• 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.
  • 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.

 

  • 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.

 

  • 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.
  • 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.
  • 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.”
  • PFAS, which is a catch-all term for a family of human-made substances known for their grease, water, and oil-resistant properties, are widely used in a variety of everyday products such as fabrics, cleaning products, and paints. They are also authorized for a limited number of uses in cookware and certain food packaging applications.
  • FDA has been engaged in working to develop new methods to quantify PFAS in foods and has conducted test samples of foods Americans typically consume for certain types of PFAS. In June, FDA released a statement highlighting the Agency’s efforts and outlining some of the initial results of the testing.   At that time, FDA reported that 14 of the 91 samples evaluated contained PFAS.
  • In its October 31 statement, FDA made available a scientifically validated method for testing for 16 types of PFAS in a variety of food.  After applying the validated method to the initial results, FDA said that detectable levels of certain PFAS chemicals were found in only two of 91 samples, ground turkey and tilapia. The agency will continue to analyze additional samples and make those results available this year.
  • The FDA Food Safety Modernization Act (FSMA) directs FDA to establish a program for the testing of food by accredited laboratories.  Under this program, FDA must recognize accreditation organizations that accredit food testing laboratories and adopt model accreditation standards that such laboratories must meet.
  • On November 1, 2019, FDA released a proposed rule under which FDA will recognize accreditation bodies, which will, in turn, accredit laboratories to conduct food testing.  FDA’s proposed laboratory accreditation program partially incorporates two globally recognized and widely used voluntary consensus standards, ISO/IEC 17011:2017 and ISO/IEC 17025:2017, as foundational requirements for accreditation bodies and laboratories, respectively.  Once the laboratory accreditation program is established, testing of human and animal food in certain circumstances must be conducted by an accredited laboratory and the results must be sent directly to FDA.  A full test report is required unless the testing laboratory meets FDA’s proposed provisions for submitting an abridged report.  Circumstances where testing by an accredited laboratory would be required include:

 – To comply with specific FDA testing requirements applied to address an identified or suspected food safety problem (including certain tests of shell eggs, bottled water, and sprouts);

 – To provide evidence on the admissibility of imported food (e.g., for a food that has been detained due to an appearance of adulteration);

 – To support the removal of a food from an import alert through successful consecutive testing;

 – To address an identified or suspected food safety problem and provide evidence for an informal hearing before a mandatory recall order, as part of a corrective action plan submitted after an order suspending the registration of a food facility, or as part of evidence submitted for an appeal of an administrative detention order;

 – To respond to a “food testing order,” which is a new procedure proposed by this rule to address an identified or suspected food safety problem.

  • Laboratories run and operated by federal agencies, states, localities, and foreign government entities, as well as private laboratories, including in-house laboratories, will be eligible for accreditation under FDA’s proposed program.  Laboratories could be accredited in one or more major disciplines (e.g., microbiology, chemistry, and physical testing).  FDA will establish a publicly available list of recognized accreditation bodies and laboratories accredited.  Both accrediting bodies and accredited laboratories will be subject to FDA oversight, although accrediting bodies will have primary oversight of accredited laboratories.
  • Comments on FDA’s proposed rule are due by March 3, 2020.  The laboratory accreditation program would become effective 60 days after a final rule is published; however, FDA will allow itself an unspecified time period after that to get ready to accept applications for recognition from accrediting bodies.  Then it will take more time for FDA to recognize a sufficient number of accrediting bodies so that laboratories may then apply for accreditation.  In this regard, the compliance date for testing to be conducted by an accredited laboratory participating in FDA’s program would be no sooner than six months after FDA publishes notice of sufficient laboratory capacity.  Thus, mandatory testing by an accredited laboratory appears to be a couple of years away at the earliest.
  • As previously covered on this blog, food waste is a major issue in the United States. Government estimates indicate that Americans waste between 30 and 40 percent of the overall food supply on an annual basis. According to the United States Department of Agriculture (USDA), consumers are responsible for nearly 90 billion pounds of food waste each year, which equates to 20 percent of the U.S. food supply. And while perfectly good food goes to waste, approximately 40 million Americans are food insecure.  USDA, the United States Environmental Protection Agency (EPA), and others have initiated the “Food Loss and Waste 2030 Champions” program, members of which are committing to a 50 percent reduction in food waste by 2030.
  • On October 30, the USDA, EPA, and United States Food and Drug Administration (FDA) announced a new partnership with the Food Waste Reduction Alliance (FWRA), formalizing industry education and outreach efforts with FWRA’s founding partners, the Grocery Manufacturers Association, the Food Marketing Institute, and the National Restaurant Association. The new Memorandum of Understanding is part of a larger effort from federal agencies, dubbed the Winning on Reducing Food Waste Initiative, which aims to reduce food loss and waste through community investments, education and outreach, voluntary programs, public-private partnerships, tool development, technical assistance, event participation, and policy discussion.
  • The announcement comes on the heels of ongoing Congressional efforts to address food waste, including the establishment of a House Food Waste Caucus and the introduction of legislation designed to end consumer confusion by creating a national standard for date marking of food. The USDA Food Safety and Inspection Service (FSIS) has also initiated efforts to combat food waste, including encouraging manufacturers to use labels that clearly indicate when dates refer to quality, rather than safety, in an effort to dissuade consumers from prematurely disposing of safe food products.

Last week, California’s Department of Toxic Substances Control (DTSC) hosted a webinar where it presented initial findings from its evaluation of food packaging, conducted under its Safer Consumer Products Regulations.  During the webinar, DTSC noted that it is considering the prioritization of ortho-phthalates (OPs), bisphenol A (BPA), perfluoroalkyl and polyfluoroalkyl substances (PFASs), and/or styrene in food packaging.

The goal of the Safer Consumer Products Regulations is “to create safer substitutes for hazardous ingredients in consumer products sold in California.”  Since the regulations inception in 2013, DTSC has prioritized three products:  Children’s Foam-Padded Sleeping Products with TDCPP or TCEP, Spray Polyurethane Foam Systems with Unreacted Methylene Diphenyl Diisocyanates (MDI), and  Paint or Varnish Strippers with Methylene Chloride.

To receive additional information from stakeholders, DTSC is hosting a public meeting on November 19, 2019 to discuss OPs and BPA.  In addition, DTSC will hold a workshop on PFAS and their alternatives in food packaging on January 14, 2020.