FDA Law

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Curated News:

November 1, 2018: FDA: Publishes final guidance on Nutrition and Supplement Fact Labels.

September 21, 2018: FDA: Guidance on Qualified Facility Exemptions.

September 12: 2018: FDA enforcement report.

August 21, 2018: FDA: Update of Guidance for Food Facility Registrations with Q&A.

July 16, 2018: CA SECOND APPELLATE DISTRICT: 3-Judge Appeals Court holds that Proposition 65 (re: alleged acrylimide in POST cereals) was preempted by the FDA’s nutrition labeling requirements.

May 18, 2018: FDA: New-supplier evaluation tool added to FMVS Evaluation Resources page.

April 16, 2018: Montana U.S. District Court sentences Canadian online pharmacy to pay $35 million, 6 months house arrest, and 5 years probation. The case involved undervaluation of the drugs to avoid filing commercial entries, drop-shippers, mis-handled drugs, and counterfeit anti-cancer drugs that lacked an active ingredient.

January 25, 2018:  FDA's Draft Guidance: Supply Chain Program:  FSVP Fact Sheet.

September 18, 2016: Nevada: Online colored-contact lens business pleads guilty to counterfeitting and misbranding.

The FDA administers more than 200 federal laws that applies to approximately $1 trillion dollars in products annually. While this web of regulations is designed to protect the American public, these laws can be confusing, and at times the standards and requirements can be unclear to industry. Companies caught up in FDA enforcement activity and investigations require knowledgeable counsel ready to step in to resolve these serious legal problems.

Several of the most important laws administered by the FDA include:

  • The Federal Food, Drug, and Cosmetic Act of 1938 which among other things, regulates new pharmaceuticals, provides various standards for food, and allows the FDA to conduct factory inspections.

  • The Kefauver-Harris Amendments of 1962 further strengthen the rules for drug safety and standards for drug efficacy.

  • The Medical Device Amendments of 1976 which requires safety and effectiveness safeguards as regards new devices.

Food Products

One mission of the FDA is to protect the public health by generally requiring that foods are safe, wholesome, sanitary and properly labeled.

The U.S. Department of Agriculture however holds jurisdiction over meat from livestock, poultry and some egg products.

Pharmaceuticals

The FDA ensures that human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective. The agency maintains an expansive compliance regime that regulates the pharmaceutical industry. Medical and advertising claims are also highly regulated.

The authority of the FDA should not be confused with the DEA which regulates controlled substances and drug-paraphernalia.

Cosmetics and Dietary Supplements

The FDA regulates cosmetics and dietary supplements to ensure that they are both safe and properly labeled. Medical and advertising claims are also highly regulated.

Medical Devices

Medical devices are also highly regulated. For example, foreign companies what manufacture medical devices (and/or products that emit radiation) must comply with applicable U.S. regulations before, during, and after importing into the U.S. or its territories. Also, medical devices that have not been approved or cleared in the U.S. are regulated by the export provisions of the FD&C Act. Medical and advertising claims are also highly regulated.