Beyoncé's Fda Laws: Creating A Superstar?

The FDA enforces laws and regulations to protect public health and safety. Its authority covers a wide range of products, from food and drugs to cosmetics and tobacco. Notably, the FDA does not require premarket approval for cosmetic products, except for colour additives, and places the responsibility for product safety on manufacturers and marketers. This raises an interesting question: could FDA laws ever create a celebrity like Beyoncé?

FDA's authority over cosmetics

The Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labelling Act (FPLA) are the two most important laws concerning the marketing of cosmetics in the United States. The Food and Drug Administration (FDA) regulates cosmetics under the authority of these laws.

The FDA's authority over cosmetics differs from its authority over other products it regulates, such as drugs, biologics, and medical devices. Cosmetic products and ingredients do not need FDA premarket approval, except for colour additives. However, the FDA can take enforcement action against products on the market that are not in compliance with the law, or against firms or individuals who violate the law. Manufacturers may use any ingredient in the formulation of a cosmetic, provided that the ingredient and the finished cosmetic are safe under labelled or customary conditions of use.

The FDA may conduct examinations and investigations of products, inspect establishments where products are manufactured or held, and seize adulterated or misbranded cosmetics. Adulterated or misbranded foreign products may be refused entry into the United States. The FDA may also request a federal district court to issue a restraining order against the manufacturer or distributor of the violating cosmetic to prevent further shipment. Additionally, the FDA may initiate criminal action against a person violating the law.

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of the FDA's authority to regulate cosmetics since the FD&C Act was passed in 1938. MoCRA provides the FDA with new authorities, including records access and mandatory recall authority. It also establishes new requirements for adverse event reporting, facility registration and product listing, and safety substantiation. Furthermore, MoCRA requires the FDA to establish regulations for Good Manufacturing Practices for facilities that manufacture or process cosmetic products, fragrance allergen labelling, and standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products.

FDA's enforcement of the Federal Food, Drug and Cosmetic Act

The Federal Food, Drug, and Cosmetic Act (FD&C Act) is a set of laws passed by the United States Congress in 1938, which gives authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. The FD&C Act is the main federal law regulating the safety of most foods, food additives, colour additives, dietary supplements, prescription and non-prescription drugs, medical devices, cosmetics, and tobacco products.

The Act's primary purpose is to "safeguard" and "protect" consumers from exposure to dangerous products that affect public health and safety. It does this by regulating covered articles from their introduction into interstate commerce to their delivery to the ultimate consumer. The Act also regulates a host of disparate products but generally prohibits two basic acts: "adulteration" and "misbranding". FD&C Act Section 301 makes it illegal to distribute directly or indirectly a covered product in interstate commerce that is adulterated or misbranded. The Act defines the terms "adulteration" and "misbranding" with respect to specific products.

The FDA does not approve cosmetic products, but the Act prohibits the marketing of adulterated or misbranded cosmetics. The FDA can inspect cosmetics manufacturing facilities to ensure that cosmetics are not adulterated. The FDA can ask the company to recall their product or sue them if a company is selling an adulterated or misbranded product.

Section 510(k) of the FD&C Act requires device manufacturers who must register to notify the FDA at least 90 days in advance of their intent to market a medical device. This allows the FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Section 408 of the FD&C Act authorises the EPA to set tolerances or maximum residue limits for pesticide residues on foods.

FDA's regulation of tobacco products

The FDA's regulation of tobacco products is a critical aspect of public health policy. The Family Smoking Prevention and Tobacco Control Act, enacted in 2009, grants the FDA the authority to regulate the manufacture, distribution, and marketing of tobacco products. This includes cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products deemed appropriate by the Secretary of the FDA. The FDA's regulatory approach to tobacco is grounded in science and considers the health of the population as a whole, including both users and non-users.

The FDA's evaluation of new tobacco products differs from its "safe and effective" standard for medical products. Instead, the FDA considers the risks and benefits of tobacco products to the population as a whole. This approach is mandated by law and is reflected in the development of regulations, which must also consider the effects on the population regarding the initiation and cessation of tobacco use. The FDA's regulations are based on the Tobacco Control Act and the Federal Food, Drug, and Cosmetic Act, which is the basic food and drug law in the US.

One of the key focuses of the FDA's tobacco regulation is nicotine content. The FDA has proposed limiting nicotine levels in cigarettes and other combusted tobacco products to make them minimally addictive or non-addictive. The proposed rule sets a maximum nicotine content level of 0.70 milligrams of nicotine per gram of total tobacco, a significant reduction compared to the average nicotine content in top cigarette brands. The FDA targets nicotine content because it is a fixed characteristic, while nicotine yield can vary based on users' behaviours, such as inhaling more deeply.

The FDA's proposed rule on nicotine content covers a range of combusted tobacco products, including cigarettes, cigarette tobacco, roll-your-own tobacco, cigars, and pipe tobacco. Notably, it excludes electronic nicotine delivery systems, smokeless tobacco, and other non-combusted tobacco/nicotine products. The FDA justifies this focus by stating that combusted tobacco products are responsible for the majority of deaths and diseases due to tobacco use. The proposed rule would require premarket authorization for modified tobacco products, and companies would have a limited time to obtain authorization to market their modified products.

In addition to nicotine content, the FDA also provides guidance and issues standards related to tobacco product regulation. This includes assistance to small tobacco product manufacturers in complying with the requirements. The FDA's mission is to enforce laws and regulations that protect consumers' health, safety, and financial interests. While the FDA's tobacco regulations are a significant step forward, they do not affect the Secretary's authority to regulate non-tobacco products or expand their regulatory scope beyond tobacco-related matters.

FDA's legal authority over medical devices

In the United States, the FDA regulates the sale of medical device products. Before a medical device can be legally sold in the U.S., the person or company that wants to sell the device must seek approval from the FDA. To gain approval, they must present evidence that the device is reasonably safe and effective for a particular use. The FDA monitors the ongoing safety and efficacy of regulated marketed devices through MedWatch, the FDA Safety Information and Adverse Event Reporting Program. MedWatch allows manufacturers, health care professionals, and consumers to report serious problems related to the use of drugs and medical devices.

The FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating firms that manufacture, repackage, relabel, and/or import medical devices. The FDA issued the Quality Management System Regulation (QMSR) Final Rule, which amends the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820). This incorporates the international standard specific for medical device quality management systems set by the International Organization for Standardization (ISO), ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes. The final rule is the latest action taken by the FDA to promote consistency in the regulation of devices. This action is intended to harmonize the FDA’s CGMP regulatory framework with that of other regulatory authorities. The rule is effective February 2, 2026, two years after its publication. Until then, manufacturers are required to comply with the QS regulation.

The FDA has also been granted the authority to collect user fees for select medical device premarket submissions to help improve efficiency, quality, and predictability of medical device submission reviews. The Medical Device User Fee and Modernization Act of 2002 authorizes the FDA to charge a fee for medical device premarket notification 510(k) reviews. A 510(k) must demonstrate that the device is substantially equivalent to one legally in commercial distribution in the United States before May 28, 1976, or to a device that has been determined by the FDA to be substantially equivalent. A small business may pay a reduced fee. The application fee applies to Traditional, Abbreviated, and Special 510(k)s. The payment of a premarket review fee is not related to the FDA's final decision on a submission.

The FDA has also been provided with express authority to approve or clear devices with a predetermined change control plan (PCCP). It can also ban devices for one or more intended uses, and banned devices are not legally marketed devices. The FDA can require manufacturers to perform post-market surveillance on permanently implanted devices if permanent harm or death could result from device failure. It can also order device recalls and impose civil penalties for violations of the FD&C Act.

FDA's power to take action against companies

The U.S. Food and Drug Administration (FDA) has broad powers to take action against companies that violate its laws and regulations. The FDA's primary role is to protect and promote public health by regulating products in the food, drug, and medical device categories.

One of the FDA's key powers is its ability to conduct inspections and collect samples of regulated products offered for entry into the U.S. market. The FDA can issue a Notice of FDA Action, allowing it to examine products and collect samples for testing. If a product is found to be in violation, it can be refused entry, and the importer is given an opportunity to present evidence to address the violation.

The FDA also has the power to take enforcement actions, including seizure of products, civil money penalties, bond actions, and prosecution. These actions can be taken against companies found to be in violation of FDA laws and regulations, particularly those making false or unproven claims about their products' abilities to treat or cure diseases. For example, the FDA has taken action against companies illegally selling products claiming to treat Alzheimer's disease or opioid addiction.

In addition, the FDA has the authority to regulate tobacco products. In 2015, the FDA took its first regulatory action against a tobacco product, ordering a company to stop selling cigarette-like products called bidis. While the FDA cannot ban tobacco products, it can require ingredient listings and regulate warning notices on packaging.

The FDA also prioritizes cybersecurity modernization to protect the data supporting its regulatory decision-making. The FDA experienced a significant increase in cyber incidents during the pandemic and is working to enhance its cybersecurity defenses to address evolving threats.

Overall, the FDA has extensive powers to take action against companies that violate its regulations, with a focus on protecting public health and ensuring the safety and efficacy of regulated products.

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