• The FDA issued warning letters to BIOTA Biosciences, LLC and Homero Corp DBA Natures CBD Oil Distribution for selling unapproved products containing cannabidiol (CBD) in violation of the Federal Food, Drug and Cosmetic Act (FD&C Act).
  • The letter issued to BIOTA cited the company for marketing injectable products containing CBD that were advertised to, among other things, “eliminate the global opioid epidemic by providing a safe and natural alternative,” “suppress pain and aid in the detoxification process,” and provide “[i]nstant relief for patients that are symptomatic of inflammatory auto-immune diseases.” The FDA asserted that the CBD products: (1) were unapproved drugs because they were intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or function of the body, and had not been approved or been generally recognized as safe, and (2) were misbranded drugs because they were not labelled with adequate directions for use by laypersons; nor could they be, since the products were not amenable to self-diagnosis and treatment by laypersons.
  • The letter issued to Homero cited the company for marketing various CBD products to both humans and animals— including topicals, oils, and edibles— that similarly claimed to treat disease, and also claimed to aid recovery from opioid addiction. In addition to asserting that the CBD products marketed for humans were unapproved and misbranded drugs, the FDA asserted that (1) CBD products could not be marketed as dietary supplements; (2) the introduction or delivery for introduction into interstate commerce of the products was a prohibited act under Section 301(ll) of the FD&C Act; and (3) the CBD edibles were adulterated foods because CBD is an unapproved food additive. The FDA also asserted that the CDB products marketed for animals constituted unapproved new animal drugs.
  • The letters demonstrate the FDA’s continued concerns regarding the safety of CBD products (see FDA’s March update on potential harms of CBD products) and the public misperception that the safety of CBD products on the market have been evaluated by the FDA.

 

 

  • State and local governments, as well as private companies, are working individually and collectively to assure an uninterrupted, safe food supply as the federal government continues in a supporting role in response to the COVID-19 pandemic.  Officials in all fifty states and four U.S. territories belong to the National Association of State Departments of Agriculture (NASDA), which for over one hundred years has worked on shaping and implementing federal food and agricultural policies and regulations.
  • NASDA’s Amanda Culp contributed an article published April 26, 2020 in Food Safety News that highlights key measures various state departments of agriculture are taking to protect the food supply.
    • All NASDA Members are working with their states’ governors and local law enforcement to assure the food and agricultural workforce stays healthy and that individuals are able to get to their jobsites.
    • State Departments of Agriculture have continued the pace of food safety, dairy, and plant inspections, and laboratory workers are adjusting work schedules to adhere to social distancing policies while assuring that food testing continues.
    • Kentucky has temporarily relaxed income requirements for receiving food from food banks and Florida has established an online list, updated daily, for Florida farmers to post produce that is available for foodbanks since the intended markets no longer exist for crops planted to supply hotels, cruise ships, and restaurants.
    • NASDA assisted the agricultural community in encouraging the U.S. State Department to expedite processing of H-2A applications and lift in-person interview requirements for both new and returning workers so that farmers have access to the needed labor.
    • Florida, Texas, Nevada, and New Jersey worked with the U.S. Department of Agriculture (USDA) on new ways to get nutritious meals to children who rely on school lunches.
    • NASDA is working to keep farmers’ markets and other forms of community supported agriculture operational.
    • States are modifying their training and certification procedures to keep pesticide applicators safe without compromising education and licensing requirements.
    • Wisconsin has taken action to protect consumers against price gouging.
    • Animal health inspections and disease response continue to operate with slight modifications that comply with Centers for Disease Control and Prevention (CDC) guidelines.
    • States are also issuing reminders to the food and agriculture community of guidance related to handwashing, social distancing, and stay-at-home orders and cautioning against hoarding food or other supplies.
  • Keller and Heckman will continue to monitor and report on the impact of the pandemic on the food industry.

 

  • FDA appears to have stepped up its enforcement of Foreign Supplier Verification (FSVP) regulations in the past several weeks, issuing four warning letters to companies in the past month for failing to have appropriate FSVP documentation in place.  FDA had issued only 10 warning letters related to FSVP compliance in the previous eight months.
  • FSVP regulations require importers to have written documentation verifying that each of its foreign suppliers is producing food in accordance with U.S. food safety standards.  As previously reported on this blog, FDA announced on April 3, 2020 that it is temporarily conducting remote inspections under the FSVP.  As is apparent from the recent warning letters, this announcement should not be regarded as an indication that FDA is slowing its enforcement of FSVP requirements.
  • Each of the firms that received FSVP-related warning letters had been inspected by FDA previously and found to not have FSVPs in place.  Each firm was issued a Form 483a with FSVP Observations; FDA issued the warning letters only after finding continuing FSVP violations on reinspection.
  • Keller and Heckman attorneys are available to assist interested parties in preparing the necessary documentation for and navigating compliance under the FSVP rule. For assistance, please email: fooddrug@khlaw.com.
  • In an April 7 letter to Vice President Mike Pence, groups including the Beer Institute, Brewers Association, National Pork Producers Council, North American Meat Institute, and National Cattlemen’s Beef Association stated that the COVID-19 pandemic created a significant risk of a shortage in carbon dioxide (CO2).  In the letter, the groups requested assistance from the federal government to prevent a “substantial CO2 shortage,” which the industry groups noted could ultimately lead to a decrease in food and beverage supply.
  • Brewers and soft-drink makers use CO2 for the carbonation of beer and soda, while meat producers use CO2 to process, package, preserve, and ship their products.  In the letter to Vice President Mike Pence, the groups stated that COVID-19 has significantly affected overall demand and production of industrial manufacturing that leads to CO2 capture.  CO2 is produced primarily as a byproduct of industrial manufacturing, including the production of ethanol.  Ethanol producers are major providers of CO2 to the food industry, as they capture gas as a byproduct of ethanol production when making renewable fuel.  Due to the decrease in number of people driving during the pandemic, the market for ethanol has declined, and U.S. ethanol plants that sell carbon dioxide have slowed production.
  • In their request to the White House, the industry groups urged the Trump Administration to provide “temporary, emergency, federal assistance by providing federal incentives to industrial manufacturers to put manufacturing plants that results in CO2 back into service.”  The industry groups stated that without stable sources of CO2 across the nation, food and beverage manufacturers will be unable to operate at capacity, which will lead to shortages for consumers during the COVID-19 crisis.
  • On April 6, Virginia Governor Ralph Northam signed a bill that defines “industrial hemp extract” as a food. Senate Bill 918, which was introduced by David W. Marsden (D-Fairfax), establishes (i) requirements for the production of an industrial hemp extract or a food containing an extract and (ii) conditions under which a manufacturer of such extract or food shall be considered an approved source. According to the bill, “food” means any article that is intended for human consumption and introduced into commerce. “Industrial hemp extract” is defined as an extract (i) of a Cannabis sativa plant that has a concentration of tetrahydrocannabinol (THC) that is no greater than that allowed for hemp by federal law (i.e., not more than 0.3% THC) and (ii) that is intended for human consumption.
  • SB 918 further authorizes the Virginia Board of Agriculture and Consumer Services to adopt regulations establishing contaminant tolerances, labeling requirements, and batch testing requirements, and it provides that money collected under the bill must be deposited in the Virginia Industrial Hemp Fund. The bill also directs the Secretary of Agriculture and Forestry to report on a plan for long-term sustainability of funding for the industrial hemp program by November 1, 2020.
  • In contrast to SB 918, at the federal level, hemp extracts, like CBD, are not eligible to be used as an ingredient in conventional foods and dietary supplements. As our readers know, on March 5, FDA released its Report to Congress, which discussed the Agency’s developments regarding the regulation of cannabinoid-containing products. Progress toward quickly providing for the lawful use of CBD in dietary supplements and conventional food is not likely, and the report makes it clear that FDA remains concerned about the risks of CBD, which include potential liver injury, interactions with other drugs, male reproductive toxicity, and side effects such as drowsiness.
  • Keller and Heckman advises clients regularly on the status of cannabinoids in FDA-regulated products. We will continue to monitor state and federal level cannabinoid-related developments.

 

  • Frank Yiannas, the FDA’s Deputy Commissioner for Food Policy and Response, answered questions regarding the current state of the U.S. food supply in a conversation published here. While acknowledging the new challenges faced by the industry during the COVID-19 pandemic, he reassured consumers that the U.S. food supply remained safe and robust.
  • Mr. Yiannis stated that shortages consumers are facing are a result of increased demand rather than a decrease in supply. He assured consumers that there was “plenty of food,” that despite some food facility closures, U.S. food production and manufacturing are widely dispersed, and that the primary challenge was diverting food to the retail market. He noted the FDA’s efforts to redirect food to the retail market including: (1) affording industry temporary labelling flexibility (blogged about here and here), (2) temporarily modifying shell egg regulation (blogged about here), and (3) providing guidance for safely distributing unused human food for use in animal food (blogged about here).
  • Mr. Yiannis also reminded consumers that there was still no evidence that food or food packaging had resulted in the transmission of COVID-19. Further, while most domestic and foreign in-person inspections have been halted (blogged about here and here), he assured consumers that the FDA was still ensuring that food was safe, including through remote inspections under the Foreign Supplier Verification Program (blogged about here) and monitoring of potential outbreaks of food-born illness.
  • Finally, while the pandemic has delayed the FDA’s plans to release a “New Era of Smarter Food Safety” blueprint in March, the FDA will continue to work toward the blueprint’s release. Indeed, the value of the blueprint’s goals —including to establish a more digital and traceable food system—will be of paramount importance in the post-pandemic world.  Keller and Heckman will continue to monitor and report on the impact of the pandemic on the food industry.

 Cheese Buyers Ask 7th Circ. to Revive Label Suit (Law360 subscription required)

  • FDA’s grated cheese regulation allows for the use of cellulose as an anticaking agent in cheese at the minimum amount necessary to prevent clumping.  As we reported in July (2019), the Illinois federal district court judge presiding over multidistrict litigation against grated parmesan companies Kraft Heinz Co. and SuperValu Inc. dismissed most of the claims alleging food fraud for excess cellulose in cheese marketed as “100% Grated Parmesan.”
  • In an April 14, 2020 brief on appeal (Law360 subscription required), the plaintiffs argue the judge erroneously decided as a matter of law that consumers would not be misled by claims on the front of the package because they could check the ingredients label on the back of the package.  The plaintiffs assert that the possibility of consumer deception in this situation is a question of fact to be decided by the jury based on the evidence.
  • The district court judge did not allow an amended complaint asserting consumer fraud based on the use of cellulose as a filler because it contradicts the initial complaint that alleged the “100% Grated Parmesan” claim is misleading because consumers did not expect any ingredient except cheese (suggesting the consumers did not read the ingredient statement which discloses the presence of cellulose “to prevent caking”).  The newly filed brief does not squarely address whether arguments that cellulose is used as a filler can be made to support the dismissed claims that require showing reliance on misrepresentations in making the purchase.
  • On April 8, 2020, a California federal judge dismissed a putative class action complaint challenging Ghirardelli Chocolate Co.’s labels on its cocoa-free white baking chips. Cheslow, et al. v. Ghirardelli Chocolate Co., Case No. 19-cv-07467-PJH, 2020 U.S. Dist. LEXIS 62044 (N.D. Cal. Apr. 8, 2020).
  • Plaintiffs asserted they purchased Ghirardelli’s “Premium Baking Chips Classic White Chips” under the impression that they contained “real” white chocolate, and that the product label, advertising, and marketing (including use of the term “premium”; references to “white” chips; and inclusion (until at least June 2019) of the term “chocolate” on product packaging and website) would mislead and deceive a reasonable consumer to believe the product contained “real” white chocolate.  Plaintiffs alleged that due to the absence of cocoa butter/cacao fat, however, and the use of purportedly inferior ingredients such as hydrogenated and palm oils, the product contains “fake” white chocolate instead.
  • Judge Phyllis J. Hamilton (Northern District of California) granted Ghirardelli’s motion to dismiss, noting, among other things: the words “chocolate” and “cocoa” did not appear anywhere on the product label, at the time of the order (other than as part of Ghirardelli’s logo, which did not apply); the word “white” in “White Chips” defined the color of the food and not the quality of the product (“white wine may define the characteristic of the wine’s color but does not inform the consumer whether the wine is a zinfandel or gewürztraminer”); and the use of “premium” constituted mere puffery.
  • While the motion was dismissed without prejudice and plaintiffs were granted leave to amend their complaint, Judge Hamilton noted that
    “[b]ecause defendant’s product packaging would not change in an amended complaint, the court is skeptical that the complaint can be amended to state a claim.”
  • On April 2, 2020, the Alcohol and Tobacco Tax and Trade Bureau (TTB) issued a final rule, which modernizes labeling and advertising regulations for wine, distilled spirits, and malt beverages.  The final rule is effective May 4, 2020.
  • The final rule gives companies flexibility on the placement of mandatory information on distilled spirits labels.  The final rule will allow information, like brand name, class and type of the distilled spirit, alcohol content, and net contents (for containers that do not meet a standard of fill) to appear anywhere on the label, as long as all mandatory information can be viewed simultaneously, without the need to turn the container.
  • The rule also amended regulations that govern specific distilled spirits, like Tequila and Vodka.  For example, the rule created, within the standards of identity, a class called “Agave Spirits,” and two types within that class: “Tequila” and “Mezcal.” Previously, regulations provided a standard for only “Tequila.”  TTB believes that the creation of the ‘‘Agave Spirits’’ class will provide more information to consumers and will allow industry flexibility when labeling products that are distilled from agave.  In regard to Vodka, TTB removed the requirement that vodka be without distinctive character, aroma, taste, or color.
  • TTB’s final rule also affects malt beverages, like beer.  Previously, TTB prohibited “strength claims” on beer labels and in beer advertisements; however, TTB will now authorize such labeling and advertising.  As such, the use of words like “strong,” “full strength,” and “extra strength” will now be allowed.  Per this final rule, TTB will also now allow “other truthful, accurate, and specific factual representations of alcohol content, such as alcohol by weight” to “appear on the label, as long as they appear together with, and as part of, the statement of alcohol content as a percentage of alcohol by volume.”  Thus, brewers will be able to use the same label in states that require alcohol content to be stated as a percentage of alcohol by weight, and in other states that neither require nor prohibit alcohol by weight statements.
  • On April 11, Virginia Governor Ralph Northam vetoed a bill that would have limited the use of the term “milk.” HB 119 was introduced to the Virginia House on December 16, 2019 and defined “milk” as “the lacteal secretion of a healthy hooved mammal and provides that a food product is unlawfully misbranded if its label states that it is milk and it fails to meet such definition, except for human breast milk.” The bill directed the Board of Agriculture and Consumer Services to implement a plan to ban all products misbranded as milk.
  • Governor Northam explained his decision to veto by stating that “[e]liminating the ability to label certain food products with the term “milk” could hinder some businesses’ ability to thrive in Virginia. This bill likely conflicts with both the United States Constitution and the Constitution of Virginia and each’s protection of commercial speech. Accordingly, I veto this bill.”
  • As our readers are aware, since 2018, dozens of states have introduced similar labeling bills, many of which have been challenged in court. On the federal level, U.S. Senator Tammy Baldwin introduced the Dairy Pride Act in March 2019 to prohibit non-dairy products made from nuts, seeds, plants, and algae from being labeled with dairy terms like milk, yogurt, and cheese. Although it has yet to be referred out of committee. Additionally, the FDA requested comments on the use of dairy terms, such as milk, yogurt, and cheese, in the labeling of plant-based products. FDA received 14,000 comments but has yet to act further.