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.
Enclosed herein are comments on "Guidance for Industry; Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request", published as Draft Guidance.
We support the Agency's proposed decision to allow sunscreen products to be labeled with SPFs up to SPF 50+ and understand that higher SPF levels may be considered if supporting data are submitted to the Agency for review.
This Citizen Petition requests the Commissioner of Food and Drugs to take the following action with respect to the Final Monograph for OTC Sunscreen Drug Products.
The Personal Care Products Council and CHPA write in response to the proposed rule from FDA regarding sunscreen drug products for OTC human use. We write to request that the following sunscreen active ingredients be deferred from inclusion in the final rule.
Comments submitted by the Consumer Healthcare Products Association and the Personal Care Products Council regarding draft guidance for industry on enforcement policy for OTC sunscreen drug products marketed without an approved application.
As many dietary supplement products are being marketed as containing cannabidiol (CBD), CHPA has an interest in this subject and we presented oral comments at FDA’s May 31, 2019, public hearing. These written comments supplement our oral remarks.
CHPA has reviewed the findings of the meeting of the World Health Organization Expert Committee on Drug Dependence. CHPA agrees with the Committee's recommendations.
