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Oct 8, 2024 | 
supplysidesj.com | Asa Waldstein
Being able to substantiate claims has never been more important. The Federal Trade Commission is increasingly more focused on product substantiation, as highlighted by the publication of its 2022 Health Product Compliance Guidance and the 650+ Notice of Penalty Offenses it sent to health product companies last year.
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Oct 3, 2024 | 
supplysidesj.com | Asa Waldstein
In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters impacting manufacturers and marketers of dietary supplements. At a GlanceMinor label violations, such as fact panel line thickness, continue to be cited in warning letters. A NAD case involving a popular children's YouTube channel highlighted the complexities and need for material disclosure. FDA warning letters underscore that elaborating on studies or posting about them on social media can be problematic.
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Oct 2, 2024 | 
supplysidesj.com | Asa Waldstein
Asa WaldsteinAsa Waldstein is a certified clinical herbalist and a 20-year dietary supplement executive who has helped oversee three FDA inspections with no Form 483s. Waldstein is principal of the consulting company Supplement Advisory Group, a boutique group focusing on marketing risk analysis and practical marketing solutions for the web and social media.
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Apr 5, 2024 | 
naturalproductsinsider.com | Asa Waldstein
Dietary supplement consultant Asa Waldstein reviews regulatory trends over the last quarter in his FDA warning letter roundup column. Each quarter, I provide updates on notable FDA warning letters. Understanding enforcement trends is essential for being a savvy marketer, regulatory affairs professional and dietary supplement executive. Have you wondered why FDA issues warning letters to certain companies and not others?
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Jan 4, 2024 | 
naturalproductsinsider.com | Hank Schultz |Josh Long |Asa Waldstein
Yesterday, as I read the 12-page letter from Metro International Biotech to the Food and Drug Administration concerning nicotinamide mononucleotide (NMN), it occurred to me that I was developing a headache from the legal mumbo jumbo. The basic premise of the letter was simple: FDA is correct in its determination that NMN—a popular healthy aging ingredient—cannot be marketed in dietary supplements in the United States.
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Jan 3, 2024 | 
naturalproductsinsider.com | Hank Schultz |Josh Long |Asa Waldstein
As we enter 2024, here’s a roundup of some of the top stories of the past year. In October, content director Todd Runestad took a look at seven trends revealed by SPINS sales data. The sleep, eye health and sports nutrition categories were all up. Protein sales continued to soar while there was a changing of the guard in the top-selling joint health ingredients.
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Jan 3, 2024 | 
naturalproductsinsider.com | Hank Schultz |Josh Long |Asa Waldstein
A clinical-stage pharmaceutical company that has been investigating the use of nicotinamide mononucleotide (NMN) to treat medical conditions, including Alzheimer’s, has requested the Food and Drug Administration uphold its determination that the ingredient is excluded from the definition of a dietary supplement product and cannot be marketed in such products.
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Jan 3, 2024 | 
naturalproductsinsider.com | Hank Schultz |Asa Waldstein
The American Kratom Association has accused the Tampa Bay Times of accepting funds from trial lawyers to pay for its recent series on overdose deaths in Florida linked to the botanical. The newspaper’s editor has denied the charges. Last week, AKA’s senior fellow on public policy Mac Haddow sent an email to industry sources, claiming the investigation was funded at least partially by contributions made by trial lawyers who have been suing kratom manufacturers and marketers.
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Jan 2, 2024 | 
naturalproductsinsider.com | Hank Schultz |Asa Waldstein |Rachel French
Amazon, the No. 1 retailer of supplements ahead of heavyweight brick-and-mortar chains like Walmart and Target, continues to hold its ground, raking in $12.6 billion in total vitamin, minerals and supplements (VMS) sales for the 12 months ending in August 2023, according to data from SPINS/ClearCut Analytics. Amazon’s VMS dollar sales grew 14.6% compared to the year prior, and VMS unit sales exceeded 472 million over the last 12 months and grew 8.5% compared to the year prior, the data show.
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Jan 2, 2024 | 
naturalproductsinsider.com | Hank Schultz |Asa Waldstein
Each quarter, I provide updates on notable FDA warning letters. Understanding enforcement trends is essential for being a savvy marketer, regulatory affairs professional and dietary supplement executive. Have you wondered why FDA issues warning letters to certain companies and not others? FDA likes to make examples of companies not following the rules in areas they want to focus on, many of which I review here.
