There is no denying over 40 years of evidence that alcohol is a potent neurodevelopmental teratogen and may be the most common cause of non-inherited intellectual disability (Merck Manual for Healthcare Professionals, online). With prevalence estimates of 2–5 % of school aged American children (May et al. 2014), ND-PAE is at least as concerning as HIV/AIDS or autism, each individually affecting less than 1 % of the U.S. population (CDC 2013a, b). The following statistical comparison provides insight into the magnitude of various neurodevelopmental conditions:

The Substance Abuse and Mental Health Services Administration (SAMHSA) FASD Center for Excellence reports prevention to be “cost effective.” An ND-PAE birth carries lifetime health costs of $860,000, which can be as high as $4.2 million (Lupton et al. 2004). The U.S. spends at least $5.4 billion per year on services for individuals with Fetal Alcohol Syndrome, or FAS (Harwood 2003). This includes neonatal care, management of developmental delays and birth defects, special education, a range of developmental disabilities services, mental and general health care costs, and supported living costs. These amounts do not include criminal justice services or substance abuse treatment for the 60–80 % of individuals with ND-PAE who end up incarcerated by age 18 and/or with substance use disorders (Streissguth and O’Malley 2000). Since FAS accounts for only 10–20 % of all ND-PAE cases, the extrapolated estimate for ND-PAE would be $21.6 billion.

The Pure Food and Drug Act in 1906 allowed regulation of foods, pharmaceuticals, and beverages. A 35 year old debate between the Food and Drug Administration (FDA) and the Bureau of Alcohol, Tobacco and Firearms (ATF) has focused on which agency governs the labeling of beverages containing alcohol. According to the United States Code of Federal Regulations, by definition, alcohol is both a food and a drug, underscoring the government’s duty to warn and responsibility to protect the public from harm. The Federal Food, Drug, and Cosmetic Act (FFDCA), §201. [301] defines “food” as:

The FFDCA does not make an exception for or separately define alcohol—an article used for drink for man. Alcohol has been used for centuries as a beverage made by fermenting (wine) grapes, other berries, and fruits; by brewing (beer) or distilling (liquor) hops, barley, and other grains. In a hearing before a Congressional Subcommittee on Alcoholism and Drug Abuse of the Committee on Human Resources of the 95th Congress (January 31, 1978), Commissioner Kennedy testified,

Since 1938 when the Federal Food, Drug, and Cosmetic Act was enacted, FDA has always considered alcoholic beverages to fall within the definition of ‘food’ and has taken enforcement actions against such products on charges of adulteration and, in at least one case, for misbranding.

The Food Packaging and Labeling Act (FPLA) of 1967 gave authority to the Federal Trade Commission and the FDA over labeling of “consumer commodities” for net contents, identity of commodity, and name and place of business of the product’s manufacturer, packer, or distributor. Additional regulations in the act “prevent consumer deception (or to facilitate value comparisons) with respect to descriptions of ingredients, slack fill of packages, lower price labeling, or characterization of package sizes” (FPLA 1967). Further, the Nutrition Labeling and Education Act (NLEA) of 1990 provides FDA with specific authority to require nutrition labeling of most foods regulated by the Agency; and to require that all nutrient content claims (i.e., ‘high fiber’, ‘low fat’, etc.) and health claims be consistent with agency regulations. Essentially, the “truth in labeling law” of 1990 now means that if orange juice is not fresh squeezed, the label cannot read “fresh squeezed.”

Drugs are defined in the same section of the FFDCA as: