© Springer International Publishing Switzerland 2016Monty Nelson and Marguerite Trussler (eds.)Fetal Alcohol Spectrum Disorders in Adults: Ethical and Legal PerspectivesInternational Library of Ethics, Law, and the New Medicine6310.1007/978-3-319-20866-4_3
Neurodevelopmental Disorder Associated with Prenatal Alcohol Exposure: Consumer Protection and the Industry’s Duty to Warn
Potomac, Maryland, USA
Los Angeles, California, USA
In this chapter, we posit that manufacturers and distributors of alcohol (i.e., the alcohol industry) should participate in and be responsible for the health and human costs of Neurodevelopmental Disorder associated with Prenatal Alcohol Exposure (ND-PAE). Alcohol is a food and drug by federal definition in the United States and should be under FDA regulation, like pharmaceuticals and tobacco. More precise labeling and advertising, to include the 2005 revised U.S. Surgeon General’s advisory (Centers for disease control and prevention (CDC). 2005. Notice to readers: Surgeon general’s advisory on alcohol use in pregnancy. Morbidity and Mortality Weekly 54(09):229), will promote universal prevention through preconception approaches. Regulation and taxation of alcohol would finance targeted screening, intervention and treatment services.
Nomenclature Disclaimer: With the publication of the Diagnostic and Statistical Manual 5th Edition (American Psychiatric Association, 2013), the category of “Other Specified Neurodevelopmental Disorder” includes “Neurodevelopmental Disorder associated with Prenatal Alcohol Exposure (ND-PAE),” with proposed diagnostic criteria listed in Section 3 under “Conditions for Further Study.” Because the topic presented in this paper has little to do with nomenclature and more to do with ethical responsibility versus legal obligation, we are opting to refer to all individuals affected by maternal alcohol use as ND-PAE and defer readers to the diagnostic criteria in DSM-5. To avoid confusion, we will use ND-PAE throughout this chapter in lieu of FASD or other prior nomenclature, with the exception of Fetal Alcohol Syndrome (FAS), where necessary.
Premium Wordpress Themes by UFO Themes
Why Prevent Neurodevelopmental Disorder Associated with Prenatal Alcohol Exposure?
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:
Neurodevelopmental Disorder associated with Prenatal Alcohol Exposure (ND-PAE): “CDC studies have shown that 0.2–1.5 cases of Fetal Alcohol Syndrome (FAS) occur for every 1,000 live births in certain areas of the United States. Other studies using different methods have estimated the rate of FAS at 0.5–2.0 cases per 1,000 live births. Scientists believe that there are at least three times as many cases of FASDs as FAS.” (www.cdc.gov/ncbddd/fasd/data.html) Worldwide research puts ND-PAE as high as 2–5 % of school aged children (May et al. 2009, 2014).
Autism: “About 1 in 88 children [just over 1 %] (11.3 per 1000 in 2008) has been identified with an autism spectrum disorder (ASD), according to estimates from CDC’s Autism and Developmental Disabilities Monitoring (ADDM) Network.” (www.cdc.gov/ncbddd/autism/data.html)
Cerebral Palsy (CP): “prevalence varied by site, ranging from 2.9 per 1,000 8-year-olds in Wisconsin to 3.8 per 1,000 8-year-olds in Georgia. The average prevalence of CP across the four sites was approximately 3.3 per 1,000 or 1 in 303 8-year-old children in the United States.” (www.cdc.gov/ncbddd/cp/data.html)
Down’s Syndrome: each year about 6,000 babies (about 1 of every 691 babies) in the United States are born with Down syndrome. (www.cdc.gov/ncbddd/birthdefects/downsyndrome.html)
Spina Bifida: “…each year, about 1,500 babies are born with spina bifida.” (www.cdc.gov/ncbddd/spinabifida/data.html)
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.
Legislation to Regulate and Accurately Label Alcohol
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.  defines “food” as:
articles used for food or drink for man or other animals,
chewing gum, and
articles used for components of any such article.
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:
articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and
WordPress theme by UFO themes