Podcast - Made in the USA Claims
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Polsinelli Podcasts - The Latest on a Shift in Regulation in Dietary Supplements
PATIENT PRIVACY IN AN ERA OF SOCIAL MEDIA
A July 14, 2025 U.S. Food & Drug Administration (FDA) warning letter to a prominent wellness product and services company offers a blunt reminder that medical device requirements cannot be waived or overlooked merely because...more
There is nothing new about companies providing platforms for other companies to sell their wares. That is, after all, exactly what supermarkets do, and TV and radio networks have long run ads for other companies. The rise of...more
The Made in the USA label carries significant marketing weight, especially in today’s political landscape, but it also comes with legal risks. Federal regulators and class action attorneys are scrutinizing origin claims,...more
With the compliance process for the Extended Producer Responsibility (“EPR”) programs for packaging, paper, and food service ware in full swing in Oregon and fast approaching in Colorado and California, “producer” companies...more
There is an ever-increasing number of consumers who are following a vegetarian or even vegan diet – and with this comes a wide range of vegetarian and vegan foods that can now be found in many supermarkets and restaurants....more
On August 29, 2024, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued an untitled letter to AbbVie, Inc. (AbbVie) regarding a promotional, direct-to-consumer (DTC) television...more
Effective September 15, 2024, the Connecticut Department of Consumer Protection (DCP) has announced a series of updates to its cannabis policies and procedures. These changes, spanning everything from lab testing to licensing...more
The final quarter of the year is the alcohol industry’s busiest period, accounting for approximately 70% of annual business. Many holiday-themed seasonal products are beginning to make their way to market, and it is important...more
Welcome to Nutter's Beverage Breakdown, a periodic legal update on noteworthy developments related to the alcohol beverage industry, including industry news, federal and state updates, and more. ...more
In early July the Staff of the Federal Trade Commission (FTC) issued new guidance on how to approach Made in USA claims. The agency says the new guidance will help businesses comply with its “all or virtually all” standard,...more
On July 8, 2024, the U.S. Food and Drug Administration (“FDA”) issued a new draft guidance for industry titled, Addressing Misinformation About Medical Devices and Prescription Drugs – Questions and Answers (hereafter,...more
On July 2, 2024, the Federal Trade Commission announced a “refreshed version” of the agency’s Complying with the Made in USA Standard guidance document. The refreshed guidance document includes, without limitation, updated...more
Dietary supplement industry leaders and regulators gathered in Salt Lake City in June to examine the current status of the Dietary Supplement Health and Education Act of 1994 (DSHEA), 30 years after that legal building block...more
A federal judge in California certified a class in an action alleging unfair competition and false advertising against Barilla America, Inc. (“Barilla”). In Sinatro v. Barilla America, Inc., No. 22-cv-03460-DMR, 2024 WL...more
The US Federal Trade Commission (FTC) is intensifying a crackdown on goods that are falsely or misleadingly marketed as “made in the USA.” Since the FTC, in its Made in USA Labeling Rule, 86 FR 27022 (July 14, 2021), 16 C.F.R...more
FDA recently issued a revised draft guidance titled Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products. This...more
On April 25, 2024, FDA published a revised draft guidance, Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products –...more
One of the worst-kept secrets among the plaintiffs’ bar is that claims like “pure” and “natural” on consumer-product labels can lead to class-action claims. Two recent court decisions denying motions to dismiss underscore the...more
ACI and CRN are excited to welcome you back to New York City this Spring for our 12th Legal, Regulatory & Compliance Forum on Dietary Supplements. Network and collaborate with over 150 industry stakeholders to explore how...more
At the National Advising Division (NAD), competitors will sometimes go for the brass ring, the big prize, the whole enchilada, and ask the NAD to recommend that an advertiser’s trademarked slogan or even the brand name be...more
Takeaway: Is a label clearly false or only ambiguously false? Where a label is ambiguous – and therefore subject to an interpretation that would render it deceptive – the ambiguity can be clarified by fine print. The fine...more
Huggies Diaper Evidence Not a Good "Fit" for #1 Claim, NAD Says - Huggies claimed its diapers were the #1 Best Fitting, a broad claim requiring broad evidence against the market—evidence that the National Advertising...more
Tractor maker Kubota North America Corporation will pay a $2 million civil penalty for falsely labeling its replacement parts as “Made in USA,” the largest civil penalty ever in a Federal Trade Commission (FTC) Made in USA...more
ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This...more
2nd Circuit Affirms Something's Off With Plaintiffs' Suit Against Nature's Bounty for its Fish Oil Claims - The Court of Appeals for the Second Circuit refused to revive a class action lawsuit alleging that Nature's Bounty...more