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Regulation of Dietary Supplements covers marketing, manufacturing, labeling, and advertising enforced by FDA and the Federal Trade Commission. See these FAQs to learn more.

FDA Announcement of a proposed safety-based Administrative Order that proposes to add a skin allergy warning to labeling requirements for acetaminophen-containing drug products.

Imposing Proposition 65 state-level requirements on chemicals actively regulated under federal purview risks duplicative warnings that undermine public trust in national safety determinations. Since the FDA derives allowable limits from the best available science, overriding federal risk-benefit guidelines with California-specific thresholds triggers unnecessary labeling not reflecting real-world exposures from routine product usage shown to be safe.

Pseudoephedrine (PSE) is a safe and effective active ingredient found in leading cold, allergy, and sinus medicines to provide congestion relief.

The Standardized Information on Dietary Ingredients (SIDI) Work Group has released three voluntary guidelines, intended to help the dietary supplement industry comply with cGMP regulations.

Learn about the OTC review process, drug monographs, and time and extent applications.

This proposed safety administrative order addresses the GRASE status of OTC oral health care drug products containing benzocaine alone or with phenol preparations labeled for anesthetic/analgesic indications (21 CFR 356).

While VOCs can have environmental impacts in aggregate, existing alternatives don’t always provide the consistent therapeutic results needed for OTC products relied upon by millions for. As such, any legislation aimed at further restricting pharmaceutical VOCs must carefully weigh potential unintended consequences on public health.

Informed Consumer Decision Making

Members of CHPA which market dietary supplements formally initiated a voluntary labeling program on March 22, 2000 which relates to the use of the following label statement on dietary supplement products.

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