Pharmaceuticals must meet certain standards for quality as established by the United States Pharmacopeia (or USP). The USP is a non-profit organization that works closely with the Food and Drug Administration (FDA), the pharmaceutical industry, and health care professionals to establish authoritative standards. These standards are enforceable by the FDA and the governments of more than 35 other countries, and are recognized worldwide as the hallmark of pharmaceutical manufacturing quality.
As you may have noticed, the following statement appears on many USANA product labels:
"Laboratory tested, quality guaranteed. Meets USP specifications for potency, uniformity, and disintegration where applicable."
USANA voluntarily adheres to a rigorous quality assurance program modeled after the pharmaceutical industry. This high standard of manufacturing separates USANA from many other dietary supplement companies.
USANA occasionally receive inquiries asking whether the FDA has audited USANA's facilities for Pharmaceutical GMP compliance. Unfortunately, the answer to this question is no. Because the FDA uses the Dietary Supplement Health and Education Act (DSHEA) as its legal guideline, our products - regardless of advanced voluntary quality control measures - can only be audited according to DSHEA rules, which currently require adherence to Dietary Supplement GMPs only.
However, please note that USANA products are considered over-the-counter drugs in Canada and Australia, and USANA continues to be audited to drug GMP equivalents by the regulatory organizations in these countries.
No comments:
Post a Comment