Synergy Products, Inc. – FDA Warning Letter, Sep 10, 2024

The FDA issued a Warning Letter to Synergy Animal Products, located at 1681 Schubert Rd, Bethel, PA, following an inspection from September 5 to September 10, 2024. The letter highlights significant violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) concerning the marketing of adulterated and misbranded animal drugs. The products in question include Ex-Cell Countdown 7000, Natural Cow Herbal Support, Ex-Cell Somaticare, Superior Cow Cream, and Super Cow Udder Mint.

Key violations include the marketing of these products as unapproved new animal drugs, which is prohibited under section 301(a) of the FD&C Act. These products are deemed drugs because they are intended for diagnosing, curing, mitigating, treating, or preventing diseases in animals. Additionally, the products are misbranded under section 502(f)(1) due to inadequate labeling that lacks clear directions for use, making them unsafe for consumer use.

The company also failed to comply with drug manufacturer registration and listing requirements under sections 510(b) and (j) of the FD&C Act, leading to further misbranding under section 502(o). Furthermore, the inspection revealed non-compliance with the FDA’s Current Good Manufacturing Practice (CGMP) regulations, resulting in the products being classified as adulterated.

The FDA requires Synergy Animal Products to take corrective actions, including ceasing the distribution of these unapproved and misbranded drugs and ensuring compliance with labeling and manufacturing regulations. The company must address these issues promptly to avoid further regulatory action.