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 estimates how many minutes of walking or running would be needed to burn off the calories in a given product, will help combat obesity.
  • On December 10, 2019, in the Journal of Epidemiology & Community Health, UK researchers claimed that PACE labeling is a “simple strategy that could be easily included on food/beverage packaging by manufacturers, on shelving price labels in supermarkets, and/or in menus in restaurants/fast-food outlets.”  The research report stated that “public health agencies may want to consider the possibility of including policies to promote (it) as a strategy that contributes to the prevention and treatment of obesity and related diseases.”
  • UK researchers are not the first to consider PACE labeling.  In 2015, a U.S. study reported that PACE labels are an alternative way of labeling that may reduce the number of calories ordered in fast food meals while encouraging patrons to exercise.  We will continue to monitor any developments.

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. Sharpless became acting FDA Commissioner following Scott Gottlieb’s resignation as FDA Commissioner in April 2019.
  • As our readers may recall, Dr. Hahn is a professor of radiation oncology and the current Chief Medical Officer of the University of Texas MD Anderson Cancer Center in Houston, Texas. While Hahn has never served in a government post, five previous FDA commissioners and several physician and research organizations, including the American Association for Cancer Research, supported Hahn’s nomination.
  • Dr. Hahn’s confirmation comes amidst a frenzy of activity relating to vaping and e-cigarette products. During his confirmation hearing, Hahn faced questions about whether he intended to finalize FDA’s proposed ban on the sale of flavored e-cigarettes. While Dr. Hahn did not commit to a ban, he acknowledged that “this is an important, urgent crisis in this country” and that “I very much agree and support that aggressive action needs to be taken to protect our children.” Other notable topics at Hahn’s confirmation hearing included opioids and drug pricing. The final senate vote was 72 to 18.
  • In addition to the regulation of flavored e-cigarettes, as FDA Commissioner, Dr. Hahn will face several other pressing public health issues, including the regulation of food and dietary supplements containing CBD, the production and labeling of cell-based meat and plant-based alternatives, and proposed revisions to current food Standards of Identity, among others.

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 disclose any food that is or may be bioengineered.
  • Importantly, the rule’s definition of “bioengineered food” excludes foods where modified genetic material is not detectable and includes provisions for how regulated entities can use records to demonstrate that modified genetic material is not detectable, which would remove those foods from the requirement to disclose. Specifically, certain refining processes may render modified genetic material in a food undetectable, provided that the refining process is validated.
  • To ensure acceptable validation of refining processes, AMS has indicated that it will publish instructions to industry at https://www.ams.usda.gov/rules-regulations/be. We will continue to monitor the status of these instructions and will provide an update when they are published.

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 opposed to Part 110 CGMP regulations that preceded FSMA).  The old food CGMP regulations (21 CFR Part 110) were modernized under Part 117 to, among other things, make education and training of food workers mandatory, make explicit that CGMP regulations encompass allergen cross-contact, and include provisions for holding and distribution of human food by-products that are used for animal food.
  • September 17, 2018, which is the date when very small businesses were required to comply, was the latest of the staggered compliance dates for food facilities to meet all requirements of the revised CGMP regulations.  Since that time, FDA has typically posted at least two warning letters each month that cite to serious violations of 21 CFR Part 117.  Ready-to eat foods, including baked goods, ice cream, and tahini, are the products most often mentioned in FDA’s warning letters for CGMP violations.  Plant construction issues, such as poor drainage, along with pest problems (i.e., rodents and insects) are the most frequently cited violations.  Many of the most recent warning letters for CGMP violations involve environmental findings for Listeria monocytogenes, such as a November 22, 2019 warning letter to Friendly’s Manufacturing and Retail, or failure to protect against allergen cross-contact, such as an October 9, 2019 warning letter to Pollman’s Bake Shops.
  • While some of FDA’s warning letters cite to CGMP training and education deficiencies, to date we do not believe the Agency has issued any warning letters where training and education issues were the only problems with Part 117 compliance.  Of course, better training and education could prevent some of the more serious CGMP violations in the areas of plant sanitation and personnel hygiene, as are frequently cited in FDA’s warning letters,

 

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 products, and in some cases they bear impermissible drug claims, thereby rendering them unapproved new drugs that are also deemed misbranded and adulterated.
  • FDA sent a warning letter to, among others, Koi CBD LLC (Koi), referencing products such as balms, vape oils, tinctures, lotions, gummies, and beverage shots (for humans), and pet sprays and soft chews (for pets). FDA cited claims on the company’s website that CBD could be used to treat diseases and medical conditions such as various cancers, diabetes, multiple sclerosis, post-traumatic stress disorder, schizophrenia, opioid addiction, and Crohn’s Disease.
  • On December 5, 2019, plaintiffs Calley Fausett and Leigh Good filed a putative class action complaint against Koi in California federal court (Central District), alleging the company intentionally marketed and sold illegal products containing CBD. Among other things, plaintiffs allege the marketing and sale of these products constitute false, deceptive, and misleading practices and advertising; that plaintiffs would not have purchased the products (or would have paid less) had they been fully informed; and that the products lack adequate directions for use. The lawsuit is one of a growing number of private actions filed as a result of FDA’s recent warning letters that allege the use of CBD as an ingredient runs afoul of federal regulations. We will continue to monitor this case as well as other CBD-related lawsuits and regulatory actions.

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 product had they known how much was actually inside.  This week, the Seventh Circuit concluded that the plaintiffs’ request for damages was vague, as the plaintiffs did not allege that the pieces of chocolate in the boxes purchased were worth less than the amount they paid.
  • In their complaint, plaintiffs noted that Fannie May deceived consumers by packaging chocolate in boxes that contained about 33% to 40% “slack fill.”  Plaintiffs further argued that the slack fill served no functional purpose and that it only misled consumers into believing they were purchasing more chocolate than they actually were receiving.  Fannie May argued that consumers knew exactly how much product they were getting because the product label contained the net weight of the candy and a piece count.
  • The Seventh Circuit ruled that the consumers did not suffer concrete harm when they purchased allegedly underfilled boxes of chocolate.  U.S. Circuit Judge Diane P. Wood noted that this case proves that “almost anything can give rise to litigation.”  We will continue to monitor any developments involving slack fill cases.

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 produce. Our detailed summary of the rule is available here.
  • Routine inspections of small farms, other than sprout operations, subject to the Produce Safety Rule, will generally begin in Spring 2020; however, the FDA announced on December 6, 2019 that the Agency is clarifying that states receiving competition A/B funding as part of the State Produce Implementation Cooperative Agreement Program (CAP) may begin routine inspections as early as January 1, 2020.
  • This clarification is being made after several requests from states to have greater flexibility to align routine inspections with the winter growing season where applicable. Individual states will make final decisions on whether to initiate their first routine inspections of small farms at the earlier date in January 2020.

Keller and Heckman attorneys are available to assist interested parties in preparing for and navigating compliance inspections under the Produce Safety Rule. For assistance, please email: fooddrug@khlaw.com.

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 5, 2019, a New York federal judge denied class certification to a plaintiff seeking to represent all NY buyers of Pringles Salt and Vinegar chips containing an allegedly false ‘no artificial flavors’ claim because “unwieldy individual issues” predominate over common questions.  As a main issue, the court would have difficulty determining who is a class member because only 4 out of 20 of the Pringles labels contained the ‘no artificial flavors’ claim at issue.  Additionally, there are concerns that the plaintiff may not adequately represent the typical Pringles buyer because he is a chef who may have a unique interest in purchasing foods without artificial ingredients and for whom “price is no object.”  The judge also questioned whether the lawsuit was truly sought for the plaintiff’s own benefit as opposed to the benefit of the lawyers where the plaintiff was alerted to the artificial flavors by his wife, who is an attorney with one of the firms seeking to represent the class.
  • The denial of class certification in this lawsuit does not settle the merits of the false advertising claims against Kellogg Co. for Pringles made with the alleged artificial flavors, sodium diacetate and malic acid.  We have also reported on a different putative class action lawsuit over ‘natural’ claims where malic acid was alleged to be a synthetic flavor.  Lawsuits over the alleged artificial nature of malic acid and similar ingredients will not likely slow down until FDA regulates the term “natural,” an action which we have reported has been in the works for quite some time with no certain deadline.

 

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 close a “loophole” that permitted states to rely on eligibility for other programs drew the ire of 70 U.S. mayors.
  • There have been ongoing discussions of revisions to the SNAP requirements for the Able-Bodied Adults Without Dependents (ABAWD) program.  This program limits ABAWDs to receiving SNAP benefits for no more than three months within a 36-month period unless the individual (1) meets certain work requirements, (2) lives in an area with unemployment over 10 percent or (3) lives in an area that lacks sufficient available jobs.  States also have some ability to apply discretionary exemptions and to carry over unused exemptions from prior years.
  • On December 5 USDA published a final rule that will limit the definition of “area” to a labor market area (LMA), an intrastate part of a multi-state LMA, or a reservation area or a U.S. Territory.  It also defines an area as lacking sufficient jobs when a 24-month average unemployment rate is over six percent and at least 20 percent above the national rate during the same time period.  Ability to apply and carry over waivers has also been limited.  More on the new rule can be found in the USDA press release, fact sheet, and Question and Answer documents.

FDA Issues Swiss Company a Temporary Permit to Market “Ruby Chocolate” in the United States

  • On November 22, 2019, the Food and Drug Administration (FDA) announced that it had issued a temporary permit (TMP) to Barry Callebaut, a Swiss company in accordance with 21 CFR 130.17.  The TMP will allow the company to market test a product known as “ruby chocolate.”  Although the company has been selling ruby chocolate in other parts of the world, it requires a TMP from the FDA before it could call its product “chocolate” in the United States, as FDA’s standards of identity for chocolate products limit what can be labeled “chocolate.”   The FDA’s standards of identity establish the common or usual name for a food, its basic nature, and the types of ingredients that it must contain and may contain.
  • Ruby chocolate contains the principal ingredients used in most of the current standards for cacao products under 21 CFR part 163, but it deviates from existing standards of identity for chocolate in terms of its final composition, taste, and color.  FDA will not penalize a food that fails to conform to the applicable definition and standard of identity if the company who introduces the food into interstate commerce holds an effective TMP.
  • A TMP is a step towards establishing a standard of identity for ruby chocolate under FDA regulations.  The TMP allows for the temporary marketing of ruby chocolate, which will allow the Swiss company to evaluate commercial viability of the product and collect data on consumer acceptance in support of a future petition for a new standard of identity.  We will continue to monitor any developments.
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