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Year in Review: 2019 Food, Beverage and Supplement Litigation Roundup

2019 was another active year for new regulatory activity and litigation targeting the food, beverage, and supplement industries.

In this roundup, Bryan Cave Leighton Paisner LLP presents a collection of regulatory developments, key court decisions, and notable settlements that were reached in 2019 and early 2020.

The highlights of this 2019 roundup include:

  • New federal legislation governing food labeling.
  • New regulations and a burst of litigation regarding CBD-based products.
  • An update on slack fill litigation.
  • Notable rulings, trials, and settlements.
  • Prop 65 and food safety update.
  • A preview of areas to watch in 2020.

FDA Releases Final Rule Allowing Voluntary Risk Reviews of Food Additives to Continue

The Food and Drug Administration (FDA) says its final rule allowing outside groups to evaluate food additive risks will streamline its “Generally Recognized as Safe” (GRAS) reviews.

The agency recently released its GRAS final rule for its food additive program, switching reviews from a more formal but slower “petition-based” process to a voluntary “notification” process.

Under the federal Food, Drug and Cosmetic Act (FD&C Act), any substance that is intentionally added to food is a food additive that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excepted from the definition of a food additive.

The use of a food substance may be GRAS either through scientific procedures or, for a substance used in food

Prop 65 Developments – Notices of Violation for BPA in Receipts and Containers and OEHHA’s Listing of Styrene and Pesticides

Bryan Cave attorney Merrit Jones recently published two client alerts regarding California’s Prop 65 that impact the food and agriculture industries.

The first alert relates to the bisphenol-A (BPA) listing that took effect on May 11, 2016.  Already, two notices of violation have been served alleging harmful exposure to the chemical without providing a warning. One notice alleges BPA in receipt paper, and another alleges BPA in plastic water cooler jugs.  BPA is believed to be present in a wide variety of plastic consumer products, including many reusable food and drink containers, as well as in the epoxy lining in most canned food and beverage containers.  OEHHA has adopted an emergency regulation authorizing temporary point-of-sale warnings for exposure to BPA from canned and bottled food and beverages. That regulation is expected to remain in effect for more than a year in order to allow manufacturers time to implement alternatives

The FDA Dishes Out Food Label Changes

The current food label will soon be no more. After two decades, the Food and Drug Administration (FDA) just finalized the new Nutrition Facts label for packaged foods. Making it easier for consumers to make better informed food choices, the FDA announced that the changes are based a combination of public input, updated scientific information, new nutrition and public health research, and more recent dietary recommendations from expert groups.

For more information on the label changes from the Bryan Cave Food and Beverage Industry Team, see this client alert.

The European Commission Takes Back the Reins on Novel Food

With the continuing influx of foreign foods, algae, insects, microorganisms and foods with new molecular structures in our diets, the European Union has decided to put in place a harmonized procedure to vet – or not – these “novel foods” before they are placed on the market. This procedure is set out in the recent EU-wide Regulation which will enter into force beginning 2018. “Novel food” is defined as any food product which was not generally consumed in the European Union before 1997 (the date of the first European legislation on this subject) or innovative food developed using new technologies.

Bryan Cave lawyers Kathie Claret and Raphael Roditi prepared this article on the new regulation, which will be of interest to food manufacturers and importers in the EU.

New FDA Guidance on “Gluten Free” Claims

Following up on last year’s “gluten-free” labeling rule, the FDA has now published guidance to help industry interpret and apply the rule.  All food products claiming to be “gluten-free” must comply with the rule by August 5, 2014.  At its essence, according to the FDA, “gluten-free” means that the food does not contain an ingredient made from a gluten-containing grain unless that grain has been processed to remove the gluten and the remaining gluten in he ingredient does not exceed 20 parts per million.  Food containing unavoidable amounts of gluten, such as from cross-contact, must still be below the 20 ppm threshold to use the “gluten-free” claim.  The rule does not require testing of gluten levels, but a company using the claim is responsible for ensuring that its product meets the established threshold to avoid product being adulterated and/or misbranded.

Interestingly, FDA has specifically stated that the “gluten-free” claim can

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