Author

Fabiola Negron

Director of Food Safety

FDA or USDA: Who Regulates Dietary Supplements Containing Meat?

Apr 21, 2022

The U.S. Food and Drug Administration (FDA) works in conjunction with the U.S. Department of Agriculture (USDA) to regulate many food products distributed in the United States. Although USDA regulates a large portion of meat products, FDA sometimes regulates similar products, leading to confusion amongst agencies.

One issue agencies often find ambiguous is dietary supplement regulations for supplements containing meat ingredients. With USDA regulating most meat products and FDA regulating most supplements, which agency has jurisdiction over supplements with meat ingredients?

Get assistance with FDA compliance.

Registrar Corp’s Regulatory Specialists can help you determine which FDA regulations your product may be subject to, review your product’s label for compliance, and more.

For assistance, contact Registrar Corp by phone at +1-757-224-0177, or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

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Keep reading to learn more about how USDA and FDA are involved in regulating specific supplements.

Regulation Overlaps

The USDA’s Food Safety and Inspection Service (FSIS) regulates aspects of the safety and labeling of traditional (non-game) meats, poultry, and certain egg products. However, the Federal Meat Inspection Act (FMIA) and Poultry Products Inspection Act (PPIA), allow certain products to be exempt from USDA jurisdiction.

One way a meat product could be exempt from USDA regulation, possibly landing under FDA’s authority, is when the product contains meat or poultry ingredients in relatively small proportions.

Another cause for exemption is when the “historical perception” of a product is such that consumers don’t generally consider it to be a product of the meat or poultry industry.

These exemptions can complicate the division of responsibilities. For example, a manufacturer of prepared meat sandwiches may be subject to FDA’s regulations or USDA’s depending on whether the sandwiches are open faced or closed. Likewise, manufacturers of canned beans with little to no meat are subject to FDA’s regulations, but if the meat content exceeds 2%, those products are regulated by USDA.

Supplements With Meat Ingredients

For certain products containing meats, products with less than 3% raw meat, less than 2% cooked meat or other portions of the carcass, or less than 30% fat, tallow, or meat extract, alone or in combination, are under FDA jurisdiction. Those with more than 3% raw meat, 2% or more cooked meat or other portions of the carcass, or 30% or more fat, tallow, or meat extract, alone or in combination, are under USDA jurisdiction.

Some dietary supplements include meat products. Since FDA regulates dietary supplements as food, many believe the above guidelines apply to supplements as well.

However, supplements are not regulated according to these guidelines.

FDA regulates all supplements, regardless of meat content. Products exempt from USDA jurisdiction must still be prepared with USDA-inspected meat or poultry product or meat or poultry from an inspection system equivalent to the USDA inspection system. However, FDA oversees the manufacturing, ingredient safety, and labeling of all dietary supplements.

All dietary supplements are subject to FDA’s applicable regulations including, among others, registration, labeling and ingredient regulations, Master Manufacturing Records (MMRs), and adverse event reporting.

Get assistance with FDA compliance.

Registrar Corp’s Regulatory Specialists can help you determine which FDA regulations your product may be subject to, review your product’s label for compliance, and more.

For assistance, contact Registrar Corp by phone at +1-757-224-0177, or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

Get Assistance

Author


Fabiola Negron

Director of Food Safety

Widely respected in the Food Safety industry, Fabiola provides insightful education to food and beverage companies worldwide on U.S. FDA regulations resulting from the passage of the Food Safety Modernization Act (FSMA) in 2011. Her expertise in creating and reviewing Food Safety plans, helping U.S. importers comply with Foreign Supplier Verification Program (FSVP) regulations, and leading our Food Safety team have helped hundreds of companies comply with FDA food and beverage requirements.

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