Mandatory disclaimers are government-mandated messages that describe what a product is not or does not do that sellers must include in their advertising.
In the United States, mandatory messages first appeared after the passage of the Federal Caustic Poisons Act (FCPA) of 1927, a law that ordered sellers of poisons to provide warning labels on their bottles. Prior to the passage of the FCPA, some sellers would use unusually shaped or colored bottles to signify the presence of a dangerous substance. After the Act, manufacturers mostly used plain bottles and displayed warning labels on them.
The agency responsible for enforcing the regulations of the FCPA was the Food and Drug Administration (FDA). Today, the FDA is the main body responsible for mandating disclaimers in the United States. Mandatory disclaimers are still used widely in the U.S.
The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products. As of 2017, 3/4th of the FDA budget is paid by people who consume pharmaceutical products, due to the Prescription Drug User Fee Act.
The imposition of mandatory disclaimers is an exception to the First Amendment that was allowed by the Supreme Court of the United States in Valentine v. Christensen (1942). The exception to the First Amendment applies to commercial speech, which the Court defined as speech that “proposes a commercial transaction.”
The First Amendment to the United States Constitution prevents the government from making laws which respect an establishment of religion, prohibit the free exercise of religion, or abridge the freedom of speech, the freedom of the press, the right to peaceably assemble, or the right to petition the government for redress of grievances. It was adopted on December 15, 1791, as one of the ten amendments that constitute the Bill of Rights.
Later cases have attempted to limit the extent of the “commercial speech" restriction on free speech, such as Virginia State Board of Pharmacy v. Virginia Citizens Consumer Council (1976) and Florida Bar v. Went For It (1995).
Voluntary disclaimers, however, have been used since the beginning of advertising. They lead to more persuasive advertising, and they provide useful information to consumers. Experimental studies suggest that mandatory disclaimers do not help buyers and may lead them to make inferior decisions.
Caveat emptor is Latin for "Let the buyer beware". Generally, caveat emptor is the contract law principle that controls the sale of real property after the date of closing, but may also apply to sales of other goods. The phrase caveat emptor and its use as a disclaimer of warranties arise from the fact that buyers typically have less information than the seller about the good or service they are purchasing. This quality of the situation is known as 'information asymmetry'. Defects in the good or service may be hidden from the buyer, and only known to the seller.
Bait-and-switch is a form of fraud used in retail sales but also employed in other contexts. First, customers are "baited" by merchants' advertising products or services at a low price, but when customers visit the store, they discover that the advertised goods are not available, or the customers are pressured by sales people to consider similar, but higher priced items ("switching").
False advertising is the use of false, misleading, or unproven information to advertise products to consumers. The advertising frequently does not disclose its source. One form of false advertising is to claim that a product has a health benefit or contains vitamins or minerals that it in fact does not. Many governments use regulations to control false advertising. A false advertisement can further be classified as deceptive if the advertiser deliberately misleads the consumer, as opposed to making an honest mistake.
The United States Federal Food, Drug, and Cosmetic Act, is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations.
The nutrition facts label is a label required on most packaged food in many countries. Most countries also release overall nutrition guides for general educational purposes. In some cases, the guides are based on different dietary targets for various nutrients than the labels on specific foods.
Virginia State Pharmacy Board v. Virginia Citizens Consumer Council, 425 U.S. 748 (1976), was a case in which the United States Supreme Court held that a state could not limit pharmacists’ right to provide information about prescription drug prices. This was an important case in determining the application of the First Amendment to commercial speech.
In law, commercial speech is speech or writing on behalf of a business with the intent of earning revenue or a profit. It is economic in nature and usually attempts to persuade consumers to purchase the business's product or service. The Supreme Court of the United States defines commercial speech as speech that "proposes a commercial transaction".
Central Hudson Gas & Electric Corp. v. Public Service Commission, 447 U.S. 557 (1980), was an important case decided by the United States Supreme Court that laid out a four-part test for determining when restrictions on commercial speech violated the First Amendment of the United States Constitution. Justice Powell wrote the opinion of the court. Central Hudson Gas & Electric Corp. had challenged a Public Service Commission regulation that prohibited promotional advertising by electric utilities. Justice Brennan, Justice Blackmun, and Justice Stevens wrote separate concurring opinions, and the latter two were both joined by Justice Brennan. Justice Rehnquist dissented.
Fine print, small print, or "mouseprint" is less noticeable print smaller than the more obvious larger print it accompanies that advertises or otherwise describes or partially describes a commercial product or service. The larger print that is used in conjunction with fine print by the merchant often has the effect of deceiving the consumer into believing the offer is more advantageous than it really is. This may satisfy a legal technicality which requires full disclosure of all terms or conditions, but does not specify the manner of disclosure. There is strong evidence that suggests the fine print is not read by the majority of consumers.
Bates v. State Bar of Arizona, 433 U.S. 350 (1977), was a United States Supreme Court case in which the Court upheld the right of lawyers to advertise their services. In holding that lawyer advertising was commercial speech entitled to protection under the First Amendment, the Court upset the tradition against advertising by lawyers, rejecting it as an antiquated rule of etiquette.
Valentine v. Chrestensen, 316 U.S. 52 (1942), was a case in which the Supreme Court of the United States ruled that commercial speech in public thoroughfares is not constitutionally protected.
44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484 (1996), was a United States Supreme Court case in which the Court held that a complete ban on the advertising of alcohol prices was unconstitutional under the First Amendment, and that the Twenty-first Amendment, empowering the states to regulate alcohol, did not operate to lessen other constitutional restraints of state power.
The Nutritional Health Alliance is an industry lobby group which lobbies United States law makers to pass industry friendly health legislation.
The regulation of food and dietary supplements by the U.S. Food and Drug Administration is a process governed by various statutes enacted by the United States Congress and interpreted by the U.S. Food and Drug Administration ("FDA"). Pursuant to the Federal Food, Drug, and Cosmetic Act and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the labeling about both the composition and the health benefits of foods.
The Family Smoking Prevention and Tobacco Control Act, is a federal statute in the United States that was signed into law by President Barack Obama on June 22, 2009. The Act gives the Food and Drug Administration the power to regulate the tobacco industry. A signature element of the law imposes new warnings and labels on tobacco packaging and their advertisements, with the goal of discouraging minors and young adults from smoking. The Act also bans flavored cigarettes, places limits on the advertising of tobacco products to minors and requires tobacco companies to seek FDA approval for new tobacco products.
Regulation of tobacco by the U.S. Food and Drug Administration began in 2009 with the passage of the Family Smoking Prevention and Tobacco Control Act by the United States Congress. With this statute, the Food and Drug Administration (FDA) was given the ability to regulate tobacco products.
This article is about the history of the United States Food and Drug Administration.
Consumer Health Laws are laws that ensure that health products are safe and effective and that health professionals are competent; that government agencies enforce the laws and keep the public informed; professional, voluntary, and business organizations that serve as consumer advocates, monitor government agencies that issue safety regulations, and provide trustworthy information about health products and services; education of the consumer to permit freedom of choice based on an understanding of scientific data rather than misleading information; action by individuals to register complaints when they have been deceived, misled, overcharged, or victimized by frauds.
Zauderer v. Office of Disciplinary Counsel of Supreme Court of Ohio, 471 U.S. 626 (1985), was a United States Supreme Court case in which the Court held that states can require an advertiser to disclose certain information without violating the advertiser's First Amendment free speech protections as long as the disclosure requirements are reasonably related to the State's interest in preventing deception of consumers. The decision effected identified that some commercial speech may have weaker First Amendment free speech protections than non-commercial speech and that states can compel such commercial speech to protect their interests; future cases have relied on the "Zauderer standard" to determine the constitutionality of state laws that compel commercial speech as long as the information to be disclosed is "purely factual and uncontroversial".