On January 14, 2014, FDA issued final guidance to help companies determine whether a product qualifies as a “dietary supplement” or “conventional food” as defined by the federal Food, Drug & Cosmetic Act (FD&C). While dietary supplements and conventional foods are both considered “foods” under the FD&C, there are important differences in the regulatory requirements

On January 14, the Food and Drug Administration (“FDA”) published a guidance document entitled Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements, with the goal of reminding industry: (1) about the Federal Food, Drug and Cosmetic Act’s requirements governing substances added to conventional foods, including beverages; and (2) that those same

President Obama signed into law the Food Safety Modernization Act (FSMA) nearly three years ago. After significant delays, the FDA has made significant progress this year towards implementing this act and published five key proposed FSMA implementing regulations. These proposed regulations and related FDA enforcement policies will have far-reaching implications for how food for both

The Food and Drug Administration (FDA) has published its long awaited final rule defining “gluten-free” labeling requirements. Under the final rule, companies may choose to promote foods using “gluten free” labeling claims provided that the labeled foods qualify under the definition prescribed by FDA in the final rule. Under FDA’s final rule, “gluten-free” is defined

The Department of Health & Human Services (HHS) Office of Inspector General (OIG) has released two reports examining regulation of the dietary supplement industry, Dietary Supplements: Companies May Be Difficult to Locate in an Emergency, and Dietary Supplements: Structure/Function Claims Fail to Meet Federal Requirements. Dietary supplement manufacturers should carefully review the reports because the reports include recommendations that, if adopted, would significantly change the way FDA regulates dietary supplements. OIG recommends that FDA:

  • Seek statutory authority to impose civil penalties for non-compliance with facility registration requirements,
  • Seek statutory authority to require pre-market approval for structure/function claims,
  • Revise the way FDA maintains records of notification letters for new marketing claims,
  • Expand market surveillance of dietary supplements, and
  • Educate the industry about facility registration requirements

Continue Reading

FDA released a draft guidance today identifying additional food categories to be included as part of the mandatory registration program for any domestic or foreign facility that manufactures, processes, packs or holds food for human or animal consumption. The draft guidance acts on authority delegated by section 102 of the Food Safety Modernization Act (FSMA), which amends section 415 of the Federal Food, Drug & Cosmetic Act (FD&C Act) to allow FDA to require food facilities to register based on “other food categories” as determined appropriate by FDA, “including by guidance.”
Continue Reading

The Food and Drug Administration (“FDA”) has submitted its Report to Congress on the FDA Foreign Offices. Under the Food Safety Modernization Act (FSMA), FDA is required to update Congress on the agency’s progress in establishing foreign posts and working with foreign government counterparts to further FDA’s mission. Companies that import food, drugs, devices or cosmetics into the United States or are part of the import supply chain for food, drugs devices or cosmetics may wish to review the report to learn how FDA currently plans to rely on foreign posts to accomplish its mission, and what the foreign posts have accomplished so far.

FDA currently has thirteen foreign posts: three in China, two in India, four in Latin America, three in Europe, one in South Africa to serve the Sub-Saharan Africa region, and one in Jordan to serve the Middle East and North Africa. FDA has requested permission to establish an additional post in Brazil but has no current plans for additional posts. Decisions to establish foreign posts are based on the volume of imported products, the magnitude of problems associate with imported products, the value derived from leveraging activities and resources of foreign counterpart regulatory authorities, the ability of FDA to contribute to promoting U.S. public health priorities, the stability of political and security environments in the foreign country, and the political relationships and receptiveness of the foreign country to the presence of FDA staff. FDA staff are deployed to U.S. embassies or consulates. In Europe, FDA also has senior technical experts embedded in the European Medicines Agency and in the European Food Safety Authority.
Continue Reading

The Food and Drug Administration (“FDA”) has released a question and answer guide to its implementation of the fee provisions of the Food Safety Modernization Act of 2011. The purpose of the fee provisions is to allow the FDA to recover reinspection, recall noncompliance, and importer program related costs from domestic and foreign facilities and

On August 18, 2011 the FTC issued a request for public comment and advance notice of proposed rulemaking (ANPR) as part of the Commission’s review of the costs, benefits, necessity, and regulatory and economic implications of its “Retail Food Store Advertising and Marketing Practices” rule, commonly called the “Unavailability Rule,” 16 C.F.R. Part 424.


On Friday, the Food and Drug Administration (FDA) released a draft guidance for industry that could have far-reaching consequences for companies that market dietary supplements. The draft guidance, Dietary Supplements: New Dietary Ingredient Notifications and Related Issues, is intended to give dietary supplement manufacturers and distributors “information and recommendations to help them decide when