compliance

“These statements have not been evaluated by the Food and Drug Administration.”

If you’ve ever purchased a sports nutrition supplement or vitamin, chances are, you’ve seen this sentence. What does it mean? Should it concern you? In this blog, our Director of Compliance breaks down what you need to know and how BPI differs from other companies out there.

The last few years, the U.S. Food and Drug Administration (FDA) has stepped up monitoring of dietary supplements marketed for weight loss, sexual enhancement and muscle building. The FDA has found products in these categories are sometimes tainted with undeclared drug ingredients that can cause potential harm to consumers and as a result, have taken enforcement action against the companies selling these products.

BPI products are regulated as dietary supplements under the auspices of the Federal Food Drug and Cosmetic Act (“FDCA”) and therefore are subject to FDA oversight. Manufacturers and distributors of dietary supplements in the U.S. are required to comply with the FDA’s dietary supplement regulations, including registering with the FDA on a biennial basis as required by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. This law allows the FDA to take the necessary steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply. In addition, facilities that manufacture, pack, or hold dietary supplements and/or dietary ingredients must also comply with the Dietary Supplement (DS) CGMP rule in 21 CFR part 111 (the DS CGMP rule). The DS CGMP rule requires companies who manufacture, package, label, or hold a dietary supplement to establish procedures to ensure the quality of their product and to ensure that their product is packaged and labeled as specified in the master manufacturing record.

BPI is in good standing with the FDA’s registration requirements and ensures compliance with the DS CGMP rule by employing the services of a third party company to carry out an annual quality system audit of BPI and its contract manufacturers. This annual audit verifies all BPI products are manufactured, labeled, held and distributed according to federal regulations and BPI and its contract manufacturers are following their responsibilities under the DS CGMP rule. In fact, a recent audit found BPI’s quality management team was extremely responsive in adhering to regulatory guidelines and compliance requirements, and is qualified through training, education and experience in performing their assigned duties.

Unfortunately, many distributors of sports nutrition supplements do not invest the time and money it takes to be fully compliant with the DS CGMP rule. Cutting corners is still a common theme in the industry, jeopardizing product integrity and product safety and inviting closer scrutiny from the FDA. BPI’s third-party certification demonstrates the company is committed to delivering the highest quality products from start to finish.

Why? Because we want to help you reach your fitness goals, and in order to look and feel your best, you have to take the best.

Trust Your Supplements