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FDA Claims Warnings Strike Again: Using Terms ‘Botox-like’… and more, via Cosmetics & Toiletries

August 10, 2016 By: Nicole Urbanowicz

PART II

Once again, U.S. regulators are cracking down on beauty companies that have crossed over into unapproved drug claim territory based on how they are promoting their products online.

The U.S. Food and Drug Administration found out that claims on two companies’ websites established that the products are drugs under sections 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B) and/or 21 U.S.C. § 321(g)(1)(C)] “because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or articles intended to affect the structure or any function of the human body.”

In a letter to Sircuit Cosmeceuticals, the FDA said website claims associated with REVELATION intensive anti-wrinkle eye serum, EYE TECH anti-wrinkle eye emulsion, ORAIA anti-aging intensive regeneration complex, and SUGGAH + anti-aging lip plump treatment violated the Federal Food, Drug and Cosmetic Act.

Violation: ‘… resembles the effects of Botox’

New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective and said the company’s claims cross over into the drug territory.

Read more…

PART I

Watch those cosmetics claims. The U.S. Food and Drug Administration (FDA) has issued a warning to a company about some of its product label and website claims that it said provides evidence the products are intended for use as drugs.

Are Your Cosmetics Intended for Use as Drugs?

The FDA issued a warning letter to Reviva Labs Inc. saying  claims on its product labels and website indicate that the Nasolabial Fold Multi-Peptide Cream, Glycolic Acid Oily Skin Daytime Light Cream Moisturizer, Skin Lightener For Day Fade Cream, DMAE Firming Fluid, Collagen Regeneration Cream, Lighten & Brighten Dark Spot Serum, Spider Vein & Rosacea Day Cream W/Vitamin P, and Vitamin K Cream products are drugs under section 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act because they are intended for use in the cure, mitigation, treatment, or prevention of disease and/or are intended to affect the structure or any function of the human body.

Extraction bas site