Trade Group Petitions FDA to Allow CBD Supplements

  • In the wake of rapidly increasing sales, FDA has continued to maintain that dietary supplements containing hemp-derived cannabidiol (CBD) are illegal under the Federal Food, Drug & Cosmetic Act. FDA officials have previously stated that the agency is exploring additional regulatory pathways available to hemp products containing CBD, but predicted that completing a potential rulemaking proceeding could span 3 to 5 years even under the best of circumstances.
  • Amidst Congressional pressure for FDA to act quickly in establishing a regulatory framework for CBD and outside efforts urging Congress to pass legislation that would make CBD derived from hemp a legal dietary ingredient, the Consumer Healthcare Products Associated (CHPA) submitted a citizen petition to FDA requesting that the agency issue regulations to establish a clear pathway for the use of CBD in dietary supplement manufacturers. CHPA expressed a preference for an interim final rule as opposed to full notice and comment rulemaking but asked that if notice and comment rulemaking was used that FDA issue guidance or an enforcement discretion position at the same time.
  • Under CHPA’s proposal, FDA should require manufacturers of CBD-containing dietary supplements to submit a new dietary ingredient notification (NDIN) for CBD and comply with other applicable laws, including using appropriate labeling and claims, adhering to GMPs, and reporting serious adverse events. The petition notes that requiring NDINs would provide FDA with much-needed data on CBD that could help inform FDA’s broader regulatory framework for CBD products. CHPA’s petition is consistent with the approach that we believe FDA is considering as it evaluates whether CBD can be authorized for use in dietary supplements.

New Proposed Class Action Over “Organic Dehydrated Cane Juice Solids”

 Whole Foods Accused of Hiding Sugar In Oatmeal Ingredients (subscription to Law360 required)

  • As previously covered on this blog, a claim against Whole Foods involving the term “evaporated cane juice” (ECJ) was dismissed from the “Food Court” (i.e., the Northern District of California) in 2015 because inconsistencies in the plaintiff’s statements and actions make it implausible that he was misled to believe that “juice” means “healthy” or that ECJ is a healthy unrefined sugar.  We also reported that cases against other defendants alleging the use of ECJ is misleading on various product labels were put on hold while the Food and Drug Administration (FDA) worked to finalize relevant guidance.
  • As covered here, FDA released final guidance on May 25, 2016, reaffirming the Agency’s view that sweeteners derived from sugar cane should not be declared on food labels as “evaporated cane juice” and that the term is “false or misleading because it suggests that the sweetener is ‘juice’ or is made from ‘juice’ and does not reveal that its basic nature and characterizing properties are those of a sugar.”  Now a proposed class of consumers have alleged in a federal lawsuit, filed in New York on November 15, 2019, that they were misled by the term “organic dehydrated cane juice solids” in the ingredients statements on Whole Foods’ instant oatmeal labels.  According to the plaintiffs, the oatmeal labels use a term that is comparable to evaporated cane juice and similarly suggest that the ingredient at issue came from a fruit or vegetable, such as berries that are featured prominently on the front of the package.
  • The plaintiffs in this new lawsuit are seeking unspecified damages and an injunction against the use of the allegedly misleading ingredient statement.  The request for an injunction could be moot, however, as it appears that all of the sweetened instant oatmeal products on Whole Foods’ website currently list “cane sugar” or “organic cane sugar,” rather than any variation of “cane juice,” in the ingredient statements.

 

 

Amid Ongoing Trade Talks, U.S. and China Remove Import Restrictions on Poultry Products

  • On November 14, the United States Department of Agriculture (USDA) announced that China plans to lift its ban on poultry imports from the United States. China originally instituted its ban on U.S. poultry in 2015, amid concerns over highly-pathogenic avian influenza (HPAI) outbreaks. While these concerns have subsided over the past four years, China had yet to lift its ban on U.S. poultry until now. As part of USDA’s announcement, United States Trade Representative Robert Lighthizer and U.S. Secretary of Agriculture Sonny Perdue released a statement hailing the decision as a win for U.S. farmers and expressing optimism about the new export opportunities.
  • This news comes one week after the USDA Food Safety and Inspection Service (FSIS) issued a final rule removing its own ban on Chinese imports of certain poultry products. While processed poultry products could already be imported from China, it was conditioned on the requirement that the products be derived from poultry slaughtered in the United States or in other countries with a poultry slaughter inspection system equivalent to that of the United States. Following an extensive evaluation of China’s laws, regulations, control programs, and inspection procedures, FSIS determined that these systems were equivalent to those of the United States. Notably, the new rule only covers fully cooked poultry products, and does not remove the current restrictions on Chinese raw poultry imports instituted by the USDA Animal and Plant Health Inspection Service (APHIS), due to concerns over animal disease risk.
  • The respective removals of U.S. and China poultry import restrictions are part of ongoing trade negotiations between the two countries. For several years, there have been growing congressional efforts to ease these restrictions, specifically with regard to poultry imports. As previously covered on this blog, in July 2017, a bipartisan group of 37 U.S. senators led by Senator Thad Cochran (R-Miss.) and Senator Mark Warner (D-Va.) called on Secretary of Agriculture Sonny Perdue to press for the swift reopening of the Chinese market to U.S. chicken and turkey exports. Today’s announcement marks an important milestone in the materialization of that effort.

Ben & Jerry’s Sued Over “Happy Cows” Claim (subscription to Law360 required)

  • On October 29, 2019, Plaintiff James Ehlers, a former Vermont gubernatorial candidate, filed a proposed class action complaint in the federal U.S. District Court in Vermont.  In the complaint, the Plaintiff alleges that Ben & Jerry’s and its parent company, Unilever, (collectively “Defendants”) falsely advertised that the milk and cream in Ben & Jerry’s ice cream products come exclusively from “happy cows.”  The lawsuit accuses the Defendants of breach of express warranty, unjust enrichment, and violating the Vermont Consumer Protection Act, which declares unlawful all “[u]nfair methods of competition in commerce and unfair or deceptive acts or practices in commerce.”
  • In the complaint, the Plaintiff argues that Defendants “breached consumer trust” by representing that the milk and cream in their products were sourced from cows on dairies that participate in Ben & Jerry’s “Caring Dairy Program.”  Ben & Jerry’s “Caring Dairy Program” offers farmers a program for “evaluating, implementing and continuously improving sustainable agricultural practices on their farms.”  Although the Plaintiff acknowledges that Ben & Jerry’s products are made from milk that comes from farms participating in the “Caring Dairy Program,” he alleges that products are also made with milk from cows on “factory-style, mass-production dairy operations.”  Ehlers alleges that Defendants acted “unfairly and deceptively…by omitting information about the percentage of milk and cream in Ben & Jerry’s Products that originates from regular factory-style, mass-production dairy operations.”
  • The plaintiff seeks damages for ice cream purchasers nationwide, and to stop Ben & Jerry’s from claiming its milk and cream came from “happy cows.”  We will continue to monitor this case as well as other interesting class action lawsuits that target the food industry.

Plant-Based Plaintiffs Drop Mississippi Lawsuit After Favorable Resolution, but US House Reps Introduce Real MEAT Act

  • On November 7, the Plant Based Foods Association (PBFA) and Upton’s Naturals dropped their federal lawsuit challenging Mississippi’s legislation that banned plant-based foods sold in Mississippi from using meat-related terms on labels, after Mississippi proposed new regulations. As our readers may recall, in early September, the Mississippi Department of Agriculture and Commerce proposed new regulations to implement the law that would allow the use of meat-related terms on the labels of plant-based food if one or more of the following terms, or a comparable qualifier, is prominently displayed on the front of the package: “meat free,” “meatless,” “plant-based,” “veggie-based,” “made from plants,” “vegetarian,” or “vegan.” PBFA and Upton’s dropped the lawsuit on the same day the revised labeling regulations took effect.
  • PBFA and Upton’s lead attorney, Justin Pearson of the Institute for Justice, called the outcome a “total victory” and stated that the PBFA and Upton’s “simply wanted to continue using clear labels with the terms consumers understand best. In response to our lawsuit, the Mississippi Department of Agriculture has done the right thing, so there is no need to move forward with the lawsuit.”
  • While the Mississippi lawsuit has been dropped, countless other state suits continue on. And at the federal level, plant-based products face a new potential labeling barrier. U.S. House of Representatives Anthony Brindisi (D-NY) and Roger Marshall (R-KS) introduced the Real Marketing Edible Artificials Truthfully (MEAT) Act of 2019 (H.R. 4881). The Real MEAT Act would amend the Federal Food, Drug, and Cosmetic Act to “ensure that consumers can make informed decisions in choosing between meat products such as beef and imitation meat products.” The Act states that “any imitation meat food product, beef, or beef product, shall be deemed to be misbranded unless its label bears, in type of uniform size and prominence, the word ‘imitation’ immediately before or after the name of the food and a statement that clearly indicates the product is not derived from or does not contain meat.” The bill alleges that imitation products create confusion in the marketplace. The Real MEAT Act was introduced on October 28, 2019 and has been referred to the House Committee on Energy and Commerce and the Committee on Agriculture. We will continue to report on any developments of the Real MEAT Act and other developments that impact the labeling of plant-based foods and meat products.

Ocean Spray Agrees to Settle ‘No Artificial Flavors’ Suit (subscription to Law360 required)

  • A consumer class action lawsuit, first filed in California state court on September 19, 2017 alleged that Ocean Spray Cranberries Inc.’s “CranGrape” and “CranApple” beverages were false and misleading under California and federal law. Specifically, the complaint alleged that the “CranApple” drink includes DL-malic acid derived from petrochemicals to achieve its apple flavor while the CranGrape drink includes a fumaric acid ingredient synthesized from petrochemical feedstocks to achieve its grape flavor. Despite those artificial ingredients, the complaint alleged that those beverage labels claimed that they contained “No Artificial Flavors.”
  • The issue at the center of the lawsuit was whether those compounds function and qualify as artificial flavors in the juice products. In prior court hearings, Ocean Spray argued that the malic and fumaric acid in their juice products were used to control pH and acidity levels and were not present to flavor the products. The plaintiff argued that malic acid can be used as a flavor or flavor enhancer, and the low level of synthetic malic acid and fumaric acid in the drink would function as a flavor.
  • Pending approval by U.S. District Judge Gonzalo Curiel, a proposed settlement filed on November 8, 2019 would require Ocean Spray to pay $5.4 million into a settlement fund. In addition, Ocean Spray agreed to cease manufacturing its “CranGrape” and “CranApple” products with labels that contain the claim “no artificial flavors” within 12 months after the final approval effective date.

FDA Will Extend Enforcement Policy Allowing Some “Co-Manufacturers” Additional Time to Implement Certain FSMA Supply-Chain Program Requirements

 

  • We reported on the Food and Drug Administration’s (FDA) November 2017 guidance giving certain co-manufacturers two more years to comply with requirements for a supply-chain program for certain raw materials and other ingredients under the FDA Food Safety Modernization Act (FSMA) – Preventive Controls for Human Foods, Preventive Controls for Animal Food, and the Foreign Supplier Verification Programs.  FDA determined that more time was needed for brand owners to establish new contracts with the firms the brand owners select to supply their co-manufacturers.  To comply with the supply-chain program requirements, co-manufacturers often need detailed information about suppliers that only the brand owner has, and that cannot be shared because of confidentiality clauses in the contracts between brand owners and the co-manufacturers’ suppliers.
  • On November 6, 2019, the date that FDA’s enforcement policy applicable to certain co-manufacturers would have expired, FDA announced that a forthcoming notice will be published soon in the Federal Register extending the enforcement discretion policy while FDA works to better understand additional challenges industry is facing in trying to meet the FSMA supply-chain requirements.  The non-enforcement policy extension was granted after requests from the American Frozen Food Institute (AFFI) and Food and Beverage Issues Alliance (FBIA) indicated their members have yet to overcome the many contractual and logistical barriers to compliance with the supplier verification requirements as they relate to brand owners and co-manufacturers and further consultation between FDA and industry is needed to resolve these compliance challenges.
  • FDA’s November 6, 2019 announcement does not identify a new compliance deadline for co-manufacturers benefitting from the new extension of FDA’s enforcement policy for the relevant FSMA supply-chain program requirements.  Co-manufacturers are still responsible for other applicable requirements under the Federal Food, Drug, and Cosmetic Act.

 

FTC Publishes New Guidance for Social Media Influencers: “Disclosures 101”

  • While the Food and Drug Administration (FDA) is the primary regulatory authority for food, dietary supplements, cosmetics, tobacco products, and other related products, the Federal Trade Commission (FTC) regulates advertising and promotion of these products.  The FTC is charged with ensuring that all material claims are truthful and non-misleading, and are supported by competent and reliable scientific evidence. Recently, in response to rapidly developing markets, FTC enforcement has expanded to dietary supplements containing cannabidiol CBD, as well as nicotine-containing e-liquids, both of which tend to be marketed heavily on social media.
  • On November 5, the FTC released a short guidance document, “Disclosures 101 for Social Media Influencers”, providing direction to social media influencers—and the companies that use them for marketing—on disclosures that are needed and how to effectively disclose that a social media post is sponsored. The guidance recommends making it obvious that a financial relationship exists between the influencer and the brand he or she is promoting, through clear and conspicuous placement of the disclosure in simple language. The guidance also advises that influencers cannot make up claims (e.g., health-related claims) about a product that would require substantiation (e.g., scientific studies) that the advertiser doesn’t have.
  • In addition, advertisers and influencers alike should be aware of FTC scrutiny of claims relating to CBD products.  As recently as October 23, the FTC sent a warning letter to a company for the online marketing and sale of unapproved drug products containing CBD with unsubstantiated claims that the products treat a variety of conditions, including attention-deficit/hyperactivity disorder (ADHD), Parkinson’s, and Alzheimer’s disease. As a reminder, while the FDA has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy, the FDA has stated its commitment to evaluating potential regulatory pathways for CBD products to be lawfully marketed. We will continue to report on developments that impact the production, marketing, and sale of CBD in FDA-regulated products.

American Academy of Pediatrics Raises Concerns Re Nonnutritive Sweeteners, Calls for Research and Labeling

  • On October 28, 2019, the American Academy of Pediatrics (AAP) published a policy statement, in which it questions the effects of nonnutritive sweeteners (NNSs) on children’s health.  AAP notes that the Food and Drug Administration (FDA) currently requires manufacturers to list NNSs in a product’s ingredient statement but recommends also requiring producers to specify the amount of each NNS.  In the policy statement, AAP recommends that FDA require manufacturers to include the amounts of NNSs on product labels, “as a way to help families and researchers monitor and study children’s intake, as well as potential negative health effects.”
  • Eight NNSs are permitted in the US.  Saccharin, aspartame, acesulfame-potassium, sucralose, neotame, and advantame are cleared as food additives; an additional two NNSs, steviol glycosides and luo han guo (monk fruit extract), are the subject of Generally Recognized as Safe (GRAS) Notices.
  • The Calorie Control Council, an international association representing the low- and reduced-calorie food and beverage industry, takes issue with AAP’s claims and maintains its longstanding position that, when consumed as part of a healthy and balanced diet, the consumption of these sweeteners may serve as a tool for managing overall caloric and sugar intake.  FDA is currently reviewing AAP’s policy statement and recommendations.

President Trump Announced Intent to Nominate Dr. Stephen Hahn as FDA Commissioner

  • On November 1, President Trump announced his intent to nominate Dr. Stephen Hahn to be the new FDA Commissioner. Dr. Hahn is a radiation oncologist and currently serves as the Chief Medical Officer of MD Anderson Cancer Center in Houston, Texas. At MD Anderson, Hahn manages a $5.2 billion operating budget, 20,300 employees, 7,000 trainees and more than 3,000 volunteers. He has never served in a government post.
  • As our readers may recall, the change in FDA leadership stems from former FDA Commissioner Scott Gottlieb’s resignation in April. Gottlieb was confirmed as FDA Commissioner in May 2017 and drove several significant initiatives from food safety modernization to youth nicotine use. In April, Dr. Ned Sharpless replaced Gottlieb as Acting Commissioner of Food and Drugs. It had been assumed that Dr. Sharpless would remain the Acting Commissioner until Dr. Hahn was confirmed. However, due to the Federal Vacancies Reform Act, Dr. Sharpless’s term with the Agency expired on November 1. The Act requires that a person may not serve in an “Acting” capacity for longer than 210 days. Dr. Sharpless has since returned to his role as Director of the National Cancer Institute (NCI).
  • According to a press release from U.S. Secretary of Health and Human Services Alex Azar, Admiral Brett Giroir, Assistant Secretary for Health, will oversee the FDA, pending Dr. Hahn’s confirmation. In the press release, Secretary Azar stated that “Admiral Giroir has been an indispensable leader for HHS on a number of public health priorities. As Assistant Secretary for Health, whose authorities include overseeing the U.S. Public Health Service, he will be able to assume the delegable duties of the Commissioner at this time and ensure the FDA’s work continues to move forward.”
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