• 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  Such measures include draft guidance that describes situations where FDA will disclose retail information for recalled food products and mandatory recall guidance for foods, which was finalized in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.

 

  • 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.
  • 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.
  • 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.
  • 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.

 

  • 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.

 

A look at some recent news that we are following:

  • There has been a lot of action in state legislatures towards legalization of cannabis for medical use, recreational use, or both.  A recent Boston Globe article addresses the ten states where legalization is most likely this year. New York state appears to have had a setback in getting the legislation to legalize recreational use passed,  though the delay appears to be based on the difficulty in ironing out all the details before a budget is due rather than an outright unwillingness on the part of the legislature to legalize marijuana for recreational use.
  • The ban on smoking cannabis in Florida’s medical cannabis law was defeated in a trial court and is under appeal by the state.  However, the new governor, Ron DeSantis, has said he will drop the appeal and has given the legislature until mid-March to revise the statue accordingly. Governor DeSantis has also signaled an interest in relaxing the caps on numbers of permits and required vertical integration for the production and sale of medical marijuana, though he does not appear as focused on this as on the smoking ban.  In addition, Florida’s agriculture commissioner, Nikki Fried, has created a Director of Cannabis position to oversee the medical cannabis program.
  • William Barr, the nominee for the next Attorney General, has put in writing the pledge made during confirmation hearings to “not go after” companies growing or manufacturing marijuana in compliance with state laws and the Cole Memorandum (a memo issued by former Attorney General Cole and revoked by Attorney General Sessions that directed federal prosecutors to not prosecute for marijuana related crimes if a person was in compliance with state law and certain other Department of Justice priorities, like preventing revenue from the sale of marijuana from going to criminal enterprises, gangs, or cartels were not triggered). Mr. Barr has not committed to reinstating the Cole Memorandum, but marijuana advocates are heartened by his stance and willingness to commit his position to writing.  For more, see the Forbes article or many others published on the topic.

We will continue to monitor these and other news items related to cannabis.

  • The Minnesota Department of Agriculture (MDA) has issued a recall notice for three lots of raw turkey pet food manufactured by Woody’s Pet Food Deli after linking a human case of Salmonella Reading infection to the product.
  • The infected person served the recalled food to a pet, which also tested positive for Salmonella but a strain other than Salmonella Reading.  This is the second time MDA has issued a recall relating to a human Salmonella Reading infection from raw turkey pet food; the first was a year ago in February 2018, when two children in the Twin Cities metro area were infected—one of whom was hospitalized.
  • The Woody’s Pet Food is the latest of many raw turkey products that have been implicated in the human Salmonella Reading outbreak that has been ongoing since November 2017.  Since we last reported on the outbreak in November 2018, the rate of new illnesses has increased, with more than 50 new cases occurring in the past two months, bringing the total to 216 cases.
  • In a report released on January 30, the American Lung Association’s 2019 “State of Tobacco Control” finds that in 2018, states and the federal government failed to take meaningful action in putting in place policies to prevent and reduce tobacco use. The Association gave the federal government an “F” grade saying that it has failed to implement the Tobacco Control Act of 2009, and, on the whole, many states received poor grades in multiple categories, including funding for tobacco prevention programs, strength of workplace laws, level of tobacco taxes, coverage and access to services to quit tobacco, and minim age of sale for tobacco products.
  • In November 2018, FDA announced new steps to protect youth from flavored e-cigarettes, which would include sales restrictions for flavored e-cigarettes (except mint, menthol, and tobacco flavors) and soon-to-be-announced heightened age-verification for online sales of flavored e-cigarettes. FDA followed up on that announcement with a public hearing on January 18, 2019 focused on the role drug therapies could play in eliminating youth e-cigarette use. See FDA Holds Public Hearing on Strategies to Address Youth E-Cigarette Use for a more detailed analysis of the hearing.
  • However, the report specifically cites the surge of e-cigarette use among adolescents as “one clear consequence of FDA’s inaction” and that it believes FDA’s announced steps to restrict access to flavored e-cigarettes are insufficient. The Association proposes that the agency extend sales restrictions to mint and menthol flavors, and ultimately, prohibit all e-cigarettes. Whether the agency will take more actions on e-cigarettes is yet to be seen. Check Keller and Heckman’s Tobacco and E-Vapor blog, www.thecontinuumofrisk.com for more analysis of the regulation of tobacco and e-vapor products, including updates on contemplated sales bans on cartridge-based products and flavors.
  • As previously reported in September on this blog, FDA requested comments on the use of dairy terms—such as milk, yogurt, and cheese—in the labeling of plant-based products. FDA’s Standards of Identity define milk in part as the “lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows.” The original deadline for comments was November 27. However, on October 21, 2018, FDA announced that the comment period would be extended by 60-days to January 28, 2019. (See 83 Fed. Reg. 58775.)
  • FDA received 13,077 comments on the use of dairy terms in the labeling of plant-based products by yesterday’s deadline. While most of the comments are from individual consumers, industry and nongovernment organizations also weighed in with diverse opinions. The dairy industry urged FDA to enforce the Standard of Identity for milk. Some are the comments expressing this view are summarized below.
    • The Ohio Dairy Producers Association’s comments, submitted on November 14, state that it “opposes allowing imitation dairy products, such as those made from soy, almond or other non-dairy ingredients, to bear the names of traditional or standardized dairy foods.”
    • The National Milk Producers Federation (NMPF) posted comments that it submitted on January 28 on its website. In a news release about the comments, NMPF stated, “The U.S. Food and Drug Administration must enforce its existing rules against mislabeling plant-based products with dairy terms to address widespread consumer confusion over the nutritional content of dairy-product imitators.” The NMPF commissioned a poll that found 49% of those questioned believe that non-dairy brands should not be allowed to use the term “milk” on their product labels because they are often less nutritious than dairy milk. Also, 61% of those polled said that they believe the FDA should restrict non-dairy beverage companies from using the term “milk,” while 23% believe that FDA should not restrict non-dairy beverage companies. The poll was conducted by Ipsos on January 4-7, 2019, and involved online interviews of 1,005.
    • James O’Reilly, professor of public health systems and director of the Concentration in Health Services Management at the College of Medicine of the University of Cincinnati, also submitted comments. Noting that he has taught food and drug law for 30 years and has no financial interest in a milk products company or alternative “milk” marketer, he stated, “Until and unless Congress changes the statute, FDA should enforce it. FDA should recognize that standards of identity have a long standing special position within the food safety and food marketing regulatory environment.”
  • Opposing opinions were expressed by organizations representing plant-based dairy producers and many of the individual commenters. Some of these comments are summarized below.
    • The Good Food Institute (GFI) stated in comments submitted on January 28, “FDA should not restrict plant-based dairy producers from using conventional dairy terms on their labels. However, if the agency were to depart from longstanding practice and create new rules that substantially affect how plant-based dairy producers conduct their business, it must promulgate a new regulation through notice-and comment rulemaking.” To support this view, GFI cited the fact that FDA has for several decades allowed products to be labeled using qualified standardized terms, such as “gluten-free bread” even through it doesn’t meet the standard of identity for bread. GFI also pointed out that 37% of all U.S. households purchase plant-based milk and that the plant-based milk category now stands at $1.8 billion annually. It concluded by stating, “Without a showing that consumers are actually confused by the labels of plant-based dairy products, and that there is no less restrictive means possible of ensuring clarity other than prohibiting plant-based dairy producers from using conventional dairy terms on their labels, FDA has no authority to act.”
    • The Vegetarian Resource Group (VRG), stated in its comments, “We believe that prohibiting plant-food labels from including words like milk, cheese, and yogurt in the name of these products would lead to consumer confusion. We urge you to permit the labeling of plant-based products with names that include milk, cheese, and yogurt.”