FDA Warning Letter

SITUATION

A company received a FDA Warning Letter, giving the fifteen (5) business days to respond with a plan for bringing their products into compliance.

PROBLEM

The client’s website and labels contained claims that violated the Federal Food, Drug & Cosmetic Act, causing their products to be deemed misbranded and adulterated under FDA regulations. The FDA warned that unless adequate corrective action was taken, the FDA would pursue further enforcement action.

SOLUTION

We worked with the company to resolve the underlying FDA compliance issues, including developing FDA compliant labeling. This included both a website review and label reviews to help remove claims that violated FDA regulations and caused the products to be deemed misbranded and adulterated. Additionally, we communicated directly with FDA on the company’s behalf to respond to the warning letter in a way that resolved the matter without additional FDA enforcement action.

BENEFITS

The company’s products were now marketed as they initially intended, as food products that do not require FDA approval, since all labeling, including the website claims and labels complied with FDA regulations. Additionally, the FDA halted all enforcement action against the company because all matters were appropriately addressed in the response to the warning letter


For more information, contact Katherine Giannamore at 305-780-1544 or [email protected].

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