USANA receives FDA registration to manufacture OTC drugs

USANA Health Sciences, Inc. (NYSE: USNA) today announced it has obtained the U.S. Food and Drug Administration's "Drug Establishment Registration," allowing the company to manufacture over-the-counter (OTC) drugs and holding it to a standard well above what is required of a dietary supplement manufacturer.  While nutritional companies in the United States are not expected to follow pharmaceutical Good Manufacturing Practices (GMPs), USANA believed it was an important, logical step to acquire government registration proving their long-standing commitment to producing the highest quality products.

USANA manufactures over 90% of its products in-house, including all of its tableted nutritional supplements.  As an FDA-registered facility, USANA now has the ability to manufacture OTC drugs as well.  All products manufactured under this license will be subject to very rigorous FDA drug manufacturing GMP guidelines going well beyond those required to manufacture nutritional supplements.  

"Few companies voluntarily submit themselves to increased scrutiny, but since we operate in 15 countries including Australia, where dietary supplements are highly regulated by the Therapeutic Goods Administration (TGA), our base manufacturing standards are extremely high," says USANA Chief Executive Officer, Dave Wentz. "So while obtaining FDA registration won't affect our day-to-day operations, it will help further assure our users of the quality of our products."

For many years USANA has voluntarily modeled our production on pharmaceutical GMPs and consistently obtained third-party certification as a way to ensure the safety and efficacy of its nutritional products.  "We encourage consumers to check their supplement company's FDA registration status online and to make sure their supplements are NSF-certified and meet United States Pharmacopeia (USP) standards and specifications," says USANA Vice President of International Operations, Jim Brown.

Independent testing is an important way for companies to demonstrate the legitimacy of their claims.  A recent ConsumerLab.com study showed that 1 in 3 vitamins are improperly labeled -- typically because the product did not contain the amount of nutrients claimed in the label.

"We regularly submit our products for independent testing and diligently maintain our third-party certifications," says USANA Executive Director of Research and Development, Dr. John Cuomo. "It's why we have so many loyal users, including several hundred Olympic and professional athletes. Nearly 20 years in business and we've never had to issue a recall."