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.

Continue Reading Meatless Meat Update

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.

Continue Reading FTC Issues Warning Letters to Three CBD Companies

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).

Continue Reading Class Action Tests Allowed Ingredients in Gin under Florida Law

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.

Contact Us

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.

Continue Reading FDA Releases Guidance on Convert Units of Measure for Certain Nutrients on Nutrition and Supplement Facts Labels

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.

Continue Reading FDA Proposes New Health Warning for Cigarette Packages and Advertisements

On July 30, 2019, the U.S. Food and Drug Administration (FDA) issued its first Warning Letter to an importer for violations of the Foreign Supplier Verification Program (FSVP) requirements at  21 C.F.R. Part 1, Subpart L (21 C.F.R. §§ 1.500 through 1.514).  The Warning Letter was issued to a U.S. importer related to imported tahini implicated in a multi-state Salmonella Concord outbreak in spring 2019.

Continue Reading FDA Issues First Warning Letter under FSVP Regulations

On May 9, 2019, we blogged about the challenge to the Minnesota farm winery statute. The statute allows Minnesota farms to bypass the traditional three-tier method of distributing alcoholic beverages and sell directly to retailers and consumers. To qualify as a farm winery, however, more than 50% of the grapes it uses must be grown in Minnesota. Two farm wineries argued that the statute violated the dormant commerce clause by discriminating against out-of-state grape growers.

Continue Reading Minnesota Wine Update

Avoiding Trademark Disputes in the Alcoholic Beverage Industry

In the first installment of our series on trademark disputes in the alcoholic beverage industry, we identified the risks facing industry participants on the branding front, regardless if they are “entrepreneurs” entering the market for the first time or established companies launching a new brand.  As we advised, the risks are significant and have the potential to completely derail your new brand.

Continue Reading Steer Clear with Your Beer Branding