Department of Health and Human Services

On January 8, 2021, the US Department of Health and Human Services (HHS) announced that it would be finalizing a regulation

Background on the RuleThe Department of Health and Human Services (HHS) is proposing a regulation that would build sunset

The High Cost of Current FDA Drug Review PoliciesOn average, it takes 466 days for a new drug to be approved for marketing by

The proposed “Focused Mitigation Strategies to Protect Food against Intentional Adulteration” rule is intended to supplement four previous bioterrorism rules to reduce the probability of a successful terrorist act involving processed food.1 Congress mandates an essentially redundant regulation while paying no attention to the identified threat of intentional contamination through the mechanism of foot and mouth disease, which could cost the US economy in excess of $10 billion.

This public interest comment estimates the range of annual benefits (costs avoided) associated with e-cigarette use as $15.6 billion to $49.2 billion and that 2.4 million to 6.4 million smokers may potentially become ex-smokers by using e-cigarettes. Estimates are based on a range of quit rates from the current literature and assume all smokers interested in quitting use e-cigarettes. Even a fraction of estimated benefits (costs saved) are substantial. These estimates indicate the FDA is jeopardizing public health by not estimating benefits associated with e-cigarettes using data from readily available studies on their efficacy as harm-reduction tools.

Pursuant to the Nutrition Labeling and Education Act (NLEA) of 19901 and the Dietary Supplement Health and Education Act (DSHEA) of 1994,2 the Food and Drug Administration (FDA) issued regulations requiring food and dietary supplement products to display labels declaring their nutrient content. The regulations specified the format for nutrition labeling as well as the reference values to use in declaring the nutrient content.

The Nutrition Labeling and Education Act of 1990 (NLEA) gives the FDA authority to regulate information displayed on food products and describes how a lack of certain types of information would be considered misbranding.1 Two rules, sharing one preliminary regulatory impact analysis (PRIA),2 have been proposed based on the authority granted by NLEA.3 The first rule covered by the PRIA, titled “Food Labeling: Revision of the Nutrition and Supplement Fact Labels” (NPRM1), includes a laundry list of potential changes that are designed to “assist consumers in maintaining healthy dietary practices.”4 The changes required are numerous and involve changes to labels, increases in recordkeeping, and new analytic requirements.

The Food Safety Modernization Act, signed in 2011, directs the Food and Drug Administration (FDA) to adopt regulations requiring facilities that manufacture, process, pack, or hold food, including animal food, to implement preventive controls to ensure that the food is not “adulterated,” as defined in section 402 of the Food, Drug, and Cosmetic Act.