Dietary Supplements

CHPA respectfully submits comments to the Commission notice regarding public interest issues raised by Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland Ltd. (“Amarin”) in its Complaint concerning Omega-3 (ω-3) products.

On behalf of the CHPA Dietary Supplements Committee, we are writing to express our concern with the recent decision by the Joint Committee to include certain elements of 21 CFR 117 within the consensus-based standard for dietary supplements.

Herein CHPA provides comments on several questions from the U.S. Department of Agriculture’s Agricultural Marketing Service regarding the establishment of a National Bioengineered Food Disclosure Standard.

CHPA appreciates this opportunity to provide comments on FDA Guidance detailing the agency’s process for evaluating data on the beneficial physiological effects of isolated or synthetic non-digestible carbohydrates.

CHPA believes that FDA’s revised 2016 Draft Guidance is an important step in helping to improve manufacturer understanding of, and compliance with, the new dietary ingredient notification requirement in Section 413 of the Federal Food, Drug, and Cosmetic Act.

CHPA appreciates the opportunity to provide comments on this matter. While none of our dietary supplement member companies currently market products containing vinpocetine, we have an interest in the subject matter and wish to provide our comments.

These comments are directed broadly towards three of the four goals identified by ODS.