Website claims and GMP violations continue to dominate FDA warning letters

FDA sent a warning letter to Yardley, PA-based High Performance Formulas, L.L.C.​ for claims on the company’s website that “establish that [the company’s] products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease”​.

Maryland-based From Fatigued to Fantastic, LLC​ also received a warning letter for language used on the company’s website http://www.endfatigue.com relating to products “promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. “​

North Carolina’s Nature’s Pearl Corporation​ also received a warning letter with similar language for anti-cancer effect claims on its website.

In FDA’s letter to Nature’s Pearl, the agency also stated: “Your website also makes the following statement: "Nature's Pearl™ has been certified by the FDA to be in Full Compliance under FDA 21 CFR 111." This statement is false and misleading under section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)) because FDA does not certify compliance with the dietary supplement current good manufacturing practices under 21 CFR Part 111.”​

Actions speak louder than words​

Florida-based SEI Pharmaceuticals, Inc.​ received a warning letter following an inspection of the company’s dietary supplement manufacturing facility in September 2011.

The agency’s inspectors reported violations of FDA's Current Good Manufacturing Practice (CGMP) regulations. “These violations cause the dietary supplements manufactured in your facility to be adulterated within the meaning of Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that these dietary supplements have been prepared, packed, or held under conditions that do not meet current good manufacturing practice requirements for dietary supplements.”

The company sent a written response to FDA in October 2011 to the FDA-483 presented at the conclusion of the inspection. However, FDA deemed that SEI’s response was inadequate on a number of points.

Commenting on the warning letter, the American Herbal Products Association (AHPA) said that the letter reminds industry that “a Form 483 response to FDA that says ‘we are going to fix it’ is not enough, FDA wants to be shown the fix. “​