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The following are settlements reached with US authorities against pharmaceutical companies to resolve allegations of "off-label" promotion of drugs. Under the Federal Food, Drug, and Cosmetic Act, it is illegal for pharmaceutical companies to promote their products for uses not approved by the Food and Drug Administration (FDA), and corporations that market drugs for off-label indications may ...
In the United States, "Under the law, cosmetic products and ingredients do not need FDA premarket approval." [56] The EU and other regulatory agencies around the world have more stringent regulations. [57] The FDA does not have to approve or review cosmetics, or what goes in them, before they are sold to consumers.
However, the FDA does not have the authority to order recalls of cosmetics. [22] [23] If a company is selling a product that is adulterated or misbranded, the FDA can ask the company to recall their product or sue them. [21] The FDA can and does inspect cosmetics manufacturing facilities to ensure that cosmetics are not adulterated. [21]
Most states prohibit an individual’s name, image, or likeness from being used for commercial purposes without approval under so-called "right of publicity" laws, according to legal experts.
Magic Power Coffee drinkers should stop using the product immediately, warns the U.S. Food and Drug Administration. In a statement, the FDA said Magic Power Coffee, an instant coffee marketed as a ...
In most countries, a marketing authorisation is valid for a period of 5 years. After this period, one should apply for renewal of the marketing authorisation, usually by providing minimal data proving that quality, efficacy and safety characteristics are maintained and the risk-benefit ratio of the medicinal product is still favourable.
The FDA's proposed rule would require manufacturers test samples of talc-containing cosmetic products for asbestos with methods including polarized light and transmission electron microscopy ...
Like other food substances, dietary supplements are not subject to the safety and efficacy testing requirements imposed on drugs, and unlike drugs they do not require prior approval by the FDA; [40] however, they are subject to the FDA regulations regarding adulteration and misbranding. The FDA can take action against dietary supplements only ...