Warning Letter Wednesday^® Posts

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 ...

Since the beginning of 2023, 11 warning letters have been issued for arthritis-related supplements and topical product claims. Here, I explore these warning letters, look at common trends, and share ...

FDA cited this company for selling a topical magnesium product that also contains ingredients like fulvic acid, vitamin B6, and MSM. Based on website claims FDA concluded the product was ...

Claims on social media can tip the scale to a warning letter. This warning letter is interesting. It includes topical products marketed as drugs, animal “drug” claims, and more, but ...

We can learn from others’ mistakes, and this warning letter outlines what to avoid when marketing herbal supplements. This company was inspected by FDA and received some 483s, but today, ...

This company was making claims related to sustainability, “clean ingredients,” and efficacy. This is a really interesting case that we can learn a lot from! The National Advertising Division (NAD) ...

Is major allergen labeling complicated? The answer is maybe sometimes, but it doesn’t have to be. Here, I review recent allergen labeling-related recalls and provide some helpful resource links. It ...

Distributors are responsible for the products they hold and distribute. Here, I review a recent warning letter where the company was cited for GMP and labeling issues, and there are ...

“Forgotten” social media posts from years ago are active marketing and are fair game for enforcement. Today, I’ll explore old social media warning letter citations that include retweeting, images, videos, ...