FDA rejects homotaurine NDI bid; finds it is not an amino acid
In handing its belated response to Ovos’ new dietary ingredient (NDI) petition that was lodged more than 18 months ago, FDA issued a seven-page document detailing why homotaurine is not an amino acid and did not fit any other dietary ingredient category as listed under section 201(ff)(1) of the Food, Drugs and Cosmetics Act (FDCA).
FDA said that for the purposes of that section of the FDCA, “the term ‘amino acid’ refers to an alpha-amino carboxylic acid used as a constituent of proteins or peptides. Homotaurine is a gamma-amino sulfonic acid. It is not an alpha-amino carboxylic acid or a constituent of proteins.”
It therefore could not be considered for NDI status, FDA said, adding that the fact Ovos's homotaurine form was synthetically manufactured also disqualified it.
Ovos was sold by Bellus Health to Advanced Orthomolecular Research at the end of 2010. The two companies negotiated an exclusive license and supply agreement for Vivimind, the proprietary version of homotaurine.
Responding to the FDA decision, Bellus-Ovos’s attorney Marc Ullman questioned the FDA’s amino acid classification criteria.
“Obviously we are extremely disappointed by the FDA's decision,” he told NutraIngredients-USA.com from the Focus on the Future Conference in Arizona.
“When I look at the Dietary Supplements and Health Education Act (DSHEA), I see the words ‘amino acid’, I don't see the words ‘some amino acids’.”
Bellus Health itself was not available for comment at the time of publication but Ullman said it had instructed him and other experts to, “review the validity of FDA's hyper-technical argument”.
He said the company and his team were “particularly troubled” by the fact that homotaurine had previously been classified as an amino acid when the compound had been considered and approved for use by the FDA in a drug called Campral.
Commenting on the decision, Ricardo Carvajal, from the Washington DC office of legal firm, Hyman, Phelps & McNamara, observed on a blog: “The response also suggests that FDA can be expected to closely scrutinize the applicability of the definition of ‘dietary supplement’ to synthetic substances that are not already part of the food supply.”
This distinction was noted in a NutraIngredients-USA story this week about synthetic versions of geranium extracts.
To read that story click here.
Bellus/Ovos was trying to break new ground with its NDI petition by becoming the first firm to have an ingredient switched from drug to supplement status after its initial efforts to have the ingredient win drug approval fell short at the clinical trial stage. If the application had been accepted, the FDA would have been required to "promulgate regulations" to accommodate the drug-supplement shift.
Vivimind is approved for use in dietary supplements in Italy and Spain and Health Canada has approved it under its Natural Health Products Directorate.
Ovos’s original petition can be found here .
The 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 “unless the Secretary, in the Secretary’s discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this Act”.