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Proposed Class Action Lawsuit Alleges “Just a Tad Sweet” is an Unauthorized and Misleading Low Sugar Claim for Honest Tea Beverages

Buyers Claim Coke’s Tea Not Honest About Sugar Content (subscription to Law360 required) A proposed nationwide class of consumers who purchased the Honest brand of teas has sued the Coca-Cola company in New York federal court under various state laws for consumer protection, misrepresentation, breach of express and implied warranty, fraud, and unjust enrichment.  The … Continue Reading

FDA Publishes Statement on the Salinas-Linked Romaine Lettuce E. Coli 0157:H7 Outbreak and Status Update on Investigations

On December 12, 2019, the Food and Drug Administration (FDA), in conjunction with the Centers for Disease Control and Prevention (CDC) and state and local partners, reported an update of its investigation tracking three separate outbreaks linked to romaine lettuce caused by three different strains of E. coli O157:H7.  FDA reported that, through its traceback investigation … Continue Reading

European Food Safety Authority Warns that Eating Hemp Foods Can Cause Elevated THC Levels if Ingested in High Quantities

On January 7, 2020, a European Food Safety Authority (EFSA) report looked at tetrahydrocannabinol (THC) levels in 12 different categories of hemp foods, including hemp oil, breads and teas.  EFSA also reviewed THC levels in foods, like cereals, pasta, chocolate, and beer.  More than 1,500 samples were collected from countries, such as Romania, Czech Republic, … Continue Reading

New Official Controls Regulation in the European Union

On December 14, 2019, the new Official Controls Regulation (OCR) 2017/625 entered into force in the European Union (EU). While the new OCR does not revolutionize the system in place, it provides certain key changes to ensure that food and feed are safe in Europe. Until December 13, 2019, the EU system of official controls … Continue Reading

FSIS Publishes Updated Guidelines for “Non-GMO” Labeling Claims

On December 30, 2019, USDA’s Food Safety and Inspection Service (FSIS) published updated labeling guidelines on “Statements That Bioengineered or Genetically Modified Ingredients or Animal Feed Were Not Used in the Production of Meat, Poultry, or Egg Products.” The guidelines, which were originally announced in August 2016, outline the agency’s approach of approving labels containing “not-bioengineered,” “not genetically … Continue Reading

Bipartisan Group of Representatives Introduces Bill that Would Give FDA Authority to Regulate CBD as a Dietary Supplement (Law360 subscription required)

On January 13, 2020, the House Agriculture Committee Chairman Collin Peterson (D- Minn.) introduced H.R. 5587, which would include hemp derived CBD in the definition of dietary supplements under the Federal, Drug and Cosmetic Act.  The bill would also require a study and report from the U.S. Department of Agriculture, which oversees the production of … Continue Reading

FDA Responds to Three Dietary Fiber Citizen Petitions

On January 10, the FDA announced that it intends to propose that “glucomannan” be added to the definition of dietary fiber at 21 CFR 101.9(c)(6)(i). Based on available evidence, FDA determined that the scientific evidence suggests that glucomannan can help reduce blood cholesterol.  Glucomannan is commonly found in the tuber or root of the elephant … Continue Reading

FDA’s New Enforcement Priority Guidance for E-Cigarettes Focuses on Flavored Cartridge-Based Devices and Companies and Products that FDA Views as Targeting Kids

On January 8, 2020 FDA published its new final compliance policy guidance, Guidance for Industry: Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization (January 2020), which goes into effect in February. Under the final guidance, beginning February 6, 2020, FDA intends to prioritize enforcement of … Continue Reading

Release by FDA, USDA, and EPA of New Joint Website on Biotechnology Regulation

  The U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA) launched a Unified Website for Biotechnology Regulation on January 9, 2020.  According to the FDA News Release, this new website is part of President Donald J. Trump’s Executive Order on Modernizing the Regulatory Framework for Agricultural … Continue Reading

California Finalizes the Listing of Cannabis (Marijuana) Smoke and Δ-9-Tetrahydrocannabinol as Reproductive Toxicants Under Proposition 65

As our readers may recall, the California Office of Environmental Health Hazard Assessment (OEHHA) tasked the Developmental and Reproductive Toxicant Identification Committee (DARTIC) of OEHHA’s Science Advisory Board with evaluating whether cannabis (marijuana), marijuana (cannabis) smoke, cannabis extracts, and Δ-9-Tetrahydrocannabinol (Δ9-THC) have been shown to cause reproductive toxicity for purposes of listing under California’s Proposition 65 … Continue Reading

Mexican Chamber of Deputies Approves Bill that Prohibits Use of Dairy Terms on Plant-Based Alternatives

In late December 2019, Mexico’s Chamber of Deputies’ voted in favor of a reform to the Ley de la Propiedad Industrial (“Industrial and Federal Property of Consumer Protection law”), which would make regulations on misleading advertising more stringent.  This prohibition will have an impact on plant-based alternatives that currently use dairy terms, such as “soymilk” … Continue Reading

CSPI Asks FDA Not To Make Sweeping Changes to Food Standards of Identity

As our readers may recall, FDA held a public meeting on September 27, 2019, to discuss FDA’s efforts to modernize food Standards of Identity (SOI) and to provide information about changes the FDA could make to existing SOIs. Section 401 of the Federal Food, Drug, & Cosmetic Act gives FDA authority, whenever in its judgment … Continue Reading

FDA Issues Final Guidance Document on Nutrition Facts Label and Serving Size Rules

In May 2016, FDA issued final rules changing the Nutrition Facts label for packaged foods and updating regulations on serving sizes to – among other things – provide realistic Reference Amounts Customarily Consumed (RACCs).  Detailed summaries of both rules may be found here.  For manufacturers with $10 million or more in annual food sales, the compliance … Continue Reading

Bipartisan Senate Bill Would Formalize FDA-USDA Jurisdiction over Cell-Based Meat

Senators Mike Enzi (R-WY) and Jon Tester (D-MT) have introduced a bill, the “Food Safety Modernization for Innovative Technologies Act,” that would formalize the agreement between FDA and USDA to jointly regulate cell-based meat products. Consistent with the March 2019 agreement between the two agencies, the bill would give FDA authority to evaluate the technology … Continue Reading

UK Journal of Epidemiology & Community Health Claims Food Labels Showing How Much Exercise is Needed to Burn off Food May Help Combat Obesity

The Royal Society for Public Health UK (Royal Society), an independent, multi-disciplinary charity dedicated to the improvement of the public’s health and wellbeing, claims that most consumers do not understand the meaning of calorie intake in the context of energy expenditure.  Royal Society states that “physical activity calorie equivalent or expenditure” labeling (“PACE labeling”), which … Continue Reading

Senate Confirms Dr. Stephen Hahn as New FDA Commissioner

On December 12, the U.S. Senate confirmed Dr. Stephen Hahn to be the next FDA Commissioner. Dr. Hahn will take over for Admiral Brett Giroir, Assistant Secretary for Health within the Department of Health and Human Services, who has been overseeing the FDA since Ned Sharpless’s tenure as “acting” FDA Commissioner expired in November 2019. … Continue Reading

USDA Solicits Comments on Instructions for Validation of Refining Processes for Bioengineered Food Disclosure Standard

The United States Department of Agriculture (USDA) Agricultural Marketing Service (AMS) announced today that it is soliciting comments on its draft instructions for validation of refining processes under the National Bioengineered Food Disclosure Standard rule (“the rule”). As previously covered on this blog, the rule was published on December 21, 2018, and requires entities to … Continue Reading

FDA Enforcement Actions Following Findings in Food Facility Inspections of “Serious Violations” of CGMP Requirements in 21 CFR Part 117

We previously reported on FDA’s March 16, 2018 warning letter to Bhavani Fruits and Vegetables LLC for “serious violations” of Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Part 117.  This is believed to have been the first time FDA formally cited Part 117 CGMP regulations promulgated under FSMA in a warning letter (as … Continue Reading

Putative Class Action Alleges Company’s CBD Products for Humans and Animals Violate Federal Law (subscription to Law360 required)

As our readers may recall, on November 25, FDA issued warning letters to 15 companies for illegally selling a variety of FDA-regulated products (for humans and animals) containing cannabidiol (CBD), in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA emphasized that CBD lacks an appropriate regulatory status for use in these … Continue Reading

U.S. Court of Appeals for the Seventh Circuit Finds that Plaintiffs Did Not Suffer a Concrete Harm When They Purchased Allegedly Underfilled Boxes of Chocolate (subscription to Law360 required)

On December 9, 2019, the Seventh Circuit found that an Illinois federal district court properly tossed a proposed slack-fill class action against Fannie May, a Chicago-based chocolate maker.    In 2018, Plaintiffs claimed that they relied on the size of the packaging to gauge the amount of product inside and would have paid less for the … Continue Reading

FDA Provides States Flexibility to Start Routine Inspections on Small Farms As Early As January 1

As previously reported, both states’ departments of agriculture and FDA have begun visits to produce farms to conduct inspections for compliance with the Produce Safety Rule. The FSMA final Produce Safety Rule was published on November 27, 2015 (80 FR 74353) and establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of … Continue Reading

NY Judge Denies Class Certification in ‘No Artificial Flavors’ Lawsuit

Chef Denied Class Cert. In Pringles Artificial Flavoring Row (subscription to Law360 required) In the past five years or so consumers have shown increased concern about perceived health issues with so-called “artificial” ingredients.  Whether or not ingredients are “artificial” is, therefore, a hotly debated issue at the center of many false advertising lawsuits. On December … Continue Reading

USDA Finalizes Rule For SNAP Requirements for Able-Bodied Adults Without Dependents

In the last two years, the Supplemental Nutrition Assistance Program (SNAP; colloquially known as the “Food Stamps” Program) has been a major point of contention within political circles.  For example, the additional SNAP requirements proposed in the 2018 Farm Bill threatened to derail its passage and the United States Department of Agriculture’s (USDA’s) proposal to … Continue Reading

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