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…and Drug Administration to adopt a price disclosure requirement under the Federal Food, Drug, and Cosmetic Act (FDCA). When it became clear the FDCA does not authorize price disclosure mandates,…
On March 24, 2021, Virginia became the latest state to enact a prescription drug price transparency law. Similar to other state drug price transparency laws (see, for example, our coverage…
…and the manufacturer does not agree to provide it, the manufacturer must report to the Department information on costs of manufacturing, distribution, research and development, marketing and advertising, prices and…
…Moreover, California recently enacted the California Food Safety Act, prohibiting the manufacturing, selling, delivering, distributing, or holding food that contains BVO, with a $5,000 civil penalty for first violations, as…
…adulterated under section 402(a)(1), in that the food was contaminated with Salmonella, and also adulterated under section 402(a)(4), in that the food was manufactured under insanitary conditions whereby it may…
…In addition, section 204 authorized FDA to issue a regulation imposing additional recordkeeping requirements on facilities that manufacture, process, pack, or hold foods that FDA designates as “high risk” (such…
…would have needed credible evidence that a food presented a threat of serious adverse health consequences or death to humans or animals. Now, FDA only needs a reason to believe…
…on fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, and protein. Under proposed 21 C.F.R. § 101.8, certain vending machines would be required to disclose the…
…be materially different in a property such as composition, nutritional composition, functional characteristics, and organoleptic properties, will different labeling be warranted. If material differences exist, the next question will be…
Welcome to the latest edition of HPM’s monthly wrap up of food, beverage and supplement news, including regulations, guidances, events, and whatever else is catching our eye. It’s been quite…
…National List of Allowed and Prohibited Substances (National List). In recent years, on several occasions, consumers have brought actions against companies for marketing organic foods, notably infant formula, alleging that…
…also recommends that Congress enact “comprehensive, uniform, and risk-based food safety legislation.” It is not difficult to find areas of the current food safety oversight system that are sorely in…
…effort to revise the regulations. The survey will focus on five issues: employee training, sanitation and personal hygiene, allergen controls, process controls, and recordkeeping. Selection of these issues was based…
…and Rosa DeLauro, Chair of the House Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Entities of the Committee on Appropriations. The Food, Drug, and Cosmetic Act…
…29, 2010, FDA will announce that it is requesting data and information from “all interested parties,” including the food industry, graphic and package designers, marketing experts, and the nutrition community, both…