FDA Commissioner Scott Gottlieb Resigns

  • On Tuesday, March 5, FDA Commissioner Scott Gottlieb announced he would resign at the end of the month. Gottlieb, a physician and former deputy commissioner in the George W. Bush administration, was confirmed as FDA Commissioner in May 2017. The resignation was not sought by the White House, as confirmed by a senior White House official. Rather Gottlieb, who commutes weekly to Washington from Connecticut, said he wants to spend more time with his family. In a letter to FDA staff, Gottlieb noted “[t]here’s perhaps nothing that could pull me away from this role other than the challenge of being apart from my family these past two years and missing my wife and three young children.”
  • Unlike some former commissioners, during his tenure, Gottlieb focused much of his time on issues related to food and tobacco. For example, as part of its 2018 Strategic Policy Roadmap, FDA signaled its intent to modernize certain standards of identity (SOI) to address current barriers to the development of healthier products while making sure consumers have accurate information about the foods they eat.  Relatedly, under Gottlieb’s direction, FDA requested comments on the use dairy terms in the labeling of plant-based products. See our previous posts on SOI modernization and the plant-based products labeling debate. As for food safety, examples of FDA action include plans to modernize oversight of imported food and the investigation of several product recalls, including the November 2018 romaine lettuce E. coli outbreak. And in April 2018, FDA issued its first ever mandatory recall. Additionally, Commissioner Gottlieb dedicated his efforts to reducing tobacco-related disease and death and curtailing youth access to tobacco products and e-cigarettes. Tobacco- and e-cigarette-related posts can be found here.
  • Prior to his departure, Commissioner Gottlieb vowed to continue to work to cement more of FDA’s pending efforts, to secure the 2020 budget, and to help transition the agency to new leadership. At this time, Commissioner Gottlieb’s replacement has not been announced.

FDA Takes New Steps to Curtail Youth Access to Tobacco Products and E-Cigarettes

  • The U.S. Food and Drug Administration (FDA) announced several new steps it is taking to combat youth access to tobacco products and e-cigarettes. In a March 4 statement, FDA Commissioner Scott Gottlieb, M.D., pointed out that retailers are on the frontlines of these efforts to reduce the health consequences of tobacco use and nicotine dependence and outlined the actions that the Agency is taking, beginning with ones directed at retailers.
  • First, FDA sent a letter to Walgreen Co.’s corporate management requesting a meeting to discuss the company’s policy on selling tobacco products to kids. Walgreens is currently the top violator among pharmacies that sell tobacco products, with 22% of the more than 6,350 stores inspected by FDA having illegally sold tobacco products to minors. (See our Feb. 8, 2019 blog for more information on previous action that FDA took against retailers, including Walgreens, selling tobacco products to minors.)
  • Second, FDA plans to also hold accountable 15 other national, corporate-owned chains and franchise stores with high rates of violations for illegal sales of tobacco products to minors. The agency will request information on what policies they have in place and what more they can commit to do to prevent youth tobacco sales. “Companies should be on notice that the FDA is considering additional enforcement avenues to address high rates of violations,” stated Dr. Gottlieb said in the statement, adding “Ignoring the law and then paying associated fines and penalties should not simply be viewed as a cost of doing business.”
  • With respect to retailers, Dr. Gottlieb added that FDA will continue to utilize its voluntary national retailer education program called “This is Our Watch,” which includes free resources designed to support retailers’ efforts to educate their staff on enforcing federal laws and regulations.
  • Third, on March 4, FDA sent its first warning letters to several companies for, among other things, selling electronic nicotine delivery system (ENDS) products and a waterpipe tobacco product with labeling and/or advertising that failed to include the required nicotine warning statement.
  • Fourth, FDA sent letters, also on March 4, to a number of governors across the country thanking them for their work to support efforts that led to the more than 81,570 warning letters that the Agency sent to retailers for violating the law, as well as the issuance of more than 19,800 civil money penalties and about 145 no-tobacco-sale orders for repeated violations since FDA began conducting tobacco retailer inspections in 2010.
  • Dr. Gottlieb concluded by stating, “We’ll continue vigorous enforcement activities, with a sustained campaign to monitor, penalize and help prevent e-cigarette sales to minors in retail locations, including manufacturers’ internet storefronts, as well as take additional steps to tackle other concerns related to the youth access and appeal of these products.” He added that FDA is also exploring additional enforcement avenues to target violative sales and marketing practices by manufacturers and retailers.

Putative Class Action Filed Against Walmart, Costco, Amazon and Others Alleging Coffee is Falsely Labeled as “Kona”

Amazon, Walmart, Costco Sued Over Fake ‘Kona’ Coffee (subscription to Law360 required)

  • Section 43(a) of the Lanham Act (15 U.S.C. 1125) permits a civil action for, among other reasons, “false designation of origin.”  To prevail, a plaintiff must prove the designation of origin is false, that it is used in a commercial advertisement (e.g., a label) in interstate commerce, that it deceives or is likely to deceive in a material way, and it has caused or is likely to cause competitive or commercial injury to the plaintiff.
  • A group comprising all of the coffee farmers in the Kona District of the Big Island of Hawaii filed a class action on February 27, 2019 in the U.S. District Court for the Western District of Washington against the producers and sellers of 19 brands of coffee that are identified as “Kona” but allegedly contain no Kona coffee or only trace amounts.  Defendants include sellers such as Walmart, Costco, Amazon, Safeway, Kroger, Cost Plus/World Market, and Bed Bath & Beyond as well as several producers based in Hawaii and in the mainland.  The plaintiffs point out that only 2.7 million pounds of coffee are grown in the Kona region each year, but more than 20 million pounds of coffee are labeled with the name and they offer a report on analytical testing of trace metals in the allegedly counterfeit coffee to prove that it was not produced in the Kona region (which is said to yield coffee with a distinct flavor profile that commands premium prices).
  • A Hawaiian newspaper reports that the attorneys representing the Kona coffee growers in the Lanham Act lawsuit also plan to file another class-action lawsuit based on the same claims on behalf of consumers who bought allegedly fraudulent Kona coffee.
  • The designation of origin for Kona coffee can be distinguished from the use of common cheese names which, as reported here, have been the subject of longstanding trade disputes between the United States and the European Union.  Whereas “Kona” is clearly used to indicate coffee grown in the Kona region of Hawaii, parmesan and other some other names are used generically to indicate a specific style of cheese and are not necessarily geographical indicators that imply the cheese is produced in a certain place, such as Parma, Italy.

 

 

This Week’s Cannabis Highlights

  • As previously reported in this blog, the 2018 Farm Bill removed hemp – defined as Cannabis sativa L. with less than 0.3% THC on a dry weight basis – from the definition of “marihuana”.  The 2018 Farm Bill also assigned responsibility for regulating the manufacture of hemp to the states under plans approved by USDA or by USDA itself.  As reported on the Marijuana Moment website here, on Wednesday, in a hearing regarding The State of The Rural Economy with the House Agriculture Committee, Sonny Purdue, Secretary of USDA, announced that he thinks the USDA rules will be in place in late 2019 – in time for the 2020 growing season.  He noted that regulation will be further complicated by hemp’s “relationship to other crops that [USDA is] not encouraging.”  On February 27, USDA announced a webinar regarding hemp.
  • We have also reported on FDA’s continuing opposition to the inclusion of cannabis extracts in food or dietary supplements.  As widely reported, included by CNBC in a February 28 hearing with the House Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, Committee on Appropriations, FDA Commissioner Scott Gottlieb announced he is putting together a working group to develop rules that would permit the use of certain extracts from hemp in food or dietary supplements.  According to Commissioner Gottlieb, FDA is planning a public hearing in April.
  • In tech news, researchers in California have developed modified yeast with genes that create enzymes that essentially brew cannabinoids, including THC and CBD.  Not only could such a method reduce the environmental burden of producing cannabinoids, it would also permit manufacturers to manufacture cannabinoids of extremely high purity for use in pharmaceuticals.  See the engadget, Wired, and Nature articles for more information.

EFSA Report Indicates Antimicrobial Resistance in EU Is Increasing

  • The European Food Safety Authority (EFSA) and the European Center for Disease Prevention and Control (ECDPC) have issued a joint summary report on antimicrobial resistance in the EU based on data from its 28 Member States.
  • The 278-page report summarizes findings that antimicrobial resistance is increasing in bacteria that cause disease when transmitted from animals to humans (i.e., zoonotic diseases)—such as Campylobacter, Salmonella, and E. coli.  EFSA found that in some countries resistance of Campylobacter to ciprofloxacin and erythromycin, for example, is so high that there are few antibiotics left to treat severe infections in humans.  Further, methicillin-resistant Staphylococcus aureus (MRSA) was detected in pigs, calves, and hens, as well as meat from these food-producing animals.
  • As previously reported on this blog, antibiotic resistance continues to be of high concern for food safety authorities (including FDA), non-profit organizations, and corporations.

National Milk Producers Federation Petitions FDA on Non-Dairy Alternative Labels

  • As previously reported on this blog, FDA’s comment period on the use of the terms, such as milk, yogurt, and cheese, in the labeling of plant-based products ended on January 28, 2019. FDA’s standard of identity for milk defines milk in part as the “lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows.
  • On February 21, 2019, after the end of FDA’s comment period, the National Milk Producers Federation filed a citizen petition to FDA requesting that the agency: (1) enforce existing “imitation” labeling requirements against non-dairy substitutes for dairy foods; and (2) codify FDA policies to permit the name of a standardized dairy food to be used in the statement of identity of a non-dairy substitute for standardized food when products are deemed nutritionally equivalent to the dairy products they reference.
  • Pursuant to 21 CFR 10.30(e)(2), the FDA must respond to citizen petitions within 180 days of receipt although the response may not be substantive and could simply be that they need more time to review the citizen petition.  FDA action or response to its request for comments on labeling of plant-based products is also forthcoming.  We will continue to monitor this situation and report on any developments.

FDA’s Outlines Plans to Modernize Oversight of Imported Food

  • The U.S. Food and Drug Administration (FDA) discusses how the Agency is integrating new tools, that are a result of the passage of the Food Safety Modernization Act (FSMA),  with existing ones to improve the safety of imported foods in a newly released publication, “Strategy for the Safety of Imported Food.” (For background information on these new tools, see our previous blogs on the Foreign Supplier Verification Program (FSVP), the Accredited Third-Party Certification program’ and the Voluntary Qualified Importer Program (VQIP).)
  • Noting that the U.S. imports about 15% of its overall food supply from more than 200 countries or territories, FDA explained that the volume and variety of imported food and the complexity of global supply chains make food safety a challenging issue to address. Below is a brief summary of the goals that FDA has outlined in the Strategy document.
  • Goal 1 – Food Offered for Import Meets U.S. Food Safety Requirements. This involves optimizing the use of foreign inspection, effective implementation of the FSVP, use of reliable third-party audits and the VQIP. In addition, FDA will collaborate with foreign governments, standards development organizations, and others. For example, FDA has made system recognition arrangements with New Zealand, Canada, and Australia and is working with the European Union on a mutual assessment.
  • Goal 2 – FDA Border Surveillance Prevents Entry of Unsafe Foods. FDA’s surveillance of imported food at more than 300 active U.S. ports of entry generally involves screening, examination, sampling, and testing. The Agency plans on incorporating new sources of information into import screening and expanding testing methods. Additionally, FDA will collaborate with state and other regulatory authorities; use import alerts; and require import certification as a condition of admission, where appropriate.
  • Goal 3 – Rapid and Effective Response to Unsafe Imported Food. While FSMA granted FDA mandatory recall authority, voluntary recalls are still the primary means to remove “violative products” from the U.S. food supply. Reaching this goal will also involve gaining greater access to information from foreign sources and maximizing effectiveness of response to an event involving imported food. FDA also plans to further develop and refine processes to enable use of Agency authorities to prevent importation of unsafe food from facilities, including those with suspended registrations.
  • Goal 4 – Effective and Efficient Food Import Program. FDA will develop an improved global inventory of food facilities and farms to optimize resource allocation for imported food safety oversight to areas of higher risk.
  • In a statement on FDA’s new strategy to advance oversight of imported food, FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas concluded, “Overall, our modern strategy is designed to leverage our different authorities and tools to provide a multi-layered, data-driven, smarter approach to imported food safety.”

Enforcement Activity by the USDA Food Safety Inspection Service Against Imported Siluriformes (Catfish) for “Failure to Present” Violations

 

  • As reported here, the domestic and import inspection program for Siluriformes fish and fish products (including catfish) was transferred from FDA to USDA in response to a congressional mandate.  After September 1, 2017, only foreign countries that had submitted documentation showing the equivalence of their Siluriformes fish inspection system with that of the U.S. could continue exporting these products to the U.S.  Additionally, as of August 2, 2017, all shipments of imported Siluriformes entering the U.S. must be presented at an Official Import Inspection Establishment for re-inspection by USDA Food Safety and Inspection Service (FSIS) personnel.
  • FSIS routinely monitors distributors and cold storage facilities for “failure to present violations.”  Recent recalls suggest that enforcing the re-inspection requirement of the Siluriformes fish inspection system is an important priority for FSIS.  See Fulton Seafood (February 22, 2019), TV Food (February 22, 2019), Richwell Group (February 5, 2019), American Best (February 4, 2019), H&T Seafood (January 18, 2019) and Mannarich Food (December 15, 2018).
  • The recall classification for products that are violative on account of not being presented for FSIS re-inspection as required is Class I ( i.e., “involves a health hazard situation in which there is a reasonable probability that eating the food will cause health problems or death”).  Further, FSIS routinely issues health alerts for such products although they have not typically been associated with other actionable defects or reports of adverse reactions due to consumption.

 

Washington Bill Would Make Food and Other Brand Owners Responsible for Plastic Waste

  • House Bill 1204 and Senate Bill 5397 would prohibit producers that do not participate in a plastic packaging stewardship organization from selling packaging made wholly or in part from plastic in Washington State, beginning in 2022. Plastic food service products, including utensils, and other specified plastic items associated with food or beverage service are included in the definition of plastic packaging. A “producer of plastic packaging” is defined as a person that meets one of these criteria:
  1. Has legal ownership of the brand to which plastic packaging is applied;
  2. Is the first importer into Washington state of a product to which plastic packaging is applied;
  3. Sells at retail a product, to which plastic packaging has been applied; or
  4. Otherwise elects to assume compliance responsibility for a product.
  • The legislation specifies that the stewardship organization must submit a plan to the Washington State Department of Ecology and that plan must be approved by the department. The legislation provides details on what must be included in the plan, such as a description of the plastic packaging categories covered by the program, an analysis of plastic packaging litter found in public places, a funding mechanism for the program, and a description for plastic packaging collection. With respect to food packaging, a comprehensive analysis of the overall amount of packaging in the recycling waste stream containing more than de minimis food residue or food waste is required.
  • The Washington Senate Environment, Energy and Technology Committee has passed the senate version of the bill and it is now before the Senate Ways & Means Committee, which has scheduled a hearing on the bill for February 25. The House Bill is before the Committee on Environment and Energy. Plastics Recycling Update points out that while extended producer responsibility (EPR) programs for packaging have not been implemented in any U.S. state, they have taken effect throughout Canada and in parts of Europe.

Dog Food Makers Face Multiple Class Action Lawsuits Following Vitamin D Recalls

  • Following on recalls of dog food due to excess Vitamin D in late 2018, manufacturers are facing lawsuits by dog owners claiming their pets were injured by the products in question.
  • According to FDA, analysis of the recalled dog foods by state and private labs indicate that the dog food contained as much as 70 times the intended amount of vitamin D, and all eight brands that were subject to the recall had been produced by the same contract manufacturer.
  • In one class action suit, filed against Hill’s Pet Nutrition in the Eastern District of New York, plaintiffs are claiming that the company delayed warning consumers.  Specifically, the suit claims that consumer complaints started in February 2018, 11 months prior to the company recalling its products in late January 2019.  Similar suits have been filed in Florida and California, and there may be more to come.
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