Who Regulates Food and Drug Manufacturing?
Food and drug manufacturers are subject to regulation by the United States Food and Drug Administration (FDA), the United States Department of Agriculture (USDA), or both. These agencies regulate the safety of most food and drugs that are distributed in the United States. Regulations are strict and violations carry serious consequences. Violations can result in criminal charges and civil fines that sometimes exceed one billion dollars.
FDA Regulation of Drug Manufacturing and Distribution
What is a drug?
FDA regulations define a “drug” as a substance that is meant for the “diagnosis, cure, mitigation, treatment, or prevention of disease.” Even with FDA approval for manufacture, a drug may only be marketed and promoted for the specific purposes approved by the FDA. For example, an FDA approved substance for treating headaches may not be marketed as a treatment for high blood pressure without FDA approval.
The FDA approval process for drugs is long, complex, and expensive, often taking no less than nine years to complete.
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Pre-clinical Phase. In the pre-clinical phase of approval, researchers subject the new drug to toxicology testing in animals to determine the appropriate dosage, frequency, and delivery method, as well as any toxic side effects. The pre-clinical phase takes about 30 months to complete.
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Clinical Research Phases. The drug then moves through three phases of human testing that require a total of about six years to complete, after which time you must file a formal application for approval with the FDA. The application package is long, sometimes requiring 100,000 pages or more. You may be asked to provide scientific evidence of the drug’s safety and effectiveness and to reply to repeated clarification requests. In Phase IV, the drug is marketed to the general public and its effects are studied and reported to the FDA prior to final approval.
USDA and FDA Regulation of Food Manufacturing and Distribution
FDA regulations apply to all food products involved in interstate commerce, with the exception of meat, poultry, and certain egg-based products, which are under the purview of the USDA. The vast majority of food products are subject to FDA regulation.
Unlike drugs, food products do not require FDA or USDA approval before they are produced, manufactured, or marketed. Nevertheless, manufacturers must register, keep accurate records, comply with extensive safety regulations, and submit to periodic inspections. The use of existing coloring or food additives does not require FDA or USDA approval, as long as they are used in a manner that is approved by USDA and FDA regulations.
If you intend to use a new coloring or food additive or use an existing coloring or additive in a new way, you will probably need to petition the USDA to issue a new regulation allowing this use. This process is similar to that of seeking FDA approval of a new drug, and approval can take months, or even years.
FAQ
Do vitamins and organic supplements qualify as drugs? Where is the line?
In most circumstances, dietary supplements are regulated as foods rather than drugs. However, they may not be exempted from certain FDA regulations, particularly those pertaining to foods. For example, while dietary supplements do not require prior approval by the FDA to be sold, the FDA may take action against dietary supplements that have been proven unsafe. If you plan to manufacture or sell vitamins and organic supplements, take care to consult an FDA lawyer about how to market and label your product to ensure that you are in compliance with FDA regulations.
How Priori Can Help
An experienced FDA lawyer can help you comply with FDA regulations pertaining to your food product or drug and can help you efficiently navigate the extensive and complex nature of FDA, USDA and state regulations of food products and drugs.