The Food and Drug Administration (FDA) regulates more than a trillion dollars worth of consumer goods – about twenty-five percent of the total U.S. consumer expenditures. This amount includes half of a billion in food sales, over a quarter of a trillion in drugs, almost a hundred billion in cosmetics, and twenty-five billion in vitamins and dietary supplements. Consistent with the FDA’s evolution from its humble beginnings in 1862 as a laboratory, its influence is likely to grow in the future. Whether it is assistance with your company’s biometrics or dietary supplements, to name a couple, or serve as a “party not affiliated with your company” to “test the waters” prior to asking the formal questions you need answered – we are there. Remember: “Never ask a bureaucrat (or political appointee) a question, unless you know the answer ahead of time – then structure the question to get the answer you need.”
Besides the day-to-day involvement with our clients, our company’s founder has twenty-five years on a Congressionally mandated policy advisory for Chemicals, Pharmaceuticals, Health/Science Products and Services. Our staff has doctorates from top-tier Schools of Medicine and Regulatory Affairs Certifications.
- New Dietary Ingredient applications
- Generally Accepted and Safe (GRAS) designations
- Ensuring advertising compliance
- Responding to Warning Letters