• Fourteen senators, including Senate Minority Whip Dick Durbin (D-IL), have sent a letter to FDA criticizing the agency for what it characterizes as lax enforcement that has allowed children to get addicted to flavored vape products in recent years.  In particular, the letter calls out flavors like gummy bear, cotton candy, peanut butter cup, and cookies ‘n cream as examples of flavors that appeal to children.  The letter poses a number of pointed questions as to how FDA will seek to curb e-cigarette use in children moving forward and is particularly critical of FDA’s 2017 decision to delay its regulation of e-cigarette products and flavorings from 2018 to 2022.
  • The letter follows on the May 2018 joint warning letters that the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) sent to 13 companies marketing flavored nicotine-containing e-liquids that resembled foods appealing to children (e.g., juice boxes, candies, cookies).  In the letter, the senators describe this enforcement initiative as a “modest” step to address e-cigarette use in children.  The letter states “considerably more must be done to address this looming wave of youth tobacco addiction aided, in part, by FDA inaction.”
  • Meanwhile, FDA is in the process of determining whether and how to regulate flavored tobacco products, including e-liquids, pursuant to its authority under the Tobacco Control Act.  Earlier this year, FDA published an Advanced Notice of Proposed Rulemaking on the regulation of flavored tobacco products, comments for which were due by July 19, 2018.  Thousands of comments have been submitted, including many comments from adult consumers, as well as scientific evidence claiming that flavored e-liquids provide a public health benefit by making it easier for cigarette smokers to transition to vaping.
  • The senators close by stating that companies that wish to use flavors in their tobacco products “should be required to demonstrate…that use of flavors will benefit public health—today, not four years from now.”  The letter arguably puts pressure on FDA to take a tougher stance on enforcement against e-liquid companies and could prompt FDA to take additional enforcement against flavored e-liquid manufacturers.  For more on developments on e-liquids and related products, please visit our companion blog, the Continuum of Risk.
  • In an unusual move, FDA Commissioner Scott Gottlieb, M.D., released a statement on July 24 regarding the voluntary recall of certain products that contain whey powder that may be contaminated with Salmonella. FDA stated that they are working with Mondelēz International, Inc., Pepperidge Farm Inc. and Flowers Foods, Inc. to initiate voluntarily recalls of certain products, including varieties of Goldfish and Ritz crackers, several brands of swiss roll dessert products, and Hungry Man frozen microwaveable dinners. The Hungry Man products fall under the jurisdiction of USDA’s Food Safety and Inspection Service (FSIS) because they contain poultry, but the other voluntarily recalled products are within FDA’s jurisdiction.
  • It is currently not known how many food companies used the potentially contaminated whey powder, and there may be other recalls initiated in the coming days. However, federal officials have not received any reports of confirmed Salmonella illnesses related to the recalled foods. Commissioner Gottlieb made clear that these recalls are being initiated because of the potential risk and out of an abundance of caution, and that the FDA is actively engaged in the investigation.
  • When recalls involve food and food ingredients that are sold only on a business-to-business basis, the FDA has not historically revealed the companies involved, as such information is said to be protected as “confidential corporate information.” However, in the instant matter, both FDA and USDA named Associated Milk Producers Inc. (AMPI), a Minnesota-based milk company, as the ingredient supplier. Perhaps in an effort to mitigate the effects of the potential contamination, Commission Gottlieb stated that because the products are widely consumed, FDA is “taking steps to intervene early on this potential risk” and “will be communicating regularly with the public to provide information and updates on this issue.”
  • The Pennsylvania Supreme Court has upheld a tax on sugar-sweetened beverages approved by the Philadelphia city council in 2016 (see previous blogs here, here and here for background information on that tax and court challenges to the tax). Opponents of the tax had argued that the tax violated Pennsylvania’s Sterling Act of 1932, which prohibits cities from taxing items that are taxed by the state. In a 4-2 decision, the Supreme Court found that the city’s sweetened-beverage tax did not duplicate the state’s sales tax since the city’s tax is levied on distributors.
  • In its ruling, the Pennsylvania Supreme Court left open the possibility of defeating the tax through legislation (Philadelphia Magazine). The ruling stated, “The concern that unintended consequences may unfold are prevalent relative to the promulgation of experimental, remedial legislation such as the Sterling Act. Where the language of the governing statute is clear (or clear enough), however, the solution is legislative — and not judicial — adjustment. In this regard, this Court regularly alludes to the superior resources available to the General Assembly in assessing matters of social policy.”
  • A bill currently before the Pennsylvania legislature, HB 2241, would prohibit local jurisdictions from taxing food, beverages, and food and beverage containers. However, no action has been taken on the bill since it passed out of committee in May. Three states have passed similar bills. In October 2017, Michigan’s governor signed a bill prohibiting municipalities from levying local taxes on food and beverages. The following year, in March 2018, Arizona’s governor signed a bill prohibiting local jurisdictions from imposing taxes on soda or sugary drinks. Most recently, California’s governor signed a bill prohibiting local governments from imposing new taxes on groceries (see our July 2 blog).
  • We will continue to report on local jurisdictions’ efforts to bridge budget gaps and to fund various programs through sugar-sweetened beverage taxes, and on state bans of local taxes on food and/or sugar-sweetened beverages.

U.S. officials watching international outbreak; no illnesses reported here

107 countries received frozen vegetables recalled for Listeria

  • The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) confirmed Friday they are monitoring an outbreak of Listeria monocytogenes infections (listeriosis) linked to frozen vegetables produced and distributed from a facility in Hungary by Greenyard Frozen after nine people in Europe and one in Australia have died from infections by the outbreak strain.  Listeria monocytogenes IVb sequence type (ST) 6 that matches the outbreak strain from victims was isolated from frozen spinach and frozen green beans sampled at the facility.  It was also isolated in a sample from a floor drain at the packaging area confirming the environmental contamination of the Hungarian processing plant.
  • Food safety officials in Europe reported earlier last week that the implicated frozen vegetables had been distributed to at least 107 countries and territories, including the United States and Canada.  FDA has stated, however, that no current recalls in the United States are associated with the frozen vegetables produced and distributed by Greenyard Frozen.
  • Frozen spinach and frozen green beans may be eligible for an exemption from compliance with FDA’s Produce Safety Rule, which establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce.  Our detailed summary of the rule is available here.
  • In the 2018 POLITICO Pro Summit, FDA Commissioner Scott Gottlieb signaled that FDA will begin collecting comments regarding enforcement of standard of identity for “milk”.  As noted in our June 27 blog, FDA is holding a public meeting on July 26, 2018 to discuss its Nutrition Innovation Strategy, including standards of identity.  FDA indicated in April that it might solicit comments, Commissioner Gottlieb’s comments at the POLITICO Pro Summit appear to echo this sentiment.
  • Industry and certain lawmakers have taken issue with the use of the term “milk” by manufacturers of plant-based products, such as soy milk and almond milk, taking the position that it is a violation of the standard of identity.  Milk is defined as the “lacteal secretion . . . obtained by the complete milking of one or more healthy cows”, though FDA regulations also contemplate milk from other animals.  In his POLITICO Pro Summit speech, Dr. Gottlieb said “an almond doesn’t lactate,” implying that almond milk and other plant-based beverages, do not meet the standard of identity for milk.
  • Commissioner Gottlieb acknowledged that FDA has not been enforcing the standard of identity for milk as it pertains to plant-based beverages and that he cannot change FDA’s enforcement posture unilaterally.  He did commit, however, to developing a guidance document in about a year announcing FDA’s intent to enforce the standard of identity.
  • The Organization for Competitive Markets (OCM) and American Grassfed Association (AGA) have petitioned the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) to change its standard for making a “Product of the USA” claim on meat and meat products.
  • Currently, FSIS allows the statement “Product of USA” if either (1) the country to which the product is exported requires this phrase and the product is processed in the US or (2) the product “is processed in the US (i.e., is of domestic origin).”  This policy is articulated in USDA’s Food Standards and Labeling Policy Book.
  • The OCM/AGA petition seeks to change the FSIS “Product of the USA” standard to no longer state that the claim can be made if the product is merely processed in the US.  The new standard would require any “significant ingredients” (i.e., ingredients including meat, vegetables, fruits, dairy products, but excluding spices and flavorings) in the inspected product to be of domestic origin.  The proposed language is intended to stop the current practice of labeling foreign, imported meat and meat products as being “Product of the USA” simply by passing such products through a USDA-inspected plant, which OCM/AGA states is the current practice and is harming American farmers.  This is likely to be a compelling narrative for the Trump Administration and would make the FSIS standard more aligned with the Federal Trade Commission’s standard on “Made in the USA” claims.
  • On Monday, July 16, a California appeals court reversed a decision that would have required food manufacturers to label cereal products with cancer warnings, as per Proposition 65. As we have previously written on this blog, Proposition 65 is a right-to-know law that requires businesses to provide warnings when they knowingly cause exposures to chemicals that the state has listed as causing cancer or reproductive harm. However, the statute does not require cancer warnings when exposure to listed chemicals does not cause a significant cancer risk.
  • Plaintiff Richard Sowinski filed the suit to require Prop 65 acrylamide warnings on 59 cereals sold by three companies, Post Foods, LLC, General Mills, Inc., and Kellogg USA (the “Petitioners”). Cereal, like many roasted or fried foods, contains acrylamide. Although acrylamide was listed under Prop 65 in 1990, the actual danger of the chemical to humans is still poorly understood.
  • In June 2017, the trial court had denied the Petitioners motion for summary judgment.  In their appeal of that trial court decision, Petitioners argued that such warnings on cereals are preempted by federal law because “they would pose an obstacle to federal policy objectives to increase Americans’ consumption of whole grains.” In support, Petitioners cite to numerous federal statutes establishing that policy, and FDA letters to California regulators cautioning against Prop 65 warnings on cereals.  In one letter to California, FDA argued “that premature labeling of many foods with warnings about dangerous levels of acrylamide would confuse and could potentially mislead consumers, both because the labeling would be so broad as to be meaningless and because the risk of consumption of acrylamide in food is not yet clear.” In response to FDA’s letter, California’s Office of Environmental Health Hazard Assessment (OEHHA), the agency responsible for Prop 65 labeling, agreed to postpone requiring acrylamide warnings while FDA continued to study the chemical.  The California appeals court agreed with Petitioners’ preemption claims stating that the trial court had overlooked the FDA’s concern, thereby reversing the trial court ruling in favor of Plaintiff Sowinski and granting the Petitioners motion for summary judgment.
  • This decision is a huge win for the cereal industry and should be closely watched to see how it will impact other Prop 65 warning for acrylamide and potentially other chemicals of concern where a Prop 65 warning could chill consumption of healthy foods.
  • The U.S filed five separate trade cases at the World Trade Organization (WTO) challenging tariffs, many on agriculture products, imposed in response to tariffs announced by President Trump on aluminum and steel. The five countries are China, the European Union, Canada, Mexico, and Turkey. With respect to tariff imposed by China, we previously reported on this blog that the U.S agricultural industry is concerned about potential financial losses due to these tariffs.
  • U.S. Trade Representative Robert Lighthizer said in a press release that the U.S. imposed tariffs were legitimate and justified but that our trading partners responded with retaliatory tariffs rather than working with us to address a common problem. He added, “These tariffs appear to breach each WTO Member’s commitments under the WTO Agreement.  The United States will take all necessary actions to protect our interests, and we urge our trading partners to work constructively with us on the problems created by massive and persistent excess capacity in the steel and aluminum sectors.”

 FDA warns of imposters sending consumers fake warning letters – Scammers are targeting consumers who have purchased medicines online (July 13, 2018 FDA news release)

  • The U.S. Food and Drug Administration is warning consumers about criminals forging FDA warning letters to target individuals who tried to purchase medicines online or over the phone.  Instead of receiving the medicines they paid for, consumers have received fake warning letters, generally addressed to a “Sir/Ma’am.”  The letters allege the order has been intercepted and threaten that “we are still investigating the root of this delivery & necessary legal steps will be taken if we found [sic] out any suspicious activity on your end.”
  • In reality, FDA does not typically take action against individuals purchasing a medicine online.  FDA typically sends warning letters directly to companies and individuals involved in the manufacturing or distribution of FDA-regulated products.  It would be highly unusual for FDA to send any official communication to an individual consumer.
  • FDA cautions of the risks of purchasing medicines from illegal online pharmacies.  Dangers include receiving counterfeit medicines or being the victim of scams such as the current one.  FDA advises that medicine can be purchased online safety by buying only from U.S.-licensed pharmacies that require a prescription.
  • The Food, Drug, and Cosmetic Act (FDCA) Section 403(q)(5)(H) (located at 21 USC Section 343(q)(5)(H)) requires certain vending machine operators to provide calorie declarations for certain foods sold in their vending machines.  FDA has previously issued a rule implementing this statutory provision – vending machine operators have until July 26, 2018 to provide the calorie disclosure and they may do so using a Front of Pack (FOP) disclosure using letter size that is at least 50% of the largest printed matter on the label.
  • On July 12, 2018, FDA proposed a revision to the rule.  In response to concerns expressed by industry, FDA is considering revising the minimum size requirements for the FOP calorie declaration to 150% of the size of the Net Quantity of Contents Declaration.  Other possible revisions considered were to not require a specific size for the declaration or calorie declaration equal to at least 100% of the Net Quantity of Contents Declaration.
  • FDA also announced that it is extending enforcement discretion regarding type size for the FOP calorie declaration until the rulemaking is complete.  FDA will also push off enforcement of calorie declaration for gum, mints, and roll candy products in packages too small for FOP labeling until at least January 1, 2020 while it considers this issue further.
  • FDA is accepting comments on the proposed rule until September 25, 2018.