Government warnings for addictive substances
Government warnings for addictive substances are health-related labels mandated by the U.S. government, primarily aimed at informing the public about the risks associated with the consumption of legal substances like alcohol and tobacco, as well as the misuse of prescription drugs. These warnings serve as crucial elements of public health campaigns, with specific emphasis on reducing dangerous behaviors such as overconsumption and substance misuse. Originating from legislative acts, such as the Alcoholic Beverage Labeling Act of 1988 and the Family Smoking Prevention and Tobacco Control Act of 2009, these warnings have evolved over time to reflect growing evidence about health risks, including birth defects from alcohol consumption during pregnancy and various health issues related to tobacco use.
The Office of the Surgeon General often issues these warnings, which must be prominently displayed on product packaging and advertisements. Enhanced labeling strategies, such as the inclusion of graphic images and direct statements about health risks, are designed to capture attention and encourage behavioral change among consumers. Despite widespread acknowledgment of these warnings, research indicates that their impact on long-term behavior change can be limited, highlighting the complexity of addressing substance misuse. Recent developments have also expanded warnings to cover opioid medications as a response to the rising opioid crisis, emphasizing the necessity of informed consumer choices regarding addictive substances.
Government warnings for addictive substances
ALSO KNOWN AS: Health warning labels; US surgeon general warnings; warning labels
DEFINITION: Health warning labels issued by the US government are evidence-based statements of risk associated with the general use of legal substances such as alcohol and tobacco and with the misuse of prescription drugs or other substances of abuse. Warnings are required on products themselves and on related advertisements as a part of public health campaigns. Government warnings are frequently issued through the Office of the Surgeon General as part of the US Department of Health and Human Services.
Purpose and Functions
The primary function of a government warning is to increase public knowledge about unsafe use of substances, particularly tobacco and alcohol products that can be purchased without a prescription by adults who have proper identification. These health warnings attempt to minimize dangerous substance activity by discouraging drug misuse and overuse. Warning label goals include the complete cessation of tobacco use and total abstinence from alcohol during any stage of pregnancy.
The first alcohol and tobacco warning labels developed as a result of acts by the US Congress. The Alcoholic Beverage Labeling Act of 1988 was passed in response to birth defects connected with alcohol use during pregnancy. Similarly, tobacco use has been tracked by the Office of the Surgeon General (OSG) since the 1920s. In the 1960s, tobacco use became a public health issue that resulted in government warnings because of early reports about the health damage to nonsmokers from exposure to secondhand smoke.
Government warning labels on alcohol and tobacco are intended to call separate attention to multiple risks. Label text may be decided by the OSG but enforcement is often implemented by affiliate agencies, such as the Alcohol and Tobacco Tax and Trade Bureau (TTB). One goal of the TTB is to protect public safety through oversight of federal laws about alcohol and tobacco product-labeling.
Label Formats
Product health warnings require text introductions of “Warning” or “Government Warning” in bold type on every package. To ensure visibility, all statements must be placed prominently on high-contrast sections of the package label, separate from other information.
Warning texts expand as evidence builds on the dangers of alcohol and tobacco use. Since 1989, the US government has mandated two warnings on alcoholic products. These warnings are “According to the Surgeon General, women should not drink alcoholic beverages during pregnancy because of the risk of birth defects” and “Consumption of alcoholic beverages impairs your ability to drive a car or operate machinery, and may cause health problems.”
In 2001, horizontal boxed text and conspicuous statements with surrounding white space were encouraged on beverage labels to increase attention to the warnings. In 2005, the OSG supplemented alcohol label warnings with an online news advisory to recommend total avoidance of any amount of alcohol during all stages of pregnancy, as evidenced by expanded research on fetal alcohol syndrome disorders.
Like alcohol warnings, tobacco warnings were initiated in Congress and adapted in time. Government warnings about tobacco changed little since the 1960s, until the statements were strengthened by the US Food and Drug Administration (FDA) in response to the Family Smoking Prevention and Tobacco Control Act of 2009. The new warnings, effective September 2012, comprise nine separate statements, a resource site (1-800-QUIT-NOW), and images of harmful tobacco effects on the body. Each warning contains one statement, one image, and the toll-free quit hotline.
The plain-language warnings, identified through literature review and public commentary, are as follows: cigarettes are addictive, tobacco smoke can harm your children, cigarettes cause fatal lung disease, cigarettes cause cancer, cigarettes cause strokes and heart disease, smoking during pregnancy can harm your baby, smoking can kill you, tobacco smoke causes fatal lung disease in nonsmokers, and quitting smoking now greatly reduces serious risks to your health. These changes, especially the new graphics, are negative reminders to heighten risk awareness, increase quit rates, and empower youth to avoid smoking.
On August 8, 2016, the FDA extended the regulatory authority of the federal Center for Tobacco Products (CTP) to cover all tobacco products, including electronic nicotine delivery systems (ENDS). ENDS are noncombustible tobacco products, including electronic cigarettes and vaporizers. As of 2018, the advertising and packaging for all covered tobacco products, including ENDS, must include the nicotine addictiveness warning. Products that are marketed for smoking cessation or other therapeutic purposes are excluded from the definition of tobacco products and are regulated as drugs.
In March 2020, the FDA finalized the Required Warnings for Cigarette Packages and Advertisements rule, establishing eleven new cigarette health warnings consisting of textual warning statements accompanied color images depicting the negative health consequences of smoking. These new warnings depict some of the lesser-known health risks of smoking.
In April 2023, the FDA announced new safety labeling changes for opioid pain medicines, including overdose risk, opioid-induced hyperalgesia (OIH), immediate release (IR) and extended-release/long-acting (ER/LA) implications, and the risks of abruptly stopping treatment. This label was a response to quickly-rising addiction cases in the United States over the course of the twentieth and twenty-first centuries.
Label Efficacy
Government warnings are updated infrequently, and public awareness of the standard labeling may introduce complacency. Government warnings on alcohol and tobacco are acknowledged by consumers, but effects on behavior are variable. For example, in the Alcoholic Beverage Label Evaluation survey from 1989 to 1995 (which surveyed persons in the Midwest), alcohol risks were noted by participants, but no significant changes in alcohol use resulted. Positive changes, such as lower rates of alcohol use while driving, appeared to level off after approximately three years. Thus, although awareness appears commonplace, the warnings do not appear to affect any long-term behavioral change.
Strategies for calling greater attention to the health risks include point-of-purchase notices, graphic images to supplement text labels, and even more prominent placement of warnings on the products. For example, cigarette products now require warning label placement on the top half of the front and back of each package or advertisement to pointedly display potential consequences of use. The use of graphics to transmit any health information is known to increase knowledge of risks, increase quit rates, and prevent new smokers.
Even greater distribution of warnings is available through state-regulated point-of-purchase programs, which require establishments that sell alcohol and tobacco to display warning signs at checkouts. For example, businesses that sell liquor must post the government warning about pregnancy and birth defect risks, and tobacco warning signs must be present where the tobacco products are sold.
To many critics of the FDA and to researchers of the opioid epidemic, the labeling of opioid substances was ineffective in that regulations were established far too late after cases of addiction had already risen far beyond any other addiction in the country. The clinical use of opioids quadrupled between 2000 and 2010, a rise that was accompanied by a nearly 300 percent increase in deaths involving these drugs, demonstrating their misuse. An estimated 2.5 million people eighteen years or older in the United States had opioid use disorder as of 2024. It can only be speculated, but some professionals believe that if patients had been more aware of the addictive nature of these substances, the overuse, misuse, and continued addiction of the drugs could have potentially been avoided.
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