On July 1, 2019, we blogged about the Supreme Court’s ruling striking down various Tennessee regulations whose purpose and effect was to limit the ability of non-Tennessee actors to compete in the retail market for alcoholic beverages. Tennessee Wine & Spirits Retailers Ass’n v. Thomas, 139 S.Ct. 2449 (2019). Last month, the Fifth Circuit addressed a somewhat different restriction imposed by the State of Texas. Wal-Mart Stores, Inc. v. Texas Alcoholic Beverage Com’n, 935 F.3d 362 (5th Cir. 2019).
The U.S. Food and Drug Administration (FDA) has launched an updated version of the Food Defense Plan Builder to help companies meet the requirements of the Mitigation Strategies to Protect Food Against Intentional Adulteration regulations at 21 C.F.R. part 121, also known as the Intentional Adulteration (IA) rule.
The U.S. Food and Drug Administration (FDA) recently announced it will hold a public meeting on October 21, 2019 to discuss the “New Era of Food Safety.” FDA is exploring new and emerging technology to assess risks and prioritize resources, while creating a digital, traceable, and safer system. The agency’s initial focus areas are traceability, smarter tools and approaches for prevention, the challenges of new business models and retail food safety, and support for the development of food safety cultures.
There have been numerous stories in the media about the heartbreaking illnesses associated with vaping. In this post on Husch Blackwell’s Cannabis Law Now blog, Seth Mailhot (with the help of Fall Clark Julia Banegas) explains the launch of a criminal probe by the FDA, the parallel investigation by the CDC and details how companies can appropriately prepare for an FDA inspection.
On July 10, 2019, we last blogged about the several states’ war on advertising plant- or cell-based products as “meat.” We suggested that the State of Missouri’s refusal to settle Tofurky’s lawsuit made no sense, because the State’s response to Tofurky’s motion for preliminary injunction effectively conceded the relief that Tofurky sought. Judge Gaitan evidently agrees. He has ordered the parties to participate in mandatory mediation.
The Federal Trade Commission (FTC) sent Warning Letters to three companies that sell products containing cannabidiol (CBD) and advertise that the products prevent, treat, or cure disease without substantiation of the purported health benefits. The products covered by these warnings letters were oils, tinctures, gummies, and dietary supplements.
Bacardi U.S., Inc. is facing a class action lawsuit in Florida due the use of grains of paradise in Bombay Sapphire® Gin. In Uri Marrache v. Bacardi USA, Inc., et al., Case No. 2019-023668-CA-01 (Miami-Dade Cir. Ct. Aug. 9, 2019), the plaintiff alleges that the use of grains of paradise violates a Florida state law preventing the adulteration of liquor with certain ingredients resulting in a violation of Florida’s Deceptive and Unfair Trade Practices Act (FDUTP).
The U.S. Food and Drug Administration (FDA) announced it will host a public meeting on September 27, 2019 to discuss FDA’s efforts to modernize standards of identity and provide information about changes the FDA could make to existing standards of identity.
This public meeting is part of FDA’s Nutrition Innovation Strategy, which seeks to improve nutrition and the healthfulness of foods and empower consumers to make better and more informed decisions about their diets and health. Specifically, FDA is considering modernizing food standards of identity in a way that will (1) protect consumers against economic adulteration, (2) maintain the basic nature, essential characteristics and nutritional integrity of food, and (3) promote industry innovation and provide flexibility to encourage manufacturers to produce healthier foods
FDA initially issued the standards of identity to protect consumers against economic adulteration, maintain the integrity of food, and reflect consumers’ expectations about food. However, because the standards were issued many years ago, FDA and stakeholders are concerned that that some standards are out of date and may impede innovation. In an effort to provide consumers more nutritious food options, FDA is particularly interested in changes that could be made across categories of standardized foods, known as horizontal changes, to provide flexibility for manufacturers to develop healthier foods.
The meeting will be held on September 27, 2019 from 8:30 am until 5:00 pm at the Hilton Washington DC/Rockville Hotel. Attendees are encouraged to register online to attend the meeting in person or via live webcast before September 20, 2019. The meeting will include introductory presentations, panel presentations, oral comments, and breakout sessions. Attendees interested in making oral comments in-person at the public meeting should sign up by September 12, 2019.
FDA is also accepting written comments on modernizing standards of identity until November 12, 2019.
Husch Blackwell has experience advising food manufacturers on FDA regulations, including those involving standards of identity. Our FDA lawyers have the required scientific and technical backgrounds to assist companies with understanding requirements for standards of identity and proposing changes that will be advantageous for their business. Contact Seth Mailhot, Emily Lyons, or your Husch Blackwell attorney for more details.
The U.S. Food and Drug Administration (FDA) recently released guidance to assist food and dietary supplement companies on how to convert the previous units of measure for folate, niacin, vitamin A, vitamin D, and vitamin E to the new units required on the updated Nutrition Facts and Supplement Facts labels. The guidance includes step by step instructions, conversion factors for each nutrient, and sample calculations for converting to the new units of measure.
Today, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would require health warnings on cigarette packages and advertising. The warnings include color images depicting some of the lesser-known health risks of cigarette smoking. This is FDA’s second attempt to require graphic warnings for cigarette packages and advertisements.