Drug and Cosmetic Act Archives - ALCOHOL LAW ADVISOR

FDA Announces Public Hearing on Products Containing Cannabis or Cannabis-Derived Compounds

by George Tzanetakos and McDermott Will & Emery | Apr 3, 2019 | Cannabis

On May 31, 2019, the Food and Drug Administration (FDA) will hold a public hearing on cannabis products. The hearing seeks to obtain scientific data on cannabis and cannabis-derived compounds, along with additional information regarding health and safety risks, manufacturing and product quality, marketing, labeling and the sale of such products.

The FDA’s notice announcing the hearing recognizes that the regulatory landscape surrounding cannabis continues to evolve at both the federal and state levels. At the state level, 33 states and Washington, DC, allow for the medical use of marijuana and 14 additional states have medical programs limited to cannabidiol (a/k/a CBD) products. Moreover, 10 states and Washington, DC have legalized marijuana for recreational use, while 13 additional states have decriminalized recreational marijuana possession in some form.

At the federal level, the Agriculture Improvement Act of 2018, Pub. L. 115-334 (often called the 2018 Farm Bill), removed hemp and its derivatives from the Controlled Substances Act, so they are no longer classified as controlled substances under federal law. This has prompted an avalanche of businesses marketing products containing hemp-derived compounds – most notably CBD – in ways that the FDA views as violations of the federal Food, Drug, and Cosmetic Act. According to the FDA, many questions remain concerning the safety implications of the widespread use of these products. Therefore, the FDA seeks relevant information to inform its position in regulating the development and marketing of cannabis products. (more…)

FDA to Hold Public Workshops Addressing Menu Labeling Final Rule

by Christopher M. Lahiff | Jun 14, 2016 | Food Safety and FDA

The US Food and Drug Administration (FDA) has announced a series of public workshops about menu labeling to help the industry comply with requirements to provide calorie and other nutrition information to consumers. The workshops will address the menu labeling final rule, which require certain chain restaurants and similar retail food establishments to give consumers nutrition information on standard menu items. The compliance date for these requirements is May 5, 2017.

These workshops are to continue FDA’s dialogue with the industry about implementation of the menu labeling final rule and provide additional clarity on the requirements. Interested parties will have the opportunity to discuss specific menu labeling questions and concerns directly with FDA subject matter experts through pre-scheduled one-on-one sessions. (more…)

Hard Cider for Brewers

by McDermott Will & Emery | Jul 15, 2014 | Advertising and Marketing, Distribution, Food Safety and FDA, TTB COLAs and Formulas

Hard cider has shown phenomenal growth in the past several years. With rising consumer demand, more and more craft brewers are entering this rapidly expanding market. Although hard cider is typically distributed and marketed like a beer product, the federal government and most states actually tax and regulate cider as a type of wine. Brewers contemplating the production of cider accordingly must carefully consider the legal issues surrounding cider production and distribution that distinguish cider from beer. This article outlines some of the most important (though certainly not all) of these issues.

This article was originally published in the May/June 2014 issue of The New Brewer.

Supreme Court Will Rule on Whether Agency-Approved Beverage Label Can Be Challenged as ‘False Advertising’ in Federal Court

by Robert W. Zelnick | Jan 15, 2014 | Advertising and Marketing, Food Safety and FDA, TTB COLAs and Formulas

On January 10, 2014, the U.S. Supreme Court agreed to hear an appeal by Pom Wonderful LLC against The Coca-Cola Company. The Court will examine whether Pom can bring a federal Lanham Act false advertising claim against a Minute Maid juice product label that had been approved by the U.S. Food and Drug Administration (FDA). (Pom Wonderful LLC v. The Coca-Cola Co., U.S. Supreme Court case no. 12-761).

At issue in the lawsuit is a Minute Maid label for “Pomegranate Blueberry Flavored Blend of 5 Juices.” The label presents the words “Pomegranate Blueberry” in larger type than the remainder of the phrase. Pom claimed that the label was misleading because the product contains 0.3 percent pomegranate juice and 0.2 percent blueberry juice.

A California federal trial court and the 9th Circuit federal appeals court in California both ruled that Pom could not bring a Lanham Act false advertising claim against the label, since it had been specifically examined and approved by the FDA. Pom has argued that the decisions were contrary to established law in other U.S. courts, and that federal regulations establish a floor –but not a ceiling — on what an advertiser is required to do to avoid a claim that the advertising is false and misleading. Coca-Cola has argued that product labeling that is specifically authorized by the Food, Drug and Cosmetic Act (FDCA) and approved by the FDA cannot be charged as false or misleading under another federal statute such as the Lanham Act.

Although the question before the Supreme Court is whether a private party can bring a Lanham Act claim challenging a product label regulated under the FDCA, the Supreme Court’s decision could potentially have significant implications for the alcohol beverage industry. For example:

If the Supreme Court rules that a competitor cannot bring a Lanham Act claim against a label that has been approved by the FDA, a natural question is whether the same rule will apply with regard to alcohol beverage labels that have been reviewed and approved by the Alcohol and Tobacco Tax and Trade Bureau (TTB) (by its terms, the Federal Alcohol Administration Act does not preempt the Lanham Act); and
If a Lanham Act claim would be barred against labels approved by TTB, a question may arise about whether a Lanham Act claim would be barred on elements of the label that TTB does not specifically review as a matter of policy – such as contrast, size and placement of label elements.

The Supreme Court is expected to hear argument this spring and decide the case by June 2014. Depending on the decision, alcohol beverage industry members could find they have additional insulation against a federal false advertising claim, but they may likewise be limited in bringing a federal false advertising lawsuit against a competitor’s label that has been approved by TTB.

FDA “Action Level” for Arsenic in Apple Juice

by McDermott Will & Emery | Jul 23, 2013 | Food Safety and FDA

On Friday, July 12, the U.S. Food and Drug Administration (FDA) proposed a new “action level” for arsenic in apple juice. The FDA’s Federal Register notice and other supporting documents that accompanied the announcement are linked below.

An action level generally establishes the threshold at which FDA will consider a food or food ingredient “adulterated” within the meaning of the Federal Food, Drug and Cosmetic Act (FD&C Act). For apple juice, FDA proposes a 10 parts per billion (PPB) level. This level is considerably lower than the 23 PPB “level of concern” previously established by FDA.

The FD&C Act’s ingredient safety standards apply to all “food” – a term defined broadly in the Act to encompass all alcohol beverages. Thus, the 10 PPB standard will be applied to apple juice used to manufacture hard cider. As such, cider producers should review the implications of the proposed standard on their own operations and give thought to implementing procedures to comply with the 10 PPB standard in the future.

Click here to read the FDA’s notice in the Federal Register.

Click here to read the draft Guidance for Industry Arsenic in Apple Juice: Action Level.

Click here to read the draft Supporting Document for Action Level for Arsenic in Apple Juice.