• On March 16, 2020, the Consumer Brands Association (CBA) submitted a letter to the U.S. State Department and the Office of the U.S. Trade Representative asking for an increase in protections against other countries hoarding materials required to make products that keep American consumers healthy, such as food, hygiene, and cleaning materials.  Moreover, CBA also requested that the federal government exempt manufacturing facilities from Center for Disease Control and Prevention gathering limits, which ban the gathering of more than 50 people.
  • In the letter, CBA noted that it fears that countries may wish to restrict the export of base materials, nutritional and food inputs, chemicals and other essential manufacturing supplies and ingredients, which will prevent U.S. manufacturers from increasing production. Ultimately, CBA stated that this may lead to consumers being unable to obtain products that are vital to treating and stopping the spread of COVID-19.  CBA also highlighted that other counties, like India, Germany, France, the Czech Republic, Turkey, and Russia, have already implemented restrictions on exports of chemicals, medical supplies and other materials.
  • Last week, CBA also wrote a letter to Attorney General William Barr requesting that there be protections from price gouging of consumer packaged goods due to the coronavirus. We will continue to monitor this issue.
  • As previously  covered on this blog, FDA issued final rules in May 2016 to implement changes to the nutritional labeling and serving size regulations.  For manufacturers with $10 million or more in annual food sales, the compliance deadline was January 1, 2020.  Manufacturers with less than $10 million in annual food sales have until January 1, 2021 to comply.
  • On March 11, 2020, FDA launched an education campaign  to raise awareness concerning changes to the label and help consumers learn to use the nutrition labels as a tool for healthy dietary practices.
  • The campaign, titled “The New Nutrition Facts Label: What’s in it for You?”, includes outreach through social media, videos, downloadable educational material, and indoor/outdoor advertising.  This campaign is part of FDA’s Nutrition Innovation Strategy that seeks to reduce preventable death and disease associated with poor nutrition.
  • The ongoing spread of the novel coronavirus has prompted the U.S. Food and Drug Administration (FDA) to postpone most foreign inspections of manufacturing facilities.  On March 10, 2020, the FDA provided an update on the status of FDA inspections outside of the U.S. in response to the COVID-19 outbreak where it noted that it will immediately postpone most foreign inspections until April 2020.  Additionally, the FDA canceled all foreign travel by agency officials and said it is limiting domestic travel to “mission critical only” through April.  Last month, FDA stopped conducting inspections in China.
  • In its update, FDA stated that when it is not temporarily able to physically inspect foreign produced FDA-regulated products or manufacturers, it will employ additional measures to ensure the safety of products imported to the U.S., which include denying entry of unsafe products into the country, physical examinations and/or product sampling at borders, reviewing a company’s previous compliance history, and using information sharing from foreign governments as part of mutual recognition and confidentiality agreements.
  • The FDA also noted that it will continue to partner with U.S. Customs and Border Protection to target products intended for importation into the U.S. that violate applicable legal requirements for FDA-regulated products, which may come from a variety of sources, such as first-time importers who may be unfamiliar with regulatory requirements or repeat offenders trying to circumvent the law.
  • FDA mentioned that it will continue to assess and calibrate its approach as needed to help advance federal response efforts in the fight against COVID-19.  We will continue to monitor any developments.
  • The FDA and FTC issued joint warning letters to seven companies for selling fraudulent COVID-19 (Novel Coronavirus Disease 2019) products. The warning letters were sent to Vital Silver, Quinessence Aromatherapy Ltd., Xephyr, LLC doing business as N-Ergetics, GuruNanda, LLC, Vivify Holistic Clinic, Herbal Amy LLC, and the Jim Bakker Show. The products cited in the warning letters range from teas, essential oils, tinctures, to colloidal silver.
  • The agencies asserted that the products pose significant health risks to patients and are unapproved drugs intended to mitigate, prevent, treat, cure, or diagnose COVID-19 in violation of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(a). The FDA and FTC requested the companies respond in 48 hours describing the specific steps they have taken to correct the violations. In addition to following up with companies that fail to make adequate corrections, the agencies will monitor social media, online marketplaces, and incoming complaints to ensure fraudulent products are not on the market.
  • In regard to the warning letters, FTC Chairman Joe Simons stated “[t]here already is a high level of anxiety over the potential spread of coronavirus. What we don’t need in this situation are companies preying on consumers by promoting products with fraudulent prevention and treatment claims. These warning letters are just the first step. We’re prepared to take enforcement actions against companies that continue to market this type of scam.”
  • In their press release, the FDA reminds consumers to be cautious of websites and stores selling products that claim to prevent, mitigate, treat, diagnose, or cure COVID-19. There are currently no vaccines or drugs approved to treat or prevent COVID-19. An FDA cross-agency task force has been established to closely monitor for fraudulent products related to COVID-19. The task force has been in contact with major retailers asking for help in monitoring online marketplaces for fraudulent products claiming to combat coronavirus. The task force has already worked with some major retailers to remove more than three dozen listings of fraudulent COVID-19 products.
  • In a March 9 email to stakeholders, Health Canada’s Food Directorate requested data in regard to food additives in certain food flavouring preparations. The Food Directorate is responsible for assessing health risks and benefits, setting standards, policies and regulations, and providing advice and information regarding the safety and nutritional quality of food. In Canada, all permitted food additives and their conditions of use are listed in the Lists of Permitted Food Additives (“Lists”). In its email, the Food Directorate stated that it intends to modify the Lists to specify which coloring agent(s), preservative(s) and emulsifying agent(s) are permitted in flavoring preparations and their maximum levels of use. The agency noted that this would be similar to the listing for the sweetener, thaumatin.
  • In its email, the Food Directorate stated that stakeholder data will ensure that food additives currently in use are considered when the agency modifies the Lists. The Food Directorate requested the following information:  (1) A list of the coloring agents, preservatives and emulsifying agents currently being used in flavoring preparations subject to the compositional standard for (naming the flavor) extract and (naming the flavor) essence or the compositional standard for (naming the flavor) flavor; (2) The purpose for which each food additive is used in the flavoring preparation (this should be explanatory in nature, not simply a reference to the functional class of the additive (g. “antimicrobial effect” for Class II preservative); and (3) The typical and maximum level of use of each food additive in each type of flavoring preparation, expressed as percent by weight if the use level is 1% or greater or parts per million if the use level is less than 1%.
  • The Food Directorate asks that interested stakeholders submit data by May 9, 2020. We will continue to monitor any developments and are happy to help submit data to Health Canada’s Food Directorate.
  • We have discussed a public hearing that FDA held on May 31, 2019 to obtain scientific data and safety information on the wide array of FDA-regulated products already on the market that contain cannabidiol (CBD).  This hearing was part of FDA’s effort to explore whether it would be possible to develop a regulatory pathway for CBD-containing foods and dietary supplements to be lawfully marketed.  Subsequently, FDA stepped up its CBD enforcement action last year against a wide array of CBD-containing products making disease and health-related claims, as we reported.  When Congress appropriated funds for hemp/CBD market surveillance activities in December 2019, it directed FDA to report on progress toward obtaining and analyzing data to help determine a policy of enforcement discretion and a process in which CBD will be evaluated for lawful use in FDA-regulated products.
  • FDA’s Report to Congress was publicly revealed on March 5, 2020 and indicated that little actual progress has been made.  The most significant development is that FDA is considering developing a risk-based enforcement policy that could possibly clarify FDA’s enforcement priorities.  Given the widespread availability of such products, however, an informal policy of enforcement discretion has been in place for some time.  Progress toward quickly providing for the lawful use of CBD in dietary supplements and conventional food is not likely, however, as 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.  To facilitate obtaining data that would make it possible to determine whether there may be any safe conditions of use for CBD in any FDA-regulated consumer products, aside from the one currently FDA-approved prescription drug use, FDA announced that it will reopen the docket that was created following the May 31, 2019 hearing and that it is working on a process whereby companies can provide proprietary information on specific products on a confidential basis.
  • FDA’s report was only slightly more hopeful about the prospect of future rulemaking or an enforcement policy on the use of CBD in dietary supplements, as compared to conventional foods, for which an eventual FDA clearance seems particularly challenging.  On the whole, the report emphasizes significant obstacles that include FDA’s ability to provide adequate regulatory oversight, workload considerations, and how to make consumers aware of limitations in FDA’s oversight of dietary supplements that may be particularly significant for CBD-containing products, as well as tangential safety concerns like heavy metal contaminants and other impurities or undeclared ingredients.  As to consumer awareness issues, the report also reiterates concerns about false marketing claims for CBD products, cumulative exposure, and use by vulnerable populations. An FDA Statement for the public was issued concurrently with the disclosure of the congressional report to educate consumers on the FDA status of CBD-containing products and warn of potential health risks.
  • Keller and Heckman advises clients regularly on the status of CBD in FDA-regulated products. We will continue to monitor FDA’s development of a potential regulatory framework and the direction of additional enforcement action to assess the risks and opportunities for companies marketing these types of products.

On March 4, 2020, the U.S. Food and Drug Administration (FDA), in collaboration with the U.S. Environmental Protection Agency (EPA) and the U.S. Department of Agriculture (USDA), launched a new initiative, “Feed Your Mind,” to help educate consumers about foods created through genetic engineering (commonly referred to as GMOs or genetically modified organisms).

The initiative addresses some of the most common questions consumers have about GMOs, including what GMOs are, how and why they are made, how they are regulated, and to address health and safety questions. The initiative will launch in phases, including a new website, fact sheets, infographics and videos. Additional materials, including resources for health professionals, a supplemental high school science curriculum, and consumer materials, are scheduled for release in 2020 and 2021.

In developing the initiative, FDA, EPA, and USDA formed a steering committee and working groups with agency leaders and subject matter experts; sought input from stakeholders in public meetings; opened a docket to receive public comments; reviewed scientific literature and research, and conducted formative research.

GMOs remain an area of potential controversy, both from a regulatory perspective and in litigation. Keller and Heckman attorneys continually monitor this area for regulatory developments, as well as consumer and competitor challenges. If you have any questions or need assistance in this area, please email: fooddrug@khlaw.com.

  • In a February 2020 letter, a group of 58 lawmakers urged FDA Commissioner Stephen Hahn to prohibit plant-based alternatives from labeling their products with traditional dairy terms.  The lawmakers noted that, unless FDA starts enforcing its existing standards of identity for milk and prohibit the use of terms, such as “milk” on plant-based products, the agency will only reinforce consumers’ misconceptions that plant-based milks provide the same nutritional content as animal-based milk.
  • In their letter, the lawmakers referenced recent opinions, which warned the public not to use plant-based substitutes in place of cow’s milks for young children.  For example, a report issued by the American Academy of Pediatrics, American Heart Association, Academy of Nutrition and Dietetics, and American Academy of Pediatric Dentistry urged parents to avoid feeding young children plant-based milk products, as they do not contain the same nutrients as cow’s milk.  In addition, USDA guidelines have noted that plant-based products sold as “milks” may be consumed as a source of calcium; however, USDA also stated that their overall nutritional content is not similar to dairy milk.
  • Many of the lawmakers who signed the letter to the FDA also support the Dairy Against Limitations and Replacements of Yogurt, Milk, and Cheese to Promote Regular Intake of Dairy Everyday Act (“DAIRY PRIDE Act”). The DAIRY PRIDE Act, introduced in March 2019, would designate foods that make an inaccurate claim about milk contents as “misbranded” and subject them to enforcement of labeling rules.  Moreover, the DAIRY PRIDE Act would require FDA to issue guidance for nationwide enforcement of mislabeled imitation dairy products within 90 days of its passage and would require FDA to report to Congress two years after enactment.  In late January, Tom Balmer, the Executive Vice President of the National Milk Producers Federation, testified before a congressional subcommittee on behalf of the bill.  We will continue to monitor any developments.
  • The coronavirus (COVID-19) is having global public health implications and its economic impact cannot be underestimated. The full extent will not be known until many months, or even years, down the road. On the regulatory side, we are often asked by companies who conduct business in China how this will impact the ability to seek new product clearances and whether pending dossiers will be delayed.
  • The virus hit China at a time when the country was celebrating the Chinese New Year, so most government agencies responsible for reviewing various food, drug and cosmetic dossiers were  closed for business.  Since that time, there have been over 80,000 cases in China, mostly in Wuhan, the capital city of Hubei Province.  In Shanghai, where Keller and Heckman has its Asian operations, the city has seen a total of 338 people diagnosed with the virus.
  • The applications for various products in China have been impacted by the outbreak, but the government is doing the best it can under the circumstances to bring things back to normal. Government employees in various agencies are reporting back to work, albeit on a limited and restricted basis.  By way of a few examples, the Center for Drug Evaluation (CDE) continues to process submissions of Drug Master Files (DMFs).  Applications for non-special purpose cosmetic products can be submitted to provincial-level market regulation agencies in person or preferably by mail.  For petitions handled by the National Health Commission (NHC) and Center for Food Safety and Risk Assessment (CFSA), including food additives, new food ingredients and food-related products, dossiers are accepted, but the corresponding expert panel review meetings may be delayed, given that “group gathering” events are not currently allowed in Beijing.
  • The team in Keller and Heckman’s Shanghai office has returned to work remotely since early February.  Thus, they are ready to serve our clients in matters related to China and APAC regions.  If you need their support, please do not hesitate to reach out to your ordinary contact at Keller and Heckman.
  • A proposed class of consumers is urging a Massachusetts federal judge not to dismiss its suit against a Florida CBD supplement manufacturer over the potency of its products. By way of background, in September 2019, plaintiff Marjorie Ahumada filed suit against Florida-based Global Widget LLC, owner of Hemp Bombs brand, claiming that its products do not contain the advertised dosages. Ahumada claimed to have purchased two packages of Hemp Bombs gummies for about $17 in Massachusetts. The packages were advertised as pure and “high potency,” and that the gummies contained 75 milligrams of CBD, which Ahumada understood to mean 15 milligrams per gummy. According to the plaintiff’s own testing, the gummies contained a much smaller amount of CBD, or even none at all.
  • In their January motion to dismiss, Global Widget argued that Ahumada’s allegations were futile and that the product testing was insufficient. “Despite such bold claims, the complaint fails to describe the alleged laboratory testing or its methodology or allege that the testing was performed on the actual purchased product.” Now Ahumada and the proposed class are asking that the suit not be dismissed, arguing that the testing the proposed class performed on the products is adequate at this point in the case. Ahumada stated that “[t]he [first amended complaint] sufficiently alleges the claims on the CBD products are false and misleading because the products contain less CBD than advertised as demonstrated by plaintiff’s testing.”
  • Additionally, in their motion to dismiss, Global Widget further argued that the court should stay the case pending forthcoming CBD regulations from the FDA. Ahumada, however, argued that any new rules or guidance from the FDA would be forward-looking only and would not impact the lawsuit.
  • The lawsuit is one of a growing number of private actions filed alleging false and misleading CBD product labeling. We will continue to monitor this case as well as other CBD-related lawsuits and regulatory actions.