FDA Law
The FDA administers more than 200 federal laws that apply to approximately $1 trillion dollars in products annually, including most foods, drugs, pharmaceuticals and medical devices. While the web of regulatory law is designed to protect the American public, these laws can be confusing, and at times unclear or contradictory. Companies caught up in FDA-related compliance issues find knowledgeable counsel a key in resolving these types of 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 pharmaceuticals, provides standards for food products, and provides the FDA authority to exercise oversight, and conduction inspections and detentions.
The Kefauver-Harris Amendments of 1962 further strengthen the rules for drug safety and standards for drug efficacy.
The Medical Device Amendments of 1976 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 for example, “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.
Curated News:
October 6, 2020: FDA: Facility registration renewal: All facilities that manufacture, process, pack, or store food for U.S. consumption must renew their facility registrations between October 1st and December 31st, 2020.
August 5, 2020: AMS: Proposal: Strengthening Organic Enforcement.
March 25, 2020: FDA Emergency Use Authorizations for medical devices.
March 23, 2020: COVID: Summary of FDA Guidance for COVID medical supplies from the LACBFA.
March 20, 2020: FDA Information Page on N95 Masks and Respirators.
March 20, 2020: FDA Medical Devices Page.
March 20, 2020: NIOSH N95 Page.
July 18, 2019: DOJ: Seafood Processor Pleads Guilty to Selling Foreign Crab Meat Falsely Labeled as Blue Crab from USA
June 10, 2019: Guidance: premarket tobacco product applications for electronic nicotine delivery systems (ENDS).
May 17, 2019: FDA: FSMA Technical Assistance Network (TAN) POPULAR TOPICS (including updates as to produce safety regulations).
April 2, 2019: USDA: Translation of China’s Food Safety standard: GAIN Report Number:CH 19010.
April 2, 2019: CBP: Instructions for CBMA (Craft Beverage Modernization and Tax Reform Act of 2017) Duty Refund claims.
January 28, 2019: EU: Council Decision 2019/136: Wine labeling certificates (Japan to EU).
December 16, 2018: FDA: Full FSVP enforcement to begin in FY 19.
December 13, 2018: DOJ: Dietary supplement ingredient importers arrested in connection with large-scale smuggling and money laundering scheme.
December 3, 2018: CBP: CSMS #18-000708: Importer’s can claim favorable duties for 12%-14% AVB wines.
November 1, 2018: FDA: Publishes final guidance on Nutrition and Supplement Fact Labels.
October 16, 2018, CBP: CSMS message # 18-000609: CBMA (Craft Beverages) procedures and requirements regarding implementation.
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.