FDA Publishes Findings from Investigation of Romaine Lettuce E. coli Outbreak

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  • As previously reported on this blog, in November 2018 FDA, in conjunction with the CDC, state officials, and Canadian food and public health officials, investigated an outbreak of E. coli O157:H7 infections in multiple US states and Canadian provinces. The investigation determined the cause of the outbreak was the consumption of contaminated romaine lettuce. Indeed, thirty (83%) of 36 ill consumers interviewed reported eating romaine lettuce the week before illness onset. All E. coli O157:H7 isolates from ill consumers had a rare genetic fingerprint, as determined by whole genome sequencing (WGS), that was closely related to one previously seen in ill consumers in the fall of 2016 and the fall of 2017. The November 2018 outbreak was declared over in the US on January 9, 2019.
  • On February 13, 2019, FDA released the findings from the Agency’s investigation of the November 2018 outbreak. With the help of WGS, investigators were able to narrow down the growing location of the romaine lettuce to specific California counties. The traceback investigation further identified multiple farms that may have been the cause of the outbreak.
  • In their report, FDA identified factors that most likely contributed to the contamination of romaine lettuce, specifically from one farm in Santa Maria in Santa Barbara County, California. Those factors include the following:
    • The outbreak strain of E. coli O157:H7 was found in the sediment of an on-farm water reservoir in Santa Maria.
    • The outbreak strain was not found anywhere else in sampling done during the investigation in various California leafy greens growing areas and counties.
    • The water from the on-farm water reservoir most likely led to contamination of some of the romaine lettuce. The water was likely not effectively sanitized. The water may have come in contact with the romaine through multiple avenues, including direct harvest/postharvest application and/or use of water on harvest equipment.
    • FDA is not sure how the water became contaminated.
    • Other ranches owned by the same farm, as well as other farms, may have sold contaminated lettuce.
    • Due to the fact that the same specific strain of E. coli O157:H7 occurred in 2016 and 2017, it may be likely that the strain remained in the environment or repeatedly introduced from an unknown source.
  • Based on these findings, FDA provided recommendations for the prevention of future outbreaks. Such recommendations include adhering to the recommendations of the Environmental Assessment associated with the spring 2018 STEC outbreak, FSMAs Produce Safety Rule, and FSMAs Preventive Controls for Human Foods Rule. And specifically for growers of leafy greens, FDA recommends assessing the growing operations, assuring all agricultural water is safe and of adequate sanitary quality, and performing a root cause analysis when a foodborne pathogen is identified.
  • The findings provide hope that growers and public health officials will be able to prevent or mitigate potential future outbreaks.

The full FDA report can be accessed here.

FDA Takes Action on Dietary Supplements Claiming to Treat Alzheimer’s Disease and Other Serious Conditions

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  • FDA has issued warning letters and online advisories to a number of dietary supplement companies whose products claim to prevent, treat, or cure Alzheimer’s disease and other serious conditions.  The disease claims cause the supplements to be considered unapproved new drugs that violate the Federal Food, Drug, and Cosmetic Act.
  • The products in question include tablets, capsules, and oils containing ingredients such as avocado oil, green tea extract, omega-3 fatty acids, black cumin seed oil, and coconut oil.  In addition to making Alzheimer’s disease claims, the products also claim to treat conditions such as the flu, high blood pressure, parasites, asthma, and diabetes.
  • In a related press release, FDA noted that these products pose a risk to the public because they “may be ineffective, unsafe and could prevent a person from seeking an appropriate diagnosis and treatment.”  Given that FDA Commissioner Scott Gottlieb has launched an initiative to improve the safety of dietary supplements, including more rapidly communicating with the public about potential safety issues, we can expect to see more of these press releases and enforcement actions in the future.

New York Judge Lifts 2-Year Stay on KIND “All Natural” Suit (subscription to Law360 required)

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  • A New York federal court ordered a consumer class action against KIND LLC to move forward after a two-year stay. Consumers are suing KIND for allegedly mislabeling its snack products as both “non-GMO” and “all natural,” even though the products purportedly contain synthetic and genetically modified ingredients.  On September 15, 2016, U.S. District Judge William H. Pauley III stayed the “all natural” claims pending possible new FDA guidelines on use of the term.  At the time of the stay, the court stated that it would “reconsider the appropriateness of continuing the stay as the FDA’s process unfolds.” The “non-GMO” claims were stayed in 2018 to avoid splitting the two issues apart.
  • As a reminder, in November 2015, the FDA published a Request for Information and Comments regarding the use of the term “natural” in the labeling of food products, including foods that are genetically engineered or contain ingredients produced with genetic engineering. See 80 FR 69905 (Nov. 15, 2015). Although the comment period closed in May 2016, FDA has not taken any further action on this matter.
  • In 2018, Judge Pauley denied both KIND’s motion to dismiss and the consumers’ request to lift the stay on their “all natural” claims. The stay was to be in effect, and subsequently reconsidered, until August 15, 2018. However, six months have now passed since the court deadline, and thus Judge Pauley decided to lift the stay. Judge Pauley stated that there is “no indication whether the FDA is earnestly working toward a uniform ‘natural’ standard, or whether it has shelved that effort. […] As such, this court explained that it ‘cannot sit idly by on an illusory assurance that something is likely to happen.’”
  • As we’ve previously posted on this blog, “natural” and “all natural” lawsuits have been the focus of much litigation in recent years. And as this court order indicates, such suits do not appear to be slowing down.

FDA to Strengthen Dietary Supplements Regulation

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  • On February 11, FDA Commissioner Scott Gottlieb, M.D. announced a new plan for modernizing and strengthening dietary supplement regulation and oversight. In making the announcement, Dr. Gottlieb pointed out that supplement use is increasing with three out of every four American consumers taking a dietary supplement on a regular basis. Also, since Congress passed the Dietary Supplement Health and Education Act (DSHEA) 25 years ago, the dietary supplement market has grown significantly—from a $4 billion industry to an industry worth more than $40 billion.
  • “As the popularity of supplements has grown, so have the number of entities marketing potentially dangerous products or making unproven or misleading claims about the health benefits they may deliver,” Dr. Gottlieb explained, adding that the new plan has the goal of implementing one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years.  Under the plan, FDA will implement the five steps described below.
  1. Develop new ways to communicate more quickly when FDA is concerned that an ingredient is unlawful and potentially dangerous and should not be marketed in dietary supplements. This will involve a new rapid-response tool.
  2. Ensure that the regulatory framework for dietary supplements is flexible enough to adequately evaluate product safety while promoting innovation. The guidance that FDA is developing for preparing new dietary ingredient (NDI) notifications is part of this effort. “An effective NDI notification process represents the FDA’s only opportunity to evaluate the safety of a new ingredient before it becomes available to consumers and helps promote transparency and risk-based allocation of resources,” Gottlieb explained. (See our blog on FDA’s NDI Draft Guidance for background information.)
  3. Undertake more collaborative research with industry, such as the recently created the Botanical Safety Consortium, a public-private partnership to promote scientific advances in evaluating the safety of botanical ingredients and mixtures in dietary supplements. This group will look at novel ways to use cutting-edge toxicology tools, including alternatives to animal testing.
  4. Continue to take actions to protect public health and develop new enforcement strategies. (On February 11, FDA sent 12 warning letters and five online advisory letters to companies  whose products, many of which are marketed as dietary supplements, are being illegally marketed as unapproved new drugs.)
  5. Establish public dialog on whether additional steps are necessary to modernize DSHEA. These steps could include amending the statute to establish avenues for dietary supplement exclusivity and a mandatory listing requirement to improve transparency, possibly help facilitate efficient enforcement of the law, and establish new mechanisms to identify bad actors.
  • In the coming months, FDA will provide addition details on steps it is taking to modernized dietary supplement regulation, Dr. Gottlieb added.

Finalized Guidance for Industry and FDA Staff on Public Warning and Notification of Firm-Initiated or FDA-Requested Recalls

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  • As covered on this blog, FDA has worked to strengthen the recall process for food, drugs, medical devices, and cosmetics in response to a report by the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services concluded that FDA’s recall process can be too slow and puts consumers at risk.  21 CFR Part 7, Subpart C provides guidance on policy, procedures, and industry responsibilities for recalls (including product corrections).
  • Final guidance issued February 7, 2019 further outlines the circumstances when a company should issue a public warning about a voluntary recall (i.e., where there is a serious health risk and other means for preventing the use of a recalled product appear inadequate), describes the general timeframe for companies to issue such a warning (i.e., generally within 24 hours of notification that FDA believes a public warning is appropriate), discusses what information should be included in a public warning (including how to identify the recalled product and characterize the reason for the recall), and describes situations where FDA may issue its own public warning if a company’s warning is deemed insufficient.  The final guidance also describes FDA’s policy for moving forward with posting recalls to FDA’s Enforcement Report, which is a web listing of all recalls monitored by the FDA (including recalls that do not present serious hazards to health).  A recall may sometimes be posted to FDA’s Enforcement Report website before a final health hazard evaluation is completed.
  • FDA Commissioner Dr. Scott Gottlieb announced the final guidance on public warning and notification of recalls in a press release and also touted FDA’s other recent measures to protect consumers from health risks related to recalled products.  Such measures include draft guidance that describes situations where FDA will disclose retail information for recalled food products and mandatory recall guidance for foods, which was finalized in November 2018 and answers common questions about the mandatory food recall provisions.
  • Dr. Gottlieb further remarked on FDA’s implementation of the public warning and notification guidance last year while it was still in draft form, suggesting that FDA’s more prominent publicizing of recalls through social media and other routes may have given the impression that the number of recalls has increased when, in fact, the number of recalls in fiscal year 2018 (i.e., 7,420 recalls; 831 of which were classified as the highest risk) represents a five-year low.

 

FDA Takes Action Against Retailers Selling Tobacco Products to Minors

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  • On February 7 FDA initiated enforcement action against a Miami, Florida Walgreens and a Charleston, South Carolina Circle K store for repeated sales of tobacco products to minors.  The enforcement action, called a no-tobacco-sale-order (NTSO) would prevent the individual stores from selling any tobacco product for thirty days.
  • In its press release, FDA noted that Walgreens is the top violator amongst pharmacies that sell tobacco products, having been cited for tobacco sales to minors during 22 percent of the retail compliance check inspections at Walgreens stores since they began in 2010.  These violations have resulted in over 1,550 warning letters and 240 civil money penalties, but this is  the first NTSO at a Walgreens store.  Other stores identified as frequent violators include Walmart (17.5 percent of inspections resulted in sales to minors violations), Dollar General (14 percent), and Rite Aid (9.6 percent).
  • FDA commissioner Dr. Scott Gottlieb is quoted in the press release as being “deeply disturbed” by the number and frequency of sales to minors at Walgreens stores and he called on Walgreens management to meet with him to discuss why so many Walgreens stores fail to prevent sales to minors.  Dr. Gottlieb speculated that the pharmacy setting might impact consumer perceptions regarding the safety of tobacco products.
  • We will continue to track the ongoing regulation of tobacco products.  For more, check out The Continuum of Risk Blog.

Proposed EU Hygiene Rules for Insects Used in Food

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  • Novel Food Regulation (EU) 2015/2283 describes the authorization process for novel food products in the European Union (EU). “Novel food” is defined as food that had not been consumed to a significant degree by humans in the EU before May 15, 1997. “Novel Food” can be newly developed, innovative food, food produced using new technologies and production processes, as well as food which is or has been traditionally eaten outside of the EU. We previously reported on the associated guidance documents for the Novel Food Regulation published by the European Food Safety Authority (EFSA) here and most recently analyzed the legal status of insects in Europe in our Tomorrow’s Food and Feed blog.
  • As a subset of “novel food,” dead insects, parts of them and processed insects are subject to authorization under the Novel Food Regulation. The European Commission (EC) reports that insects intended for human consumption are increasingly produced in or exported to the EU as they are used as an alternative to mainstream food of animal origin. As such, the EC has proposed to add a section to the existing regulation outlining the hygiene rules for food of animal origin, Regulation (EC) No 853/2004, to include rules specifically for insects for human consumption.
  • If implemented, minimum hygiene requirements for the production of insects to protect against contaminants would need to be followed to place insects for human consumption on the market in the EU. The draft regulation is open for public comment until February 20, 2019. We will continue to monitor regulatory developments for the authorization of novel foods, both in the US and abroad.

New York City, Ohio, and Maine Crackdown on Food Products with CBD

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  • City and state officials in New York, Ohio, and Maine have placed embargoes on food products containing cannabidiol (CBD).  The embargoes, which appear to have all begun in January, require restaurants and retailers to remove all CBD-containing food products from their shelves and prohibit their sale.  In all three jurisdictions, however, restaurants and retailers were allowed to keep the embargoed items.
  • New York City’s Department of Health and Mental Hygiene (DOH) said in a statement that eateries within its jurisdiction were not “permitted to add anything to food or drink that is not approved as safe to eat. […] The Health Department takes seriously its responsibility to protect New Yorkers’ health. Until cannabidiol (CBD) is deemed safe as a food additive, the Department is ordering restaurants not to offer products containing CBD.” DOH is following FDA’s position on the use of cannabis or cannabis-derived compounds in food and dietary supplements. In sum, per FDA, it is illegal to sell a food or dietary supplement that contains added CBD in interstate commerce. Further information about FDA’s position can be found here.
  • In Ohio, officials hold that the embargo is an enforcement of the state law establishing Ohio’s medical marijuana program, which strictly prohibits CBD sales outside of the state’s 56 licensed dispensaries. The Ohio Board of Pharmacy reminded retailers of this restriction in an advisory issued in the fall of 2018.
  • Similarly in Maine, the state has ordered all stores that sell edible CBD products to remove them from their shelves. Such a move has caused much confusion among retailers and consumers, as the products have reportedly been sold across the state for over two years. In response, State Representative Craig Hickman introduced a bill to clarify that the production and sale of CBD in food products would be allowed under Maine law.
  • With the passage of the 2018 Farm Bill, public interest in CBD and related products continues to grow. Indeed, as previously reported on this blog, several senators are now asking FDA to update “outdated” federal regulation governing the use of certain hemp-derived ingredients in food, beverages, and dietary supplements. We will continue to monitor any updates related to this broad issue.

More States Attempt to Ban Sodas from Kids’ Meals

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  • Recently introduced Kids’ Meal Bills in Connecticut and Rhode Island would prohibit restaurants from including soft drink beverages on children’s menus and in children’s meals. More specifically, Connecticut House Bill 7006 would limit beverages listed on children’s menus to “water, sparkling water, flavored water with no added sweeteners, unflavored milk or a nondairy milk alternative,” effective January 1, 2020. It was referred to the Joint Committee on Children on January 31, 2019, and is one of the agenda items to be considered at the Committee’s Public Hearing this Thursday.
  • Connecticut’s bill defines “Nondairy milk alternative” as “a fluid milk substitute that meets the standards established pursuant to the National School Lunch Program meal requirements for lunches and requirements for afterschool snacks.” By way of background, flavored, low-fat milk was temporarily added to the milk option in the National School Lunch Program in November 2017 and on December 12, 2018, USDA published a final rule in the Federal Register to codified that change, effective February 11, 2019 (see 86 FR 63776).
  • Rhode Island’s Health Beverage Act, 2019 – S 0179, was introduced on January 24, 2019, and referred to the State’s Senate Special Legislation and Veterans Affairs Committee. It specifies that default beverages in children’s meals must be one of the following:
    • Water, sparkling water, or flavored water, with no added natural or artificial sweeteners;
    • Nonfat or 1% milk or non-dairy milk alternative containing no more than 130 calories per container and/or serving; or
    • 100% fruit juice or fruit juice combined with water or carbonated water, with no added sweeteners.
  • While several states introduced similar legislation last year, California was the only state to pass a Kids’ Meal Bill (see our August 29, 2019 blog for details). However, efforts to eliminate sweetened soft drinks from children’s menus are continuing into the current legislative session.

Court Rules En Banc for Injunction Against San Francisco’s Health Warning Requirement for Soft Drink Ads

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  • As previously covered on this blog, the City of San Francisco passed legislation in June 2015 that required health warnings to be placed on advertising for sugar-sweetened beverages (i.e., nonalcoholic beverages with caloric sweeteners that contain more than 25 calories per 12 oz.). Specifically, the warning would have read: “WARNING: Drinking beverages with added sugar(s) contributes to obesity, diabetes, and tooth decay. This is a message from the City and County of San Francisco.” Additionally, the law required that the warning occupy 20% of the ad space and be outlined with a rectangular border. On September 19, 2017, the 9th U.S. Circuit Court of Appeals in American Beverage Assn. v. San Francisco enjoined enforcement of the ordinance, reversing the district court and holding that requiring advertisers to include the controversial warning violates their First Amendment rights not to be compelled to convey the government’s message.
  • In a January 31, 2019 opinion, the full court agreed that the trade association plaintiffs would likely succeed on the merits of their claim that San Francisco’s warning requirement is unconstitutional and that preliminary injunction factors also weighed in the plaintiffs’ favor. Recognizing that the government may compel speech that is purely factual, noncontroversial, and not unjustified or unduly burdensome, the en banc court found that the size requirement for the mandatory warning in San Francisco’s ordinance was not justified and would likely chill protected commercial speech. The court did not reach the issues of whether the warning statements is factual and not controversial.
  • While San Francisco’s current law will not take effect, the court left open the possibility that a smaller size requirement (such as 10%) may not be unduly burdensome. Thus, it is possible that San Francisco or another U.S. jurisdiction may craft future legislation for a warning requirement on sugary beverages that will pass the constitutional test for not unduly chilling protected commercial speech.

 

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