Birkdale Medicinals LLC – FDA Warning Letter

On March 20, 2013, the FDA issued a Warning Letter to Birkdale Medicinals LLC, following a January 2013 review of their website, birkmeds.com. The FDA determined that the products Immune Response 247, Cholestat, Silymarin 81, and LevelStat are promoted with therapeutic claims that classify them as unapproved new drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act).

Specific claims cited include Immune Response 247 for cancer, asthma, inflammation, and tumor cell prevention, and personal testimonials for triglyceride reduction. Cholestat was promoted for controlling cholesterol buildup, preventing transportation to arteries, and reducing inflammation and plaque formation. Silymarin 81 was marketed for treating liver ailments like hepatitis, necroses, and cirrhosis. LevelStat claims included reducing cardiovascular complications of diabetes, slowing diabetic neuropathy, and lowering blood glucose, cholesterol, and triglycerides in Type 2 diabetes patients.

These products are not generally recognized as safe and effective for their intended uses, making them "new drugs" requiring prior FDA approval under section 505(a) of the Act. Their introduction into interstate commerce without approval violates section 301(d). Furthermore, the products are deemed misbranded under section 502(f)(1) because they address conditions not amenable to self-diagnosis and