Health-owned Ovos Natural Health in mid-2009 after its initial strategy to take it down the drug route fell short at the clinical trial phase – so the FDA has deliberated on the matter for 18 months.
If it had OK’d homotaurine the FDA would have had to conceive new rules under the Food, Drugs and Cosmetics Act (FDCA) to deal with the drug-supplement switch, but its verdict that the compound did not qualify for consideration as an NDI because it was not deemed an amino acid and because it was synthetically manufactured, meant the agency did not confront that issue, something the Natural Product Association’s scientific and regulatory VP Dr Cara Welch noted was, “handy for them”.
Here, a very disappointed Marc Ullman, the attorney who lodged the petition on behalf of Ovos, shares his thoughts on a verdict that may be bad news for parties other than Bellus Health and the new owner of Ovos, Advanced Orthomolecular Research.
[NI-USA] Is there anything new/significant in the FDA highlighting that the homotaurine compound in question was synthetically made and therefore not authorised as a dietary supplement under section 201(ff)(1) of the FDCA?
[MU] “It’s not new. FDA has taken this position before, the first time I believe was in connection with the addition of ephedrineHCL to ephedra dietary supplements. The distinction there is that I do not believe that the HCL salt is found in nature. In any event, I can find no basis in DSHEA for FDA to take this position generally, or in connection with homotaurine.
The law states that a dietary supplement can be “a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E);”(FDCA Section 201(ff)(1)(F). The homotaurine offered as an NDI by OVOS is a constituent of red algae. FDA while acknowledging that OVOS’ homotaurine could be a dietary ingredient if it was extracted from red algae, ignores the fact that it is a constituent of red algae. OVOS’ homotaurine is nature identical - it is chemically the same as red algae extract. I do not see any basis in law for what FDA is doing.”
[NI-USA] Could it herald a crackdown on other synthetically made botanical versions already on the market (e.g. synthetic geranium extracts)?
[MU] “I believe that the difference here is that the synthetically made ‘botanicals’ you are referring to may not be nature identical – they may be salts of the chemical entity found in nature.”
[NI-USA] Obviously you are disappointed by the opinion, but does its logic in any way strike you as bizarre?
[MU] "The FDA’s response to the Petition signals the Agency’s desire to (a) do what it can to limit what can be considered a dietary ingredient and (b) delivers a message to industry that it intends to make the 201(ff)(3)(b)(ii) pathway to market as difficult as possible. This adds up to an effort to discourage companies that have spent millions of dollars on research pursuant to an Investigational New Drug [IND – which Bellus/Ovos did] from trying to take their product to market for use in dietary supplements."
The FDA was not available for comment at the time of publication.