• As previously covered on this blog, Philadelphia enacted a 1.5-cent-per-ounce tax on distributors of sweetened beverages (including soda and diet soda, non-100% fruit drinks; sports drinks; flavored water; energy drinks; pre-sweetened coffee or tea; and non-alcoholic beverages intended to be mixed into alcoholic drinks) as a revenue generating measure to fund local health and education needs. The tax took effect on January 1, 2017, but has faced legal challenges, most notably by the American Beverage Association (ABA) (see previous blog coverage here).
  • On May 1, 2018, a Pennsylvania legislative committee signed off on a measure that would invalidate the tax on sweetened beverages and preempt other municipalities in the state from enacting similar measures. The bill, which was approved by the Pennsylvania House Commerce Committee on a 17-9 vote, would prevent local governments from placing fees, surcharges, or taxes on food, beverages, and food and beverage containers.
  • Alex Baloga, head of the Pennsylvania Food Merchants Association, hailed the bill, saying it will “protect all Pennsylvanians from new taxes on food and beverages, including hardworking families who can’t afford more expensive grocery bills, small businesses that would lose customers and labor groups whose members could see their jobs cut.” However, this bill is just one aspect of the fight over the sweetened beverage tax. Currently, the Pennsylvania Supreme Court is weighing whether the tax is an improper duplication of the state’s sales tax. And Pennsylvania Governor Tom Wolf has already vetoed one bill passed by the General Assembly that would prevent municipalities from enacting taxes on food and beverage containers, like plastic bags.
  • Sweetened beverage taxes are relatively new initiatives, with Berkeley, California passing the first beverage tax in November 2014. And although it is well established that excess sugar consumption is inadvisable, it remains to be seen whether such taxes will be able to strike a balance between public health and consumer choice.
  • The Missouri House approved a bill that would ban companies from labeling lab-grown meat products or meat substitutes as meat (St. Louis Post Dispatch). The labeling proposal is included in House Committee Bill 16, which passed the House by a vote of 107 to 38 on April 26, 2018. Now before the state Senate, the legislation has a May 18 deadline to reach the governor’s desk to be signed. The bill is supported by the Missouri Farm Bureau, the Missouri Cattlemen’s Association, and the state’s pork producers, while companies that produce plant-based, meat-like products oppose the legislation.
  • If this bill is signed into law, Missouri would be the first state to address this issue. However, on the national level, as previously reported on this blog, the United States Cattlemen’s Association  filed a petition with the USDA’s Food Safety and Inspection Service (FSIS) requesting that the Agency undertake rulemaking on beef labeling to clarify for consumers the difference between beef derived from cattle and “beef” products created in a laboratory.
  • The popularity of plant-based meats is increasing. For example, we reported in September 2017, that retail sales of plant-based foods intended to replace animal products rose by 8.1 percent over the previous year, topping $3.1 billion in sales. As this trend continues, we expect to see more regulatory activity in this area and will continue to report on future developments.

 

  • As previously reported on this blog, opposing sides have urged the Food and Drug Administration (FDA) to weigh in on the use of the term “milk” in labeling plant-based products, such as “soy milk” and “almond milk.”
  • The dairy industry asserts that plant-based products labeled using milk or other dairy-related terms violate FDA’s standard of identity regulations, and has urged FDA to take action.  In January 2017, Senator Tammy Baldwin (D-WI) introduced a bill, the Dairy Pride Act, which would have amended the Federal Food, Drug, and Cosmetic Act to prohibit the sale of any food that uses the market name of a dairy product, and is not the milk (i.e., lacteal secretion) of a hooved animal, is not derived from such milk, or does not contain such milk as a primary ingredient.
  • On the other side of the debate, the Good Food Institute (GFI) petitioned FDA in March 2017 for a regulation to clarify that “new foods may be named by reference to other ‘traditional’ foods in a manner that makes clear to consumers their distinct origins or properties.”  GFI’s request states that a significant and growing group of consumers has sought to reduce or eliminate dairy products from their diet and that plant-based alternatives to traditional dairy products are becoming more common.  FDA responded within the 180-day timeframe (required by law), but only to indicate no action was being taken at the time and suggesting the issue was not a high priority for future activity.
  • Last week, however, there was some indication that FDA may finally prioritize the issue.  Addressing questions from Senator Baldwin at an April 25, 2018 Senate Appropriations Committee Hearing, FDA Commissioner Gottlieb promised forthcoming FDA activity, but not imminent enforcement against “almond milk” or other such products.  Specifically, Dr. Gottlieb indicated that with industries’ reliance on FDA’s “regulatory discretion” on use of the term “milk” on plant-based products, data on consumer understanding are necessary before FDA could act.  In this regard, the commissioner indicated that FDA will issue a request for information on consumer understanding of the terms at issue and any potential confusion over nutritional equivalency.  While this process is not likely to be completed quickly, it may eventually bring some greater certainty to the labeling of these types of products.

 

  • As reported previously in the Daily Intake Blog, labeling of foods as “Healthy” has recently elicited strong and varied opinions.  KIND filed a Citizen Petition in December 2015 requesting that the Food and Drug Administration (FDA) revisit the definition of “healthy” to take into account present-day scientific understanding about the health benefits of many nutrient-dense foods.  FDA issued a request for comments on the subject in September 2016; see the Daily Intake Blog post here.
  • In a Citizen Petition dated April 19, 2018, Pete and Gerry’s Organics LLC (Pete and Gerry’s) filed a petition requesting that FDA update the regulation for the term “healthy” to allow eggs to bear the claim “healthy” and apply enforcement discretion allowing eggs to be labeled as healthy until the regulation is updated.  Pete and Gerry’s argues that current dietary guidance emphasizes healthy dietary patterns, including consumption of eggs as a nutrient-dense food; the consumption of dietary cholesterol is no longer capped in U.S. dietary guidance, and the current evidence suggests that eating eggs may be part of a healthy diet, so elevated cholesterol content should not preclude eggs from being considered healthy; and FDA’s policy is outdated and not in line with modern science.
  • Consumer class action lawsuits have targeted healthy claims.  Without clarification from FDA, some argue that healthy claims will continue to promote old, and possibly outdated, eating habits.  Keller and Heckman will continue to monitor evolving developments relating to health and nutrient content claims.
  • A California Court of Appeals has rejected various arguments made by Monsanto Company, challenging the listing of glyphosate based on the Proposition 65 Labor Code listing mechanism, where carcinogens listed by the International Agency for Research on Cancer are automatically listed under Proposition 65.
  • The court did not agree that the Labor Code listing of IARC carcinogens amounted to an unconstitutional delegation of “a quasi-legislative authority to an outside agency without providing for adequate standards or appropriate safeguards.”  The court noted that Californians voted to pass Proposition 65 in part because they felt that state agencies had failed to adequately protect individuals from chemical exposures and decided that—at a minimum—some substances would be listed based on the Labor Code listing mechanism as a matter of course.
  • This decision adds to the caselaw concerning glyphosate under Proposition 65.  It remains to be seen where the dust will settle with regard to Proposition 65 warnings for glyphosate, which is now the subject of a 1,100 microgram safe harbor level, given the outcome of a recent decision in which a California federal court agreed that such warnings would be misleading commercial speech under the First Amendment of the Constitution.
  • The Centers for Disease Control and Prevention (CDC) found that romaine lettuce from the Yuma, Arizona growing region could be contaminated with E. coli O157:H7.  Thus far, 53 people infected with the outbreak strain of E. coli O157:H7 have been reported from 16 states. Thirty-one people have been hospitalized, including 5 people who have developed a type of kidney failure called hemolytic uremic syndrome. No deaths have been reported.
  • On April 20, the CDC expanded its warning to consumers to cover all types of romaine lettuce from the Yuma growing region. The warning now includes whole heads and hearts of romaine lettuce, in addition to chopped romaine and salads and salad mixes containing romaine.  Because package labels do not often identify growing regions, the CDC recommends consumers throw out any romaine lettuce, even if partially eaten, and avoid eating romaine lettuce at restaurants.
  • The contaminated growing region was identified after state and local health officials in Alaska interviewed sick inmates at a correctional facility to ask about the foods they ate and other exposures before they became ill. Traceback investigations show that the lettuce ill people ate came from whole heads of romaine lettuce from Yuma. However, at this time, no common grower, supplier, distributor, or brand has been identified. A lack of traceability coding has been blamed for the failure in identifying the source of the romaine. Traceability labeling and coding would allow finished product sent to retailers and foodservice operations to be traced back through the supply chain virtually immediately.
  • While the Food Safety Modernization Act (FSMA) Produce Safety Rule established specific recordkeeping requirements, traceability coding is not a requirement. Despite the lack of a federal requirement, it is possible food producers, specifically those who grow fresh fruits and vegetables, may begin to utilize traceability software to minimize the spread of outbreaks. Keller and Heckman will continue to monitor the multistate outbreak linked to romaine lettuce.

The California Office of Environmental Health Hazard Assessment (OEHHA) has proposed to amend the California Proposition 65 Clear and Reasonable Warnings requirements to provide an exception to the safe harbor provisions for listed chemicals in pesticides regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

  • As we previously reported on this blog, OEHHA published a final rule concerning “clear and reasonable warnings” required under Proposition 65 in September 2016. The new regulations, which become effective on August 30, 2018, provide guidance on the manner and content for providing warnings. Proposition 65 requires companies to provide warning statements where their products cause an “exposure” to listed chemicals. The warning requirements do not apply when an exposure falls within the “safe harbor.”
  • By way of background, most pesticides sold or distributed in the United States must be registered by the Environmental Protection Agency (EPA) under FIFRA. As part of the review and approval process, EPA evaluates each pesticide label. All label language must be approved by EPA before a pesticide can be marketed in the United States. Each pesticide label must use the signal word reflecting the Toxicity Category that the product is assigned by EPA. The signal words used under FIFRA include: “Danger,” “Warning,” and “Caution.” In addition, pesticides sold in California must be registered by the California Department of Pesticide Regulation (DPR), which has its own statutory and regulatory requirements for pesticide product labeling.
  • OEHHA proposed to allow the use of an alternate signal word in the “narrow circumstance” where the EPA and DPR signal word and the Proposition 65 signal word conflict. More specifically, a new subsection (d) would be added to the consumer product exposure warning content set forth in Section 25603. The alternate signal words, “ATTENTION” or “NOTICE,” in capital letters and bold print would be allowed instead of the word “WARNING” when the pesticide label is regulated by EPA pursuant to FIFRA and DPR and its implementing regulations. This exception would only apply when EPA or DPR require the use of a signal word other than “WARNING.” Comments on the proposal must be submitted to OEHHA by June 11, 2018. Information on how to submit comments can be found on OEHHA’s website.
  • Keller and Heckman LLP attorneys actively advise clients on compliance issues and enforcement actions related to California’s Proposition 65. If you have any questions about the implications of the Clear and Reasonable Warning requirements or other related issues, please email prop65@khlaw.com.

Bai Fruit Drinks Sued Over ‘All-Natural’ Labeling (subscription to Law360 required)

  • A national putative class action lawsuit (with proposed in-state subclass) was filed in California federal court on April 19, 2018 against Bai Brands, LLC alleging violation of California’s Consumers Legal Remedies Act, Unfair Competition Law, and common law, as well as the U.S. Food and Drug Administration’s (FDA) regulations.  The plaintiff alleges that Bai Brands falsely advertised fruit drinks as ‘natural’ and did not disclose malic acid, alleged to be a synthetic flavor used to mimic fresh fruit, on front of package labeling.  (Branca v. Bai Brands, LLC, 3:18-cv-00757).
  • Natural lawsuits continue to proliferate despite court ordered stays being granted in several challenges due to pending FDA action.  As previously covered on this blog, FDA is considering whether to regulate the term “natural,” having collected 7,687 comments in 2016 on use of the term ‘natural’ on human food labeling.
  • Commissioner Scott Gottlieb acknowledged the lack of clarity on the meaning of ‘natural’  in March 29, 2018 remarks at the National Food Policy Conference in Washington, DC and said FDA “will have more to say on the issue soon.”  It remains to be seen how long courts will continue to wait for FDA to act.

 

  • As first reported by the New York Times, and later confirmed under questioning by Rep. Doggett in a House Ways and Means Committee hearing, one plank of the United State’s platform in the renegotiation of the North America Free Trade Agreement (NAFTA) is the limitation on member countries from requiring front of pack labeling on foods that would indicate using symbols, like a stoplight, which foods are more or less healthy.
  • In a report, IEG Policy News noted that certain industry groups oppose mandatory front of pack labeling using such symbols because they oversimplify the information.  For example, the International Dairy Food Association notes that dairy products are nutrient rich and their consumption should be encouraged even though they may be considered high in calories or fat under some front of pack labeling regimes.  Industry groups are largely in favor of the voluntary Facts Up Front initiative, which does not include symbols to demarcate healthy or unhealthy choices.  Consumer advocacy groups, like Center for Science in the Public Interest, oppose restrictions on countries’ ability to impose mandatory warnings.
  • As we have seen in the battle over determining what foods are healthy, there are many ways that labeling could help promote or restrict the consumption of foods that generally promote a healthy lifestyle.  Determining which foods are healthy represents a policy choice that has yet to be made.  The fight over front of pack labeling appears to fall into the same rubric.  Keller and Heckman will continue to monitor and report.
  • In response to the U.S. Food and Drug Administration’s (FDA’s) 2016 Arsenic in Rice and Rice Products Risk Assessment Report, the Government Accountability Office (GAO) released a report on April 16, 2018 acknowledging the U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) efforts to develop methods to detect arsenic in rice but concluding that FDA could improve risk communications to the public, as well as coordination with other agencies to address arsenic in rice.
  • GAO recommends that FDA develop a timeline for updating its risk assessment and finalizing its draft guidance and that FDA and USDA develop a coordination mechanism for developing methods to detect foodborne contaminants, including arsenic.
  • Dr. Susan Mayne, Director of FDA’s Center for Food Safety and Applied Nutrition, released a statement on April 17, 2018 in which she concurs with the GAO recommendations and notes that the agency is seeking to establish an action level for inorganic arsenic in infant rice cereal by the end of 2018.