• On August 3, 2020, New York Governor Andrew Cuomo signed legislation S7013/A8732, allowing the sale of liquor-infused ice cream in the state.  S7013 amends New York’s agriculture and markets law, public health law, and alcoholic beverage control law, in relation to authorizing the manufacture and sale of ice cream and other frozen desserts made with  liquor.  The law applies to sealed packages of ice cream made by dairy processors and manufacturers, liquor and craft beverage producers, restaurants, and other food retailers.
  • The measure would limit the percentage of alcohol in ice cream to not more than five percent of alcohol by volume (ABV) and would require the same product labeling and warning statements similar to confectionery that contain wine, beer, or cider.  By way of background, ice cream containing wine, beer or hard cider was already legal in the state.  Further, the law notes that ice cream, and other frozen desserts, made with wine, beer, or cider with an alcohol content of no more than five percent ABV is not considered an alcoholic beverage.
  • The law requires manufacturers or distributors to include statements, including “the sale of this product to individuals under the age of twenty-one years is prohibited” and “this product is made with (insert liquor, wine, beer and/or cider) and contains alcohol up to five percent by volume.”  Moreover, these products will need to include warnings such as “this product contains alcohol used as a flavoring and, as with any product that contains alcohol: (1) women should not consume alcohol during pregnancy because of the risk of birth defects, and (2) consumption of alcohol impairs your ability to drive a car or operate machinery, and may cause health problems.”
  • In an August 3, 2020 press release, Governor Andrew Cuomo stated that “the craft beverage industry has experienced explosive growth in New York and with that comes a responsibility to advance regulations that help ensure long-term viability, protect consumers and provide farmers with opportunities to increase their business.”
  • The FDA’s Food Safety and the Coronavirus Disease Guidance  (the “Guidance”) is a resource for the food industry as it responds to the COVID-19 pandemic. On July 29, 2020, the FDA updated the page to include a section on considerations for U.S. exporters of FDA-regulated food products.
  • While cautioning that U.S. exporters are responsible for following the requirements of the countries to which they export (in addition to U.S. laws and regulations), the updated guidance reiterates that, despite the request from some countries for “commitments to provide information that food is free of the COVID-19 virus and/or has been produced under conditions that prevent contamination by the COVID-19 virus,”  there is no evidence of COVID-19 transmission in food or food packaging and that the FDA does not anticipate the need to recall food products because of COVID-19. (For media coverage of such requests from Chinese authorities, see here). In response to these requests, the guidance (1) states that the FDA is communicating its understanding of the science of COVID-19 transmission and food safety to foreign governments, (2) recommends that U.S. exporters distinguish between official food safety requirements and business requests, and (3) encourages exporters to use FDA’s COVID-19 resources when interacting with foreign countries.
  • The foreign country requests highlight the importance of following the COVID-19 best practices laid out in the Guidance (and linked documents), including frequently disinfecting surfaces, checking workers temperatures, and ensuring that workers are socially distanced.  Keller and Heckman will continue to monitor and report on COVID-19 related developments that impact the food industry.
  • In the United States between 2009 and 2018, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) identified 40 outbreaks of food-borne illness with a confirmed or suspected link to leafy greens and Shiga toxin-producing E. coli (STEC).  Although agricultural water is one of the main vehicles through which leafy greens and other produce can become contaminated with E. coli O157:H7 and other foodborne pathogens, there are no antimicrobial treatment products registered with the Environmental Protection Agency (EPA) for use in agricultural water sources.
  • On July 30, 2020, FDA announced the release of a new testing protocol, formed in partnership with EPA, to facilitate companies’ efforts to develop and register antimicrobial products designed to treat preharvest agricultural water.  The protocol was first revealed during an FDA Center for Food Safety and Applied Nutrition webinar on its 2020 Leafy Greens STEC Action Plan, and was introduced as a way to address the identified need to further protect agricultural water sources from pathogen contamination.  The new protocol establishes an agricultural water panel assay that companies can use to test the capability of their water treatment products to combat strains of Listeria, Salmonella, and E. coli frequently responsible for foodborne illnesses.  EPA’s endorsement of this protocol enables companies that follow its steps to use the testing data generated to support an application for registration of new products or to revise the labels of existing products as being for use against microbial contamination in preharvest agricultural water.
  • FDA cites the new EPA-approved protocol for evaluating the efficacy of antimicrobial pesticides in agricultural water as an important prevention step towards food safety, taken as part of its Leafy Greens STEC Action Plan and New Era of Smarter Food Safety Initiative (which includes a 10-year blueprint released on July 13, 2020, as discussed here).
  • On July 28, 2020, a New York federal judge dismissed class action claims against Oreo maker Mondelez Global LLC that accused the company of misleading consumers with “always made with real cocoa” labels on its Oreo packaging.
  • Plaintiffs from 12 states filed suit in April 2019, accusing Mondelez of misleading consumers because the cocoa used in Oreos is “highly processed and modified” with alkali.  Based on the Oreo labels, plaintiffs claimed that a reasonable consumer would expect unadulterated cocoa.  Plaintiffs further claimed that alkalized cocoa does not have the health benefits that consumers expect from “real cocoa.”
  • U.S. District Judge Edward R. Korman dismissed the class action and held that plaintiffs failed to show that Mondelez misrepresented cocoa content on the labels.  Rather, the judge held that the assertion that Oreos are made with diluted cocoa does not negate the fact that the cookies were made with real cocoa, even if mixed with another ingredient.  This is not the first case challenging alkalized cocoa and “real”/”simple”/”natural” claims and is not likely to be the last.
  • In a July 29, 2020 news release, the U.S. Food and Drug Administration (FDA) announced that it had issued warning letters to seven companies for illegally selling unapproved products labeled as dietary supplements that claim to cure, treat, mitigate or prevent hangovers, which is in violation of the Federal Food, Drug, and Cosmetic Act (“FD&C Act”).
  • In the letters to the seven companies, FDA noted that the claims on the products’ websites establish that the products are drugs under the FD&C Act because they are “intended for use in the cure, mitigation, treatment, or prevention of disease.”  By way of background, under the FD&C Act, products intended to cure, treat, mitigate, or prevent disease are considered drugs and are subject to the requirements that apply to drugs.  FDA stated that a statement claims to mitigate, treat, cure, or prevent disease if it claims, explicitly or implicitly, that the product has an effect on the characteristic signs or symptoms of a specific disease or class of diseases, such as a hangover, which FDA described as “a sign or symptom of alcohol intoxication, a disease.”
  • In the warning letters, FDA noted that claims like “Ultimate Hangover Relief,” Protect your liver and brain,” “the most effective hangover preventing supplement currently available,” and “Helps prevent hangover symptoms” claim to mitigate, treat, cure, or prevent disease.  FDA warned that hangover products are not generally recognized as safe and effective for the proposed uses.  Therefore, the Agency concluded that these products constitute new drugs and that new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA.
  • On July 24, 2020, the US House of Representatives passed a four-bill minibus that set FDA’s fiscal year 2021 budget at $3.212 billion – a $40.8 million increase over last year’s allocation. The budget increase comes alongside a set of new policy priorities, detailed in the House Appropriations Committee’s minibus summary.
  • The bill would, for the first time ever, grant FDA mandatory recall power over prescription and over-the counter drugs. It also includes funding to develop a regulatory framework for cannabidiol (CBD), to increase medical product and food safety activities, and to investigate new influenza vaccine manufacturing technologies. The bill provides funding for an FDA program that would “identify, detain, and refuse the import of FDA-regulated products from a foreign establishment that did not allow physical access to FDA investigators.” It also contains “a strong focus” on combating foodborne illness and protecting the cybersecurity of medical devices.
  • Elsewhere, the bill allocates funds to USDA, including increased spending for nutritional programs, food safety and inspection programs, and agricultural research. The bill’s next stop is the US Senate, where action is needed by the start of the new fiscal year (October 20, 2020). If the Senate fails to pass the bill in time, these agencies will need to begin the fiscal year with funding from a Continuing Resolution. Keller and Heckman will continue to monitor developments on FDA and USDA funding.
  • On July 16, 2020 the FTC published a notice of proposed rulemaking in which it announced its intention to codify its long-time enforcement policy regarding products labeled as “Made in the USA” (MUSA); these claims are currently enforced through the FTC’s general authority to prevent unfair and deceptive practices.
  • The proposed rule does not change the substantive criteria on which such claims will be evaluated and rather is primarily intended to (1) strengthen the FTC’s enforcement mechanism by making it easier for the FTC to assess civil penalties against those making unlawful MUSA claims and (2) give marketers more regulatory certainty. Under the proposed rule, a MUSA claim may, as before, only be made where (1) the final processing or assembly occurs in the USA, (2) all significant processing that goes in the product occurs in the USA, and (3) all or virtually all of the ingredients or components of the product are made and sourced in the U.S. While the proposed rule would apply to a broad range of product labels, it would also apply to MUSA claims found outside of the product label such as mail order catalogs and mail order promotional materials defined to include “any materials, used in the direct sale or direct offering for sale of any product or service, that are disseminated in print or by electronic means, and that solicit the purchase of such product or service by mail, telephone, electronic mail, or some other method without examining the actual product purchased.”  The proposed rule would not apply to qualified MUSA claims.
  • Comments to the proposed rule are due by September 14, 2020. The proposed rule is also covered in our Consumer Protection Connection blog post. Keller and Heckman will continue to monitor the proposed rule for any developments.

 

 

  • A December 21, 2018 final rule by the Agricultural Marketing Service (AMS) of the United States Department of Agriculture (USDA) established the National Bioengineered Food Disclosure Standard (NBFDS), as discussed here.  The NBFDS regulations include a List of Bioengineered Foods (the List) that AMS has determined are currently in legal production somewhere in the world.  Items on the List are presumed to potentially require a bioengineered (BE) food disclosure unless records demonstrate the item used is not bioengineered.  A BE food disclosure may be required for a food that is not on the List only if the regulated entity has actual knowledge that it is bioengineered.
  • On July 24, 2020, AMS took action to update the List by recommending the addition of a new crop, ‘‘Sugarcane (insect-resistant),’’ based on the determination that in 2018, Brazil approved commercial production of BE sugarcane developed to resist borer infestations using recombinant DNA technology and in the 2018/2019 crop year, approximately 4,000 hectares were planted for commercial production.  Additionally, in keeping with a policy of including a modifier when only one BE trait is available, AMS has proposed to include the modifier “(insect-resistant)” for an already listed crop, “Squash (summer).”
  • The addition of ‘‘Sugarcane (insect-resistant)’’ to the List may complicate the strategy of regulated entities wishing to alleviate NBFDS burdens by avoiding “Sugarbeet,” which is currently listed generically based on availability of more than one BE version.  Comments on the proposed updates to the List are due by August 24, 2020.  The mandatory date for compliance with the NBFDS is January 1, 2022.
  • The U.S. Food and Drug Administration (FDA) has issued a final Compliance Policy Guide (CPG), Sec. 540.750, on the “Use of The Seafood List to Determine Acceptable Seafood Names.”  The Seafood List is FDA’s guide to acceptable market names for domestic and imported vertebrate and invertebrate seafood sold in interstate commerce.  The Seafood List provides information on the proper labeling of seafood and products containing seafood ingredients, such as in the statement of identity and ingredient list.  In addition, FDA’s Seafood List Guidance (“Guidance for Industry: The Seafood List – FDA’s Guide to Acceptable Market Names for Seafood Sold in Interstate Commerce”) provides guiding principles to determine the acceptable market name for a new seafood species introduced into the marketplace and defines the various categories of names in the Seafood List (acceptable market name, common name, scientific name, and vernacular name).
  • The CPG (guidance directed towards FDA staff that also informs industry of FDA’s interpretations of policy on regulatory issues) is intended to be used together with the Seafood List and Seafood List Guidance, upon consultation of existing standards of identity, FDA statutes, regulations, and other CPGs (e.g., CPGs specifically addressing snapper and caviar), in an effort to reduce or eliminate mislabeled and misbranded products in the marketplace.
  • The CPG finalizes a draft version issued in November 2016, and includes updated language, such as guidance acknowledging that the United States Department of Agriculture’s Food Safety and Inspection Service (USDA FSIS), through its mandatory inspection program, regulates fish of the order Siluriformes, including catfish and products derived from catfish.  The CPG also discusses potential enforcement actions that may be taken and provides specimen charges relating to domestic seizure and import refusal.  Finally, it provides regulatory action guidance to FDA’s field staff in an effort to address misbranding violations and clarifies acceptable names for labeling seafood species.
  • On July 21, 2020, the U.S. Food and Drug Administration (FDA) announced in a letter of enforcement discretion that it does not intend to object to the use of certain qualified health claims regarding consuming certain cranberry products and a reduced risk of recurrent urinary tract infection (UTI) in healthy women.  FDA’s letter was in response to a health claim petition submitted on behalf of Ocean Spray Cranberries, Inc.  The petitioner requested that FDA authorize a health claim regarding the relationship between the consumption of cranberry products and the reduced risk of recurrent UTI in healthy women.  By way of background, a health claim characterizes the relationship between a substance and a disease or health-related condition.
  • FDA concluded that there is limited and inconsistent credible scientific evidence to support a qualified health claim for the consumption of cranberry juice beverages, and limited credible scientific evidence to support a qualified health claim for the consumption of cranberry dietary supplements and a reduced risk of recurrent UTI in healthy women.
  • In its response to the petition, FDA noted that it will exercise its enforcement discretion regarding claims for the association between consumption of cranberry juice beverages containing at least 27 percent cranberry juice and cranberry dietary supplements containing at least 500 milligrams (mg) of cranberry fruit powder (100% fruit) and a reduced risk of recurrent UTI.   FDA noted that the claims do not include other conventional foods or food products made from or containing cranberries, such as dried cranberries or cranberry sauce.
  • The following qualified health claims for cranberry juice beverages are included in the FDA’s letter of enforcement discretion:
    • “Limited and inconsistent scientific evidence shows that by consuming one serving (8 oz) each day of a cranberry juice beverage, healthy women who have had a urinary tract infection (UTI) may reduce their risk of recurrent UTI.”
    • “Consuming one serving (8 oz) each day of a cranberry juice beverage may help reduce the risk of recurrent urinary tract infection (UTI) in healthy women. FDA has concluded that the scientific evidence supporting this claim is limited and inconsistent.”
    • “Consuming one serving (8 oz) each day of [this identified cranberry juice beverage] may help reduce the risk of recurrent urinary tract infection (UTI) in healthy women. FDA has concluded that the scientific evidence supporting this claim is limited and inconsistent.”
  • The following qualified health claims for cranberry dietary supplements are included in the FDA’s letter of enforcement discretion:
    • “Limited scientific evidence shows that by consuming 500 mg each day of cranberry dietary supplement, healthy women who have had a urinary tract infection (UTI) may reduce their risk of recurrent UTI.”
    • “Consuming 500 mg each day of cranberry dietary supplement may help reduce the risk of recurrent urinary tract infection (UTI) in healthy women. FDA has concluded that there is limited scientific evidence supporting this claim.”
    • “Consuming 500 mg [X capsules/tablets/soft gels] each day of [this identified cranberry dietary supplement] may help reduce the risk of recurrent urinary tract infection (UTI) in healthy women. FDA has concluded that there is limited scientific evidence supporting this claim.”