FDA Warning Letters

Products like Doweedos Delta-8 Edible Chips were cited in yesterday’s joint FDA/FTC warning letters. There were actually six warning letters sent in this enforcement action group, but for some reason, ...

This is a cautionary tale of how quality control, food safety oversight, and sanitation, even at one of the world’s largest companies, can go wrong. Salmonella was discovered at one ...

Are clinical studies really needed on finished dietary supplements? Here, I review a recent National Advertising Division (NAD) case on the topic. Full disclosure: I like NAD, and their cases ...

I love educating about enforcement trends and regulatory marketing compliance, and I’ve been writing this weekly post for almost three years. I have two small companies in the dietary supplement ...

This company received a warning letter for selling tianeptine—a substance deemed dangerous and inappropriate for dietary supplements according to FDA. Read more about FDA’s position here. In January FDA inspected this ...

Nutrient content claims can lead to litigation and are often cited in warning letters, although they are not typically the primary reason for a letter. Following all the rules can ...

Videos must disclose material connections when making sponsored content. Here, we learn more about when material connection is needed and what constitutes disclosure, especially when children’s advertising is involved. In ...

This NAD case shows that making “clinically proven” claims attracts the highest level of scrutiny. The National Advertising Division (NAD) has been paying close attention to skincare marketing claims, and ...

Warm greetings from 35,000 feet, as I am flying back from a 3-day whirlwind trip to participate in the Vitafoods Startup Award finals in Geneva. This company received a warning letter for ...

FDA issued a warning letter yesterday for Spanish language disease claims made on product labels and the company’s website. Examples of these claims include “cancer,” “antiviral,” and “arthritis.” Surprisingly, there ...

This NAD case is a good reminder of the importance of influencers properly disclosing material connections in the same manner that endorsement is made. For example, suppose there is an ...

There are three lessons in this Warning Letter Wednesday post. Labeling major allergens, avoiding label mix-ups, and hazard analyses are required for conventional food. The specific type of allergen is ...