The Daily Intake

Legal and Regulatory updates for the food and supplement industry

As previously reported on this blog, in November 2018 FDA, in conjunction with the CDC, state officials, and Canadian food and public health officials, investigated an outbreak of E. coli O157:H7 infections in multiple US states and Canadian provinces. The investigation determined the cause of the outbreak was the consumption of contaminated romaine lettuce. Indeed, thirty (83%) of 36 ill consumers interviewed reported eating romaine lettuce the week before illness onset. All E. coli…
FDA has issued warning letters and online advisories to a number of dietary supplement companies whose products claim to prevent, treat, or cure Alzheimer’s disease and other serious conditions.  The disease claims cause the supplements to be considered unapproved new drugs that violate the Federal Food, Drug, and Cosmetic Act. The products in question include tablets, capsules, and oils containing ingredients such as avocado oil, green tea extract, omega-3 fatty acids, black cumin seed oil,…
A New York federal court ordered a consumer class action against KIND LLC to move forward after a two-year stay. Consumers are suing KIND for allegedly mislabeling its snack products as both “non-GMO” and “all natural,” even though the products purportedly contain synthetic and genetically modified ingredients.  On September 15, 2016, U.S. District Judge William H. Pauley III stayed the “all natural” claims pending possible new FDA guidelines on use of the term.  At the…
On February 11, FDA Commissioner Scott Gottlieb, M.D. announced a new plan for modernizing and strengthening dietary supplement regulation and oversight. In making the announcement, Dr. Gottlieb pointed out that supplement use is increasing with three out of every four American consumers taking a dietary supplement on a regular basis. Also, since Congress passed the Dietary Supplement Health and Education Act (DSHEA) 25 years ago, the dietary supplement market has grown significantly—from a $4…
  As covered on this blog, FDA has worked to strengthen the recall process for food, drugs, medical devices, and cosmetics in response to a report by the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services concluded that FDA’s recall process can be too slow and puts consumers at risk.  21 CFR Part 7, Subpart C provides guidance on policy, procedures, and industry responsibilities for recalls (including product…
On February 7 FDA initiated enforcement action against a Miami, Florida Walgreens and a Charleston, South Carolina Circle K store for repeated sales of tobacco products to minors.  The enforcement action, called a no-tobacco-sale-order (NTSO) would prevent the individual stores from selling any tobacco product for thirty days. In its press release, FDA noted that Walgreens is the top violator amongst pharmacies that sell tobacco products, having been cited for tobacco sales to minors…
Novel Food Regulation (EU) 2015/2283 describes the authorization process for novel food products in the European Union (EU). “Novel food” is defined as food that had not been consumed to a significant degree by humans in the EU before May 15, 1997. “Novel Food” can be newly developed, innovative food, food produced using new technologies and production processes, as well as food which is or has been traditionally eaten outside of the EU. We previously…
City and state officials in New York, Ohio, and Maine have placed embargoes on food products containing cannabidiol (CBD).  The embargoes, which appear to have all begun in January, require restaurants and retailers to remove all CBD-containing food products from their shelves and prohibit their sale.  In all three jurisdictions, however, restaurants and retailers were allowed to keep the embargoed items. New York City’s Department of Health and Mental Hygiene (DOH) said in a statement
Recently introduced Kids’ Meal Bills in Connecticut and Rhode Island would prohibit restaurants from including soft drink beverages on children’s menus and in children’s meals. More specifically, Connecticut House Bill 7006 would limit beverages listed on children’s menus to “water, sparkling water, flavored water with no added sweeteners, unflavored milk or a nondairy milk alternative,” effective January 1, 2020. It was referred to the Joint Committee on Children on January 31, 2019, and is one…
  As previously covered on this blog, the City of San Francisco passed legislation in June 2015 that required health warnings to be placed on advertising for sugar-sweetened beverages (i.e., nonalcoholic beverages with caloric sweeteners that contain more than 25 calories per 12 oz.). Specifically, the warning would have read: “WARNING: Drinking beverages with added sugar(s) contributes to obesity, diabetes, and tooth decay. This is a message from the City and County of San…