When is a Cosmetic Also a Drug?

Oct 12, 2021 | Cosmetics, Drugs

Did you know that products designed to clean and beautify that ALSO affect the structure or function of the human body must bear special labeling? Per FDA’s 21 USC 359, these combination cosmetic – OTC Drug products must comply with OTC drug monographs and bear “Drug...

Social Media Considerations for FDA Regulated Products

Sep 30, 2021 | Cannabis, Cosmetics, Dietary Supplements, Drugs, Foods, Issue of the Month, Medical Devices, Tobacco, Veterinary

By Susan Crane, Independent Advisor, OTC Drugs and Labeling Historically, it has been straightforward for the FDA to review and monitor labeling and advertising for products under their jurisdiction, particularly drugs and medical devices. However, the widespread use...

Did you know? Color Additives Must Have FDA Approval and (Sometimes) Batch Certification

Sep 1, 2021 | Cosmetics, Did You Know, Dietary Supplements, Drugs, Foods

Color additives for most FDA-regulated products (tobacco and some medical device products are exceptions) must be approved by FDA and listed in the Code of Federal Regulations. If a color additive isn’t listed, its approval must be petitioned and approved by FDA prior...

Is it a Drug or Cosmetic? EAS Podcast hosted by CPhI

Aug 17, 2021 | Cosmetics

As more and more companies operating in the pharmaceutical space are moving into cosmetics, the temptation is to think that life will be much easier from a regulatory and compliance perspective. However, while it is true that pharmaceuticals are more heavily...

Meet Our Cosmetics Team

Jun 24, 2021 | Cosmetics

Did you know the EAS Cosmetics Team includes former FDA and high-level industry? From colors to claims, from formulation to safety, our experts can answer any manufacturing and regulatory challenge you may have. Stay in compliance with the FD&C Act. Trust EAS!...

The Cosmetic-Drug Conundrum

Dec 16, 2020 | Cosmetics

The subtle differences between allowable cosmetics claims and those crossing the line into drug products is tricky. The wrong claims can cause a cosmetic product to be misbranded attracting unwanted FDA attention. Once some of your marketing claims are under review,...