Warning Letter Wednesday Posts

When FDA asks for records, companies should generally comply or they can face warning letters. This year FDA has sent eight warning letters to OTC companies refusing to respond to ...

This company is a small manufacturing facility and storefront that is reminiscent of the companies I would order herbs from in the 1990s. Since then, herbal regulations have matured, but ...

Eight companies received warning letters for selling homeopathic and other eye-lubricating products. This signals the continued shift in FDA’s enforcement priorities towards homeopathics. Most of these companies were selling ophthalmic ...

This company received several observations for minor labeling issues, but the GMP-related observations and the website disease claims likely tipped the scale into a warning letter. This warning letter is ...

Amazon, Walmart, and four other companies were issued warning letters for distributing homeopathic products used to treat molluscum contagiosum, a viral skin condition most commonly occurring in children. This is the second ...

This Traditional Chinese Medicine (TCM) product company was cited for GMP violations and disease claims. This warning letter contains critical GMP and marketing lessons such as labeling, testing, and marketing ...

11 companies were cited for failing to provide FDA information on contaminant testing for glycerin, propylene glycol, and other ingredients. These ingredients are most commonly adulterated with diethylene glycol (DEG) ...

This is the tenth FDA delta 8 warning letter this year, which is an important reminder that delta 8 THC is still on FDA’s mind, especially when it’s sold in ...

Claims about animal products were cited in today’s warning letter. Most statements involve customer testimonials with biomarkers such as “kidney values,” and “liver count,” and some other disease statements. Animal ...

FDA recently issued its first kratom warning letter of the year to a company making opioid withdrawal and support claims. So far this year FDA has been quiet on kratom ...

FDA and FTC recently sent six joint warning letters to companies selling delta 8 products that were favorable to children. Thank you, FDA and FTC! These warning letters highlight some ...

There have been three YouTube-related supplement warning letters this year, which shows FDA is not slowing down with this enforcement trend. Since this is a US holiday, I will keep ...