• On July 10 FDA finalized its rule on Updating Tolerances for Residues of New Animal Drugs in Food.  This rule was originally proposed in 2012 with a revision proposed in 2016.  The rule will become effective September 9.
  • As described in the Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) Update, the new rule does not set new tolerances, but it does standardize and clarify “the standards for determining, codifying, and updating tolerances, and [it] also provides a definition section of key terms that the FDA uses in the determination of tolerances.  This final rule will enhance understanding of tolerance determination and improve the overall readability of the relevant regulations.”
  • This rule follows in the footsteps of the Guidance on Evaluating Animal Drug Safety in Food-Producing Animals and the Strategy for Antibiotic Stewardship in Food Animal Production in FDA’s continued interest in ensuring that drugs are used to treat animals for food in a way that is protective of human health.
  • Grated parmesan companies Kraft Heinz Co. and SuperValu Inc. have not been able to end multidistrict litigation that began in 2016, alleging food fraud for excess cellulose as an anticaking agent.  While the defendants argue that the cellulose acted as an anticaking agent, plaintiffs allege that the cellulose was being used as a filler in the cheese marketed as “100% cheese.”
  • A federal district court judge in Illinois has denied (Law360 subscription required) Plaintiff’s attempt to amend their complaints to reintroduce previously dismissed defendants, Publix and Target/ICCO.  The judge also dismissed state law claims requiring plaintiffs to demonstrate that they relied on misrepresentations to make their purchases because of the plaintiff’s deficient pleadings.  However, other state consumer protection claims that do not have the same reliance requirement have been allowed to proceed because the pleadings were sufficient for such claims.
  • While FDA’s grated cheese regulation allows for companies to add cellulose as an anticaking agent in cheese to prevent clumping, using more than the minimum amount required to achieve the anticaking effect presents the possibility of a food fraud allegation.  For more information on food fraud and other litigation risks, check out our Practical Food Law Seminar happening in Brussels on October 2-3, 2019.
  • On July 9, 2019, California Governor Gavin Newsom signed into law Assembly Bill (AB) 205, which redefines beer under California’s Alcohol Beverage Control Act.  AB 205 allows for beer to be produced with honey, fruit, fruit juice, fruit concentrate, herbs, spices, and other food materials. Under the prior California law, “beer” was defined as “any alcoholic beverage obtained by the fermentation of any infusion or decoction of barley, malt, hops, or any other similar product, or any combination thereof in water.” Prior to AB 205, use of fruit in the fermentation process required a wine license.
  • Notably, federal law already permits the use of these additional ingredients.  As per 26 U.S.C. § 5052(a), federal law defines beer as “beer, ale, porter, stout, and other similar fermented beverages (including sake or similar products) of any name or description containing one-half of 1 percent or more of alcohol by volume, brewed or produced from malt, wholly or in part, or from any substitute therefor.” Federal regulations at 27 CFR 25.15 identify the materials that may be used in the production of beer: “Beer must be brewed from malt or from substitutes for malt. Only rice, grain of any kind, bran, glucose, sugar, and molasses are substitutes for malt. In addition, you may also use the following materials may be used as adjuncts in fermenting beer: honey, fruit, fruit juice, fruit concentrate, herbs, spices, and other food materials.”
  • Thus, the passage of AB 205 is a seemingly long-overdue update and will likely have little effect on the market as California’s legal system has likely deferred to the federal definition.  Indeed, California Craft Brewers Association Executive Director Tom McCormick described AB 205 as a “clean-up bill” that aligns California with federal law. Nonetheless, Assemblyman Tom Daly (D-Anaheim), who introduced the bill, stated that “[t]his measure modifies the definition of beer in a way that will allow California breweries to expand their market, satisfying the consumer’s desire for more varied and unique styles of beer.”
  • As previously reported on this blog, the World Health Organization (WHO) released draft guidelines on saturated fatty acid and trans-fatty acid intake for adults and children in 2018. The draft guidelines recommend reducing total intake of saturated fat and trans-fatty acids, and consuming polyunsaturated fatty acids as a source of replacement energy. The objective of the recommendations is to reduce the risk of noncommunicable diseases.
  • A group of international researchers have called on WHO to take a different approach with respect to its recommendations for saturated fatty acid intake. In a British Medical Journal article, published July 3, the researchers said that the recommendations “fail to take into account considerable evidence that the health effects of saturated fat varies depending on the specific fatty acid and on the specific food source.”
  • The researchers suggest that since not all saturated fatty acids are equal and that the food matrix in which they exist is an important factor in determining their effect on cardiovascular disease, “[m]aintaining general advice to reduce total saturated fatty acids will work against the intentions of the guidelines and weaken their effect on chronic disease incidence and mortality,”
  • Noting that WHO guidelines have potential health implications for billions of people, the researchers stress that the guidelines on saturated fat “should consider different types of fatty acids and, more importantly, the diversity of foods containing saturated fatty acids that might be harmful, neutral, or even beneficial in relation to major health outcomes.”

 LaCroix’s ‘Outraged’ Sanctions Bid in ‘Natural’ Suit Falls Flat (Subscription to Law360 required)

  • The named plaintiff in a class action lawsuit filed in Illinois last year (Rice v. National Beverage Corp. d/b/a LaCroix Sparkling Waters, October 18, 2018) alleges that “all natural” labeling on LaCroix sparkling water is fraudulent because the sparkling water contains chemicals such as ethyl butanoate, limonene, linalool, and linalool propionate, which the plaintiff alleges are synthetic.  The defendant manufacturer, National Beverage Corp., had the case removed to federal court and answered the complaint (denying the allegations) before seeking sanctions under Federal Rule of Civil Procedure (“Rule”) 11 for an allegedly frivolous complaint.
  • In addition to ruling against National Beverage Corp. on procedural grounds (i.e., unsanctionable state court conduct cannot be brought within the scope of Rule 11 by the plaintiff’s answering a motion to dismiss), the court also found the defendant failed to substantiate arguments that the lawsuit is frivolous.  Regarding National Beverage Corp.’s assertion that 21 CFR 182.60 (“Synthetic flavoring substances and adjuvants”) refers only to synthetic versions of the listed compounds, and not to naturally derived versions of the substances, the court found “nothing obviously misguided and unreasonable about plaintiff’s view of what the regulation asserts, that two substances used in defendant’s sparkling water, limonene and linalool, are synthetic.”
  • As previously noted on this blog, the lawsuit against LaCroix and other cases that are centered on the use of “natural flavors” signify a new focus of scrutiny for plaintiff’s lawyers.  A critical issue for resolution is whether the degree of processing and not just plant derivation is what distinguishes a synthetic from a natural substance and, if so, what level of processing brings an ingredient outside of the realm of ‘natural.’  That issue has not yet been addressed in this case but presumably will need to be as the lawsuit progresses.

 

  • As previously reported on this blog, on June 11, the President issued Executive Order Modernizing the Regulatory Framework for Agricultural Biotechnology Products, ensuring coordination across federal regulatory agencies for biotechnology products. Referring to gene-edited crops and animals, the executive order told regulators to use their existing powers “to exempt low-risk products of agriculture biotechnology from undue regulation.”
  • Currently, FDA regulates these animals under the “new animal drug” provisions of the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations for new animal drugs. FDA has only approved one GE animal, the AquAdvantage Salmon in 2015 after determining that it met the statutory requirements for safety and effectiveness under the Federal Food, Drug, and Cosmetic Act.
  • Shortly after the release of the June 11 Executive Order noted above, the National Pork Producers Council (NPPC) put out a “Keep America first in agriculture” platform that states that “under FDA regulation, gene editing [in American livestock] faces an impractical, lengthy and expensive approval process.” The NPPC has called for regulatory oversight of GE animals to shift to USDA, arguing that it already has a review process in place for genetic editing in plants under its Animal and Plant Health Inspection Service.
  • As reported, FDA has pushed back against the NPPC call for USDA to take control over the regulation of GE animals. Steve Solomon, director of FDA’s Center for Veterinary Medicine, said the agency has the right framework and expertise after decades of reviewing biotech applications and building teams that are steeped in the science. Whether and how the hog industry continues to challenge FDA’s authority over the regulation of GE animals remains to be seen.

 

 

 

  • On July 9, 2019 the Food and Drug Association (FDA) announced the availability of “Advice about Eating Fish: For Women Who Are or Might Become Pregnant, Breastfeeding Mothers, and Young Children.”   The update follows a 2019 congressional directive mandating that the original 2017 version, “Advice about Eating Fish,” be updated in a manner consistent with current nutrition science recognized by FDA.
  • The revised advice includes statements that eating fish while pregnant or breastfeeding can provide health benefits that help children’s growth and development—highlighting choices that are lower in mercury. It also states that fish consumption may offer heart health benefits and may lower the risk of obesity.
  • FDA is accepting public comments on the updated advice until September 9, 2019.
  • On July 9, 2019, USDA’s Food Safety and Inspection Service (FSIS) issued a notice of availability and a request for comment on a new guideline for kit products that contain a meat or poultry products.  84 FR 32705.  The guideline is available here. Specifically, the guideline addresses the circumstances in which the assembly of a “kit product” that contains meat or poultry needs to be done under FSIS inspection and the labeling required for these products. This is the first time the Agency has addressed this topic via formal guidance.
  • A “kit product” consists of individually-packaged food components sold together as a single unit, such as pizzas, salads, fajitas, wraps, meals, etc. that contain a meat or poultry component.  FSIS guidelines state that the act of assembling a kit product that contains meat or poultry does not need to be done under FSIS inspection if the following conditions are met:
    • The meat or poultry component is prepared and separately packaged under FSIS inspection and labeled with all required features;
    • The outer kit label identifies all of the individual components in the kit; and
    • The outer kit label clearly identifies the product as a single unit or “kit,” such as “Chicken BBQ Dinner Kit” and “Beef Lasagna Meal.”
  • Comments on the guideline are due by September 9, 2019.  In its notice, FSIS states that once it assesses comments, the Agency will issue instructions to the Office of Field Operations to clarify what products constitute kits that should no longer be under inspection.
  • During the past month, the governors of Vermont, Maine, Oregon, Delaware and Connecticut signed legislation banning single-use plastic bags and a few months earlier, on April 22, New York’s governor signed similar legislation.
  • New York’s plastic bag ban is scheduled to take effect on March 1, 2020. The law bans most single-use plastic carry-out bags provided by grocery and other stores unless they are exempted. Exemptions include bags used to wrap uncooked meat, fish or poultry; bags to hold food prepared to order; bags used by a customer for bulk items (e.g., fruits and vegetables); bags for carryout or delivered food; and food storage bags. The legislation also allows individual counties to charge five cents for paper bags.
  • Maine’s H.P. 1115 (LD 1352) bans retail establishments from providing customers with most single-use plastic bags, effective January 1, 2020. The legislation lists a number of exemptions, such as bags for prescription medication, bags for use within a store to package loose items, and dry-cleaning bags. Retail establishments may provide a recycled paper bag of reusable plastic bag for a fee of at least five cents per bag.
  • Oregon’s HB 2509 bans retail establishments and restaurants from providing customers single-use checkout bags. Certain bags are exempted, such as bags for produce, meat, fish and dry cleaning. Stores may provide paper checkout bags, reusable fabric checkout bags, or reusable plastic checkout bags for at least five cents each. The ban becomes effective in January 2020.
  • Vermont’s Act No. 69 (S.113) prohibits stores and food establishments from providing single-use plastic bags, effective July 1, 2020. Pharmacy bags for prescription medication; bags used inside a store to package loose items, frozen foods, meat, fish or flowers; and dry-cleaning bags are exempted. The legislation also prohibits food service establishments from providing single-use plastic straws unless requested and bans the sale of expanded polystyrene food service products.
  • Delaware’s HB 130 bans bags that are “made from non-compostable plastic and not specifically designed and manufactured to be reusable” effective January 1, 2021. Exceptions include plastic bags to wrap damp items like frozen foods, bags to transport chemicals, and dry-cleaning bags.
  • Single-use plastic grocery bag are currently banned in California and Hawaii. California has had a statewide plastic bag ban in place since late 2016 and, plastic grocery bags are banned in all counties in Hawaii.
  • Adequate toxicological data – often involving the sacrifice of laboratory animals – are necessary for reaching a safety decision on the products that are subject to FDA’s regulatory review.  FDA’s Predictive Toxicology Roadmap, published in December 2017, is a six-part framework for integrating predictive toxicology methods into the Agency’s safety and risk assessments.  FDA’s initial public workshop on the Roadmap, held September 12, 2018, covered human tissue on a computer chip and other  new technologies already used in industry that support animal 3Rs (Replacement, Reduction, and Refinement).  FDA also highlighted new and revised guidance documents that have incorporated some of the new toxicology approaches.
  • On Wednesday, September 18, 2019, FDA will host another public workshop, Implementing FDA’s Predictive Toxicology Roadmap: An Update of FDA’s Activities, to highlight recent work.  While much of the new technology is being developed with a focus on drug screening and toxicity testing, a number of predictive modeling approaches may also be applicable to other FDA-regulated industries such as food and tobacco products.  For example, the agenda for the 2019 Roadmap workshop features experts from FDA’s Center for Food Safety and Applied Nutrition (CFSAN) speaking on topics including Tox21, EU ToxRisk, and FDA’s application of an expanded decision tree and the threshold of toxicological concern (TTC) approach for safety assessment.
  • Interested parties may attend the Roadmap workshop in person or via Adobe Connect.  Attendees must register by Monday, September 16, 2019.