Product catalogs are considered extensions of the label
Remove high-risk claims in all marketing materials
Claims made in product catalogs are considered marketing.
This warning letter includes claims made on product labels, catalogs, newsletters, and brochures. This is a good reminder that anything used to sell a product is considered an extension of the label and, therefore, should be compliant. Here is a video about this.
🔷This timeline is interesting here. The company was inspected in June 2021, before, during, and after a recall for undeclared soy allergens. FDA then reviewed this company's website in February 2022, which is the basis for most of the items in this warning letter. This is a trend, as last week's WLW also talks about an FDA inspection that leads to a website review and a warning letter.
👉This is a good reminder for companies to clean up their websites before/during/after GMP inspections, as a complete website compliance clean-up may have prevented this letter.
From the warning letter.
➡️From the product catalog on your website,
On page 13: “Enzymes Plus: … This formula uses specialized enzymes that helps the body break down excess protein on scar tissue and fibrin in the blood vessels and internal organs. It also seems to help remove the protective protein coating on tumors, cancers, and parasites, helping the body render viruses and bacteria inert. This blend is combined with Magnesium (a natural blood thinner) and B-6 that the body uses to help lower Blood Pressure and dissolve blood clots.”
👉Read the full warning letter here.
👉👉Join my Warning Letter Wednesday group.
Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.