FDA Warning Letter Cites Toothpaste Maker for CGMP and Color Additive Violations

The FDA has issued a warning letter to Pritam International Private Limited, a contract manufacturer in Haridwar, India that produces over the counter toothpaste and other drug products for the U.S. market. According to the FDA warning letter, an inspection conducted in June 2026 and a related records review turned up significant violations of Current Good Manufacturing Practice regulations under 21 CFR parts 210 and 211.

The most notable finding involves the company's "Brush Buddies Cookies 'n Cream Ice Cream Flavored Toothpaste," which the agency says contains Ext. D&C Red No. 10, a color additive whose certification was cancelled in 1966 due to insufficient safety data. The FDA states that any use of this additive after that date renders a drug product adulterated under the FD&C Act, a concern made sharper by the fact that the toothpaste is marketed to children.

The letter also cites incomplete laboratory records, noting the firm lacked original data showing compliance with its own testing specifications. FDA has asked the company to conduct a full risk assessment of its formulations and color additive sourcing.

This case is a reminder that manufacturing oversight, not just ingredient research, determines whether a finished product is safe to use.

This article is for education only. It is not medical advice. Compounds discussed here are sold for research purposes. Talk to a licensed clinician before making health decisions.