Department of Health and Human Services

The Department of Health and Human Services (HHS) is a vast agency with many subparts. Two agencies within HHS that have particular authority over food include the FDA and the Centers for Disease Control and Prevention (CDC). The U.S. Surgeon General is also part of HHS and the position is described below.

The Food and Drug Administration

Congress granted the FDA its modern powers under the Food Drug and Cosmetic Act of 1938 (FDCA). The FDA received increased authority to address food safety and prevent foodborne illness through the Food Safety Modernization Act 2011 (FSMA). The FSMA provides the FDA with the authority to protect the public from being exposed to food that “will cause serious adverse health consequences or death.”^[1] Thus, the Act provides the FDA with the authority to inspect food facilities, obtain industry food safety plans, and issue mandatory recall orders if the food company fails to voluntarily recall unsafe food upon the FDA’s request.^[2] The FDA also has the authority to issue civil monetary fines in the context of food safety.^[3] These issues are discussed further in Chapter 5.

The FDA is also responsible for the labeling of all food not under the jurisdiction of the USDA, which comprises the vast majority of food available for sale in the country. Congress passed the Nutrition Labeling and Education Act of 1990 (NLEA), which gave the FDA the authority to require factual nutrition information and ingredient lists on food packaging. The NLEA also provided the agency with the authority to regulate health- and nutrition-related claims on food packaging. It prohibits misbranded food, which is defined as food having a false or misleading label, food that is not properly identified, food that is missing required disclosures or nutrition information, or food labeled with health and nutrition claims that are not made according to specific requirements.^[4] The FDA’s final regulations pursuant to the NLEA were enacted in 1993. In 2014, the FDA proposed revisions to the NLEA to update disclosure requirements, primarily the Nutrition Facts Panel. These developments are discussed in Chapter 6.

It is important to note that the FDA has less authority to address labeling violations than food safety issues. Although the FDA was granted extensive authority under the FSMA, the FDA’s primary method of addressing food labeling violations is to issue warning letters to food companies that violate the FDCA.^[5] The FDA sends a letter warning the company that it violated the FDCA and notes an expectation that the company will resolve and correct the violation. For example, Coca-Cola created a carbonated beverage called Diet Coke Plus, which was a soft drink with added vitamins. This product violated the FDA regulations prohibiting the fortification (or addition of nutrients) to soft drinks and candy.^[6] The FDA sent a warning letter to Coca-Cola explaining its violations of the FDCA, recommending the company take prompt action to resolve the violations, and seeking a responsive letter.^[7]

Like other administrative agencies, the FDA enacts regulations through Notice and Comment Rulemaking under the Administrative Procedures Act.^[8]

The FDA also issues less formal guidance documents. These do not have the full force of law and are not required to go through Notice and Comment Rulemaking, although the agency sometimes does accept comments on them. Guidance documents provide information to the food companies on the “FDA’s current thinking on a topic.”^[9] Companies are prompted but not required to follow the advice in guidance documents and the FDA is not required to enforce any violation of the suggestions in a guidance document. In the food context, the FDA has issued guidance on a wide array of issues, such as records maintenance, reducing toxins in food, prevention of foodborne illnesses, and distinguishing between food and dietary supplements.^[10]

• [1] 21 USCS § 342.
• [2] Food and Drug Administration. Background on the FDA Food Safety Modernization Act(FSMA). http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm239907.htm
• [3] 21 USCS § 333.
• [4] 21 USCS § 343.
• [5] J. L. Pomeranz. A Comprehensive Strategy to Overhaul FDA Authority for Misleading FoodLabels. American Journal of Law & Medicine. 2013139: 617-647.
• [6] 21 CFR § 104.20(a).
• [7] Coca-ColaCompany(The) December 10, 2008. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048050.htm
• [8] 5 USCS § 553.
• [9] Food and Drug Administration. Guidances. http://www.fda.gov/regulatoryinformation/guidances/
• [10] Food and Drug Administration. Food Guidance Documents. http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/default.htm