FDA Warning Letters

The product in this warning letter contains hordenine HCL, which FDA does not consider a dietary ingredient. Adding this into a supplement makes it an adulterated product which is a ...

Learning about compliance is fun, and today’s Warning Letter Wednesday has critical teaching opportunities for marketing and GMP compliance. This is yet another example of a company being inspected by ...

Most of us have heard about the recent FTC notice of penalty offense sent to ~670 companies. To those not on the list, mazel tov. This FTC action puts these ...

Testing for known contaminants is an essential part of GMPs. This company was cited for not conducting proper identification and known contaminant testing on glycerin, an ingredient used in its ...

This company received 483s for GMP violations relating to testing methods and specifications.  They were inspected in late 2021 and early 2022 and sent FDA five 483 responses last year. ...

More overt COVID claims are cited in this warning letter. We all know that making COVID claims about supplements is wrong, but let’s explore key learning lessons you can apply ...

This warning letter involves claims made in catalogs and product labels collected during a GMP inspection. Over 500 supplement executives and regulatory professionals receive Warning Letter Wednesday by email. Sign ...

Digestive system claims like Crohn’s and IBS occasionally show up in warning. Diseases like Crohn’s Disease or syndromes like Irritable Bowel Syndrome should be removed, or if accurate, replaced with ...

Warning Letter Wednesday primarily focuses on FDA-related enforcement, but occasionally I review interesting FTC actions. Today’s #WarningLetterWednesday highlights three FTC cases against distributors of doTerra essential oils and supplements. doTerra ...

This letter primarily cites digestive ailment claims such as Irritable Bowel Syndrome (IBS) and heart health claims such as “lowers cholesterol.” While these types of statements should be avoided, they ...

Claims made about animal products seem to have a lower tolerated “acceptance level” than human products. This is a friendly reminder to take another look at your animal product marketing ...

FDA continues to issue more warning letters to companies that do not adequately respond to 483 violations. The violations and 483 responses provide excellent learning opportunities. Here are some key ...