Are you prepared for an FDA audit? Do you know what to say and, more importantly, what not to say to FDA inspectors? Read the Food, Drug & Cosmetic Act recently? Regulatory requirements in the natural products industry, especially those that involve good manufacturing practices (GMPs), are voluminous and confusing. An entrepreneur can't expect to run a business and maintain a scholarly understanding of the FDC Act at the same time.
New companies need regulatory help, says former FDAer Bill Frankos, PhD, now SVP of global products at supplements direct seller Herbalife. "Consultant" is not a four-letter word, especially when it comes to food regulations.