Submissions

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.

Letter to Drs. Femia and Santos regarding multiple active ingredient product monographs.

Our member companies generally support the recommendations found in the guidance but have concerns about the scope of hardness measurements and maximum break strength value.

CHPA appreciates the opportunity to provide the National Osteoporosis Foundation with comments on their recently released "Position Statement on Calcium and Cardiovascular Disease" as well as the Evidence Report on which it is based.

While the monograph system has served our nation well, it has become cumbersome and outdated and needs to be modernized.

CHPA comments on the Agency’s review and action on OTC time and extent applications. This proposed rule would supplement the time and extent application process for OTC drugs by establishing timelines and performance metrics for the Agency’s review of non-sunscreen TEAs.

CHPA appreciates the opportunity to provide information relevant to use of the term “natural” in food labeling, and believes that a formal definition will help to reduce consumer confusion and provide clarity to manufacturers and marketers making claims relying upon such a definition.

These comments are submitted on behalf of CHPA in response to the National Institutes of Health notice entitled, “Nominations to the Report on Carcinogens and Office of Health Assessment and Translation; Request for Information”.

In general, CHPA supports FDA's intent to harmonize the requirements for Rx and OTC products and make them consistent with long-standing Agency policy.