In September 2019, the FDA sent warning letters to three tattoo ink manufacturers about microbial contamination in the products. The agency conducted microbial analysis of tattoo ink samples collected from customers around the country.

The warning letters noted that the tattoo inks contained pathogens and microorganisms that rendered them adulterated under the Federal Food Drug & Cosmetic Act (FFDCA). The agency regulates tattoo inks as “cosmetics” under the FFDCA because the inks are introduced into the body to “promot[e] attractiveness” or “alter[] the appearance.” See 21 U.S.C. § 321(i).
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With increasing attention to lawsuits based on “natural” claims, some litigants have also challenged claims that products were “100% pure.”  Many suits have attempted to use findings of chemical or pesticide residue to attack a product’s marketing regarding its purity.

While the Food and Drug Administration is yet to provide clear guidance on the term

Consumers notice and are more likely to buy products that are marketed as Made in USA, but companies face significant legal risk, negative publicity, and decades of government oversight if they overstate the extent to which their products are made in the United States.

  • Companies marketing their products without qualification as Made in USA

Takeaways:

  1. Support any comparative claims and clearly disclose the basis of the comparison.
  2. Be specific about claims regarding products or components made in the United States.

Last month, the National Advertising Division (NAD), a self-regulatory body, recommended that Telebrands, Corp., discontinue certain advertising claims for the company’s Atomic Beam flashlight, including claims comparing its brightness

 

Takeaways:

  1. Health-related advertising claims must be supported by competent and reliable scientific evidence, generally consisting of human clinical trials that are methodologically sound and statistically significant to the 95% confidence level.
  2. Advertising claims must be clearly expressed as ingredient claims if the substantiation addresses only the efficacy of the ingredients in the product, not the product itself.


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The Federal Trade Commission (FTC) and the State of Maine recently delivered yet another “gut check” to businesses engaging in weight loss advertising, Map of Maineobtaining a $2 million dollar settlement against an advertising agency related to allegedly false claims. While challenges related to weight loss claims and related offers are all too familiar for brands, this settlement serves as a heavy reminder to ad agencies that they can also be held responsible for false advertising.

In its complaint against Marketing Architects Inc. (MAI), the FTC and Maine alleged that radio ads created and disseminated by MAI for its client, Direct Alternatives (the maker of Puranol, Pur-Hoodia Plus, PH Plus, Acai Fresh, AF Plus, and Final Trim) made a number of (1) false or unsubstantiated  weight loss claims; (2) false or inadequately-disclosed “free trial” claims; and (3) false testimonials or ads disguised as testimonials.
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