- Many, including state regulators, are closely watching the U.S. Food and Drug Administration (FDA) as it works through the challenges associated with regulating cannabidiol (CBD) products. Under the Federal Food, Drug and Cosmetic Act (FD&C Act), CBD cannot lawfully be added to a food or marketed as a dietary supplement; however, industry has been pressuring the Agency to create a pathway for the lawful use of CBD in food and dietary supplements through either an exception by regulation to the FD&C Act or through a nonenforcement policy.
- As previously reported on this blog, FDA held a public meeting on May 31, 2019 to obtain scientific data and information about the safety of FDA-regulated products containing cannabis or cannabis-derived compounds. The Agency has made clear that outstanding questions related to the safety of CBD products must first be addressed before a regulatory framework can be established for lawfully marketing foods and dietary supplements containing CBD.
- In response to FDA’s request for safety data and information, on July 16, 2019, a coalition of 37 Attorneys Generals submitted a letter to FDA, urging the Agency to cooperate with the states to protect consumer from false advertising and potential harms to their health from products containing cannabis or cannabis-derived compounds, including CBD. The letter also urged the Agency to develop ongoing assessments of potential risk and benefits of these products, including how they interact with other dietary or pharmaceutical products. Ultimately, the letter requests that FDA “ensure that states maintain a role as regulators in this emerging market.”
FSIS Publishes Tips for Label Application Submissions Amidst Evaluation Backlogs
- Meat, poultry, and egg product establishments are responsible for accurately labeling their products in conformance with regulations, guidance and policy enforced by the United States Department of Agriculture (USDA)’s Food Safety and Inspection Service (FSIS). FSIS has published a number of resources to help regulated entities navigate labeling requirements for FSIS-regulated products, including guidance documents related to labeling procedures, ingredients, claims, etc., and a number of policy memoranda and resources.
- In addition to guidance documents and policy memoranda, FSIS regularly publishes its Constituent Updates, where the Agency updates readers on its current backlog in evaluations for labels that require review and provides submission “tips” for industry to help with label application submissions. In its July 12, 2019 Constituent Update, FSIS provided guidance on voluntary modification of nutrition facts for meat and poultry establishments to meet the Food and Drug Administration’s format requirements. More recent “tips” include ensuring the application includes a label with all of the required features and documentation necessary to support any statements or claims on the label, and identifying all special statements and claims in the “Special Claims Information” section of the label application to help streamline the evaluation process.
- FSIS has put out a flurry of new policy guidelines and changes to meat and poultry labeling in recent months, including the recent guideline on labeling of “kit” products and the proposal to change net weight/net contents for meat and poultry packages. This blog will continue to monitor such developments.
FDA Publishes Final Rule on Tolerances for Animal Drugs in Food
- 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 Cheese Companies Can’t Escape Food Fraud Litigation on Excess Cellulose
- 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.
California Redefines “Beer” to Align with Federal Definition
- 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.”
WHO Recommendations on Fatty Acid Intake Challenged
- 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.”
Federal Court Not Ready to Determine Whether an Ingredient is ‘Natural’ Solely on the Basis That it is Derived From a Plant
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.
FDA Holds Ground in Challenge over GE Animal Regulatory Authority
- 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.
Updated FDA Advice on Fish Consumption for Women Who Are or Might Become Pregnant, Breastfeeding Mothers, and Young Children
- 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.
FSIS Issues Guideline on Labeling of “Kit” Products with Meat/Poultry Component
- 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.
