Submissions

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.

We are supportive of the International Pharmaceutical Excipient Council of The Americas' recommendations detailed in their correspondence that USP remove references to dietary supplements and their ingredients.

Letter regarding modernization of the USP compendia for OTC medicines. CHPA supports improving the compendial test methods and establishing product standards for safety.

Herein, CHPA provides comments on Citizen Petition FDA-2017-P-27331 which requests the addition of a warning to labeling for all OTC drug products labeled to relieve or prevent heartburn associated with reflux disease, acid indigestion, and sour stomach noting that these products do not eliminate the risk of esophageal cancer.

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 the opportunity to provide our comments to the EPA regarding the Executive order, "Enforcing the Regulatory Reform Agenda".

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CHPA believes that FDA’s revised 2016 Draft Guidance is an important step in helping to improve manufacturer understanding of, and compliance with, the new dietary ingredient notification requirement in Section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 submits the following comments to the U.S. Office of Budget and Management (OMB) in response to a request for public input on a draft memorandum titled “Information Technology Modernization Initiative.”

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.