• The effectiveness of taxing sugar-sweetened beverages to reduce the amount of sugar consumed has been the subject of debate for several years. As we’ve previously reported on this blog, the World Health Organization (WHO) issued a report in 2016 that concluded that taxing sugary drinks (and foods) reduces their consumption. However, an independent panel advising WHO did not recommend taxing sugary drinks in the 2018 report, “A Time to Deliver” (see our June 5, 2018 blog).
  • The most recent endorsement for taxing sugary beverages as a method to reduce the consumption of sugar is by the American Academy of Pediatrics and the American Heart Association. These groups issued a Policy Statement with six recommendations to reduce sugary drink consumption in children and adolescents. The first recommendation is:
    • “Local, state, and/or national policies intended to reduce consumption of added sugars should include the consideration of approaches that increase the price of sugary drinks, such as an excise tax. Such taxes should be accompanied by education of all stakeholders on the rationale and benefits of the tax before implementation. Tax revenues should be allocated, at least in part, to reducing health and socioeconomic disparities.”
  • Studies on the effectiveness of sugar-sweetened beverage taxes have not given consistent results. For example, the Philadelphia Inquirer summarized five studies on the impact of Philadelphia’s soda tax (more about the tax can be found here and here). Conclusions varied—depending on the study—from decreased consumption of sweetened beverages to no significant decrease in sugar intake due to the tax. As a result, the Philadelphia City Council approved a resolution last week to conduct another study on the effect of the city’s sweeten beverage tax. The new study will evaluate whether the tax hurts local businesses. Prior to approving the new study, the Philadelphia City Council introduced a bill that could significantly amend the city’s soda tax law or possibly eliminate it (Philadelphia Inquirer). Hearings on the bill will not be held until the study is completed.
  • We will continue to report on efforts to tax sugary beverages and other foods, efforts to repeal these taxes, and the effectiveness of the taxes.
  • As previously reported on this blog, on March 5, FDA Commissioner Scott Gottlieb announced plans to resign from his post as FDA Commissioner beginning in April. Gottlieb was confirmed as FDA Commissioner in May 2017 and drove several significant initiatives from food safety modernization to youth nicotine use.
  • On March 12, 2019, Alex M. Azar III, Secretary of Health and Human Services announced that Dr. Ned Sharpless would serve as acting FDA Commissioner when Scott Gottlieb steps down in April. The appointment is temporary as the administration searches for a permanent replacement to Gottlieb. Since October 2017, Sharpless has served as director of the National Cancer Institute. He is also the chief of the aging biology and cancer section in the National Institute on Aging’s Laboratory of Genetics and Genomics. “Dr. Sharpless’s deep scientific background and expertise will make him a strong leader for F.D.A.,” said Mr. Azar, in a statement.
  • Mr. Azar noted, “[t]here will be no let up in the agency’s focus, from ongoing efforts on drug approvals and combating the opioid crisis to modernizing food safety and addressing the rapid rise in youth use of e-cigarettes.” However, with Gottlieb’s departure, it remains to be seen whether the agency will continue Gottlieb’s efforts in the area of food and tobacco, including reevaluating certain standards of identity, modernizing the oversight of imported food and product recalls, and curbing youth e-cigarette use.

 

 

  • Drs. Susan Mayne, head of the Food and Drug Administration’s (FDA’s) Center for Food Safety and Applied Nutrition (CFSAN), and Dennis Keefe (head of CFSAN’s Office of Food Additive Safety) published a post on the FDA Voices blog on March 21 discussing FDA’s  Voluntary Plant Biotechnology Consultation Program (the Consultation Program) and the Plant and Animal Biotechnology Action Plan.
  • Under the Consultation Program, which has been in existence since 1995 and has conducted 184 consultations, companies are encouraged to provide FDA with information on the biotechnology so that FDA can provide individualized guidance on the data needed to address potential issues arising out of the biotechnology.  The company then presents the data to FDA and they work together to address any residual issues.  At the conclusion of the review, FDA provides the company a letter and posts relevant information about the review on its website.  More details on the Consultation Program can be found in FDA’s Statement of Policy.
  • On October 30, 2018, FDA announced its new Plant and Animal Biotechnology Innovation Action Plan.  As outlined in the Daily Intake Blog at the time, “the priorities are intended to ensure the safety of plant and animal biotechnology products, foster continued public confidence in FDA’s regulation of these products, and avoid unnecessary barriers to future innovation consistent with FDA’s mission to protect and promote the public health”.   See our blog post or FDA’s landing page for more.
  • On March 21, FDA’s Center for Veterinary Medicine (CVM) announced a webinar on the topic of “Genome Editing in Animals” scheduled for April 25. This webinar, originally scheduled for December 3, and long linked to the Plant and Animal Biotechnology Innovation Action Plan, “will be focused on information for those using genome editing to develop animals with genomic alterations. In the future, CVM intends to provide opportunities for other stakeholders, such as animal producers and farmers, who may be interested in raising genome-edited animals”.  The webinar is open to the public, but advance registration is required.
  • The San Francisco City Attorney, in coordination with the City’s Board of Supervisors, announced on March 20, 2019 that it will introduce legislation to prohibit the sale and delivery of e-cigarettes in the City unless such products have been established as “appropriate for the protection of the public health” through the Food and Drug Administration (FDA) Premarket Tobacco Product Application (PMTA) process.  Notably, the City Attorney did not indicate any intention to prohibit the sale of cigarettes within the City, the most addictive and deadly tobacco product.
  • To date, no e-cigarettes have received PMTA authorization from FDA. However, e-cigarettes that were on the market on August 8, 2016, the date FDA’s “Deeming Rule” went into effect, are permitted to remain on the market pursuant to FDA’s recently revised compliance policy.  Once the compliance policy is finalized, flavored e-cigarettes (other than tobacco, mint and menthol flavors) will have until August 8, 2021 to submit PMTAs, unless they are being marketed in a way that poses greater risk of minor access.
  • The City Attorney, along with attorneys for New York City and Chicago, also sent a letter to departing FDA Commissioner Dr. Scott Gottlieb criticizing the Agency for failing to curb the crisis of youth e-cigarette use.  In a press conference announcing the proposed legislation and the joint letter to FDA, the San Francisco City Attorney cited recent statistics on the rise of youth tobacco use and stated, “The FDA has simply failed to do its job in unprecedented fashion.”
  • San Francisco is the home of e-cigarette giant Juul Labs.  According to the City Attorney’s office, the legislation–which is not yet public–would prevent Juul from expanding on City property if it engaged in the sale, manufacture and distribution of tobacco products.  For more details on this and other tobacco-related news, please see our Continuum of Risk Blog
  • As previously reported on this blog, there has been considerable discussion around the regulation of cell-cultured meat both at the federal and state levels. Earlier this month, USDA and FDA published a formal agreement regarding federal agency oversight of human food produced using cell technology. Under the formal agreement, FDA will oversee cell collection and the development/maintenance of cell banks up and until the harvesting stage, where regulatory oversight will then transfer to USDA, which will conduct inspections of establishments where cultured cells are harvested, processed, packaged, and labeled, in accordance with FSIS regulations.
  • However, there have been parallel discussions at the state level, with a focus on the labeling of cell cultured products. For example, an Arizona state lawmaker recently introduced a bill that, if enacted, would make it illegal to label a product as “meat” if it is “not derived from harvested production livestock.” The same restrictions would apply to labeling a product as “chicken,” if it was not once live poultry. The bill, HB2604, was introduced to the Arizona House Committee on Land and Agriculture by David Cook (R-Globe), with specific intention to prevent cell-cultured meat from being labeled “meat.” However, HB2604 was not met without criticism. For instance, some lawmakers questioned whether the bill could withstand a federal preemption legal challenge. And while the bill failed to pass the House, it is up for reconsideration within the month.
  • As our readers are aware, Arizona is not the only state stepping into the discussion. Missouri, Nebraska, South Dakota, North Dakota, and several other states have introduced legislation that would prohibit representing a product as meat that is not derived from livestock or poultry. And as interest in cell-cultured meat continues to grow, more states are likely to enter the debate. We will continue to monitor and report on regulatory activity in this area.
  • As previously reported on this blog, U.S. Senator Tammy Baldwin’s (D-WI) introduction of the Dairy Pride Act  in 2017 was met with controversy. On March 14, 2019, Sen. Baldwin, along with Sens. Jim Risch (R-ID) and Mike Crapo (R-ID), reintroduced The Defending Against Imitations and Replacements of Yogurt, milk, and cheese to Promote Regular Intake of Dairy Everyday Act (DAIRY PRIDE Act). The legislation is cosponsored by Sens. Patrick Leahy (D-VT), Debbie Stabenow (D-MI), and Angus King (I-ME), and has been introduced in the House by Representatives Peter Welch (D-VT) and Mike Simpson (R-ID).
  • The DAIRY PRIDE Act would prohibit non-dairy products made from nuts, seeds, plants, and algae from being labeled with dairy terms like milk, yogurt, and cheese. It also would require the U.S. Food and Drug Administration (FDA) to issue guidance for nationwide enforcement of mislabeled imitation dairy products within 90 days and require the FDA to report to Congress two years after enactment to hold the Agency accountable for this update in their enforcement obligations. A press release from Baldwin’s office about the Act, explains that FDA has not enforced regulations that define dairy products as being from dairy animals and that has “led to the proliferation of mislabeled alternative products that contain a range of ingredients and nutrients that are often not equivalent to the nutrition content of dairy products.”
  • Last year, FDA published in the Federal Register a solicitation for public comment regarding the use of the names of dairy foods in the labeling of plant-based products (for more details see our blog on FDA’s request for comments). The comment period, originally scheduled to end on November 27, 2018, was extended to January 28, 2019. Noting that the comment period has ended, Sens. Baldwin and Risch, Crapo, King, and Leahy wrote a letter to FDA Commissioner Scott Gottlieb and Deputy Commissioner for Food and Policy Response Frank Yiannas on March 14 encouraging them to move forward quickly to begin enforcing FDA’s Standards of Identity for dairy products.
  • As previously reported on this blog, FDA’s solicitation for comments on the use of dairy terms in labeling plant-based product resulted in more than 13,000 comments, with strong opinions on both sides. We will continue to report on this strongly debated issue.

 

  • The California Office of Environmental Health Hazard Assessment (OEHHA) has tasked the Developmental and Reproductive Toxicant Identification Committee (DARTIC) of OEHHA’s Science Advisory Board with evaluating whether cannabis (marijuana), marijuana (cannabis) smoke, cannabis extracts, and Δ-9-Tetrahydrocannabinol (THC) have been shown to cause reproductive toxicity (developmental toxicity endpoint).  Chemicals identified as reproductive toxicants by the DARTIC are added to the Proposition 65 list.
  • OEHHA is initiating the development of hazard identification materials on cannabis chemicals and is requesting scientific information relevant to whether they cause reproductive toxicity (developmental toxicity endpoint).  The data call-in period will end at 5:00 p.m. on April 29, 2019.  The committee meeting is tentatively planned for Fall 2019, but the exact date is yet to be determined.
  • This Proposition 65 development occurs after the U.S. Food and Drug Administration (FDA) showed signs of potentially loosening its opposition to the inclusion of cannabidiol extracts in food or dietary supplements.  As reported in this blog, FDA Commissioner Scott Gottlieb had announced the formation of a working group to develop rules that would permit the use of certain extracts from hemp in food or dietary supplements and indicated that a public hearing was being planned for April to discuss how some uses of cannabidiol in food and dietary supplements might be legalized.  FDA’s website has no details about an April hearing and it is not clear if Commissioner Gottlieb’s plans to leave FDA at the end of the month will slow work on this matter.
  • Keller and Heckman LLP attorneys actively advise clients on compliance issues and enforcement actions related to California’s Proposition 65 and the evolving regulatory status of cannabis-related ingredients.  If you have any questions about the data call-in for cannabis or other issues, please email prop65@khlaw.com.
  • In February 2018, The Daily Intake Blog reported that the U.S. Department of Health and Humans Services (HHS) and the U.S. Department of Agriculture (USDA) were soliciting “public comments on the proposed priority topics and supporting scientific questions that will guide the development of the upcoming 2020-2025” edition of the Dietary Guidelines for Americans (the 2020 DGA).  The DGA is a set of recommendations intended to help people make healthy eating choices and it has been of particular interest as the U.S. Food and Drug Administration (FDA, an agency within HHS) attempts to define “healthy”
  • USDA published the topics that the Dietary Guidelines Advisory Committee (the Committee) is to address in providing guidance to HHS and USDA.  As expected, HHS and USDA have asked the Committee to stratify and review evidence based on age (and stage of life), sex, race, ethnicity, culture, location, and/or socioeconomic status.  Specific topics include:
    • Current patterns,
    • Nutrients of public health concern,
    • Prevalence of nutrition-related chronic health conditions,
    • Dietary pattern shift with life stage,
    • Impact of
      • dietary pattern on growth and disease,
      • beverages on growth, achieving nutrient and food group recommendations, and disease,
      • added sugars on growth, achieving nutrient and food group recommendations, and disease,
      • dietary fats on brain health and various diseases,
      • seafood on brain health and various diseases,
      • frequency of eating on growth and disease, and
    • Infant and Toddler (birth through 24 months) and  Pregnant and Lactating Mother specific questions
  • The Committee will be holding its first meeting on March 29 at the USDA South Building, Jefferson Auditorium, in Washington, DC and via webcast.  The meeting is open to the public, but attendees (in-person or via webcast) must register between March 19 and March 26.  The agenda includes:
    • review of operations for the Committee members,
    • overview of the topics and questions identified by the Departments [HHS and USDA] to be examined by the Committee,
    • presentations on evidence-based approaches for reviewing the scientific evidence, and
    • plans for future Committee work
  • Keller and Heckman will continue to monitor and report on developments relating to the DGA.
  • On March 13, 2019, FDA proposed to end the Agency’s current compliance policy on flavored e-cigarettes (other than tobacco-, mint-, and menthol-flavored products), as well as its policy on flavored cigars, in an effort to curb youth smoking rates.  The compliance policy permits “deemed” tobacco products on the market when FDA’s Deeming Rule went into effect on August 8, 2016 to remain on the market until premarket applications are due. Commissioner Scott Gottlieb stated, “Our proposal reflects a very careful public health balance between closing the on-ramp for kids to become addicted to nicotine through tobacco products, while allowing for the promise of an off-ramp for adult smokers through access to potentially less harmful forms of nicotine delivery.”
  • In its new draft guidance, FDA also describes focusing its enforcement resources on retail stores “where minors can enter at any time” (e.g., brick-and-mortar convenience stores and online stores with inadequate age-verification software).  FDA also puts pressure on manufacturers to use their powers to dictate “terms, conditions, or controls in their contracts with downstream distributors (wholesalers, distributors, importers and/or retailers)” to prevent youth access when sold at retail.  This position is consistent with its recent enforcement actions against Walgreens and Circle K stores for youth sales.
  • The draft guidance would require manufacturers of all flavored e-cigarette and e-liquid products (other than tobacco-, mint-, and menthol-flavored) to submit premarket applications to the agency by August 8, 2021—one year earlier than previously proposed, which is sure to be a blow to the e-cigarette industry.  FDA expects that these policy changes will result in a number of e-cigarette and flavored cigars — which  will have to be removed entirely from the market absent FDA marketing authorization — no longer being sold.
  • FDA is accepting comments on its draft guidance for 30 days.  For more details on this and other tobacco-related news, please see our Continuum of Risk Blog.
  • FDA released the second installment of a draft guidance designed to support compliance with the Intentional Adulteration (IA) rRule under the Food Safety Modernization Act (FSMA). The first installment was published in June 2018, and a third installment is to follow.
  • The second installment outlines two flexible methods for how facilities can conduct vulnerability assessments to identify areas of highest risk, as well as details the mitigation strategies required to significantly minimize or prevent significant vulnerabilities that have been identified. The draft guidance also provides information about education and training requirements for individuals who perform certain activities under the IA rule.
  • FSMA’s final IA rule is designed to address hazards that may be intentionally introduced to foods, including by acts of terrorism, with the intent to cause wide-spread harm to the public health. Unlike other FSMA rules that address specific foods or hazards, the IA rule requires the food industry to implement risk-reducing strategies for processes in food facilities that are significantly vulnerable to intentional adulteration. In the 2016 IA final rule, FDA identified four key activities that are most vulnerable to intentional adulteration: (1) bulk liquid receiving and loading, (2) liquid storage and handling, (3) secondary ingredient handling, and (4) mixing and similar activities.
  • Stakeholders may submit comments on this IA draft guidance until July 5, 2019. Keller and Heckman attorneys are well-versed in FSMA provisions and are available assist interested parties in preparing comments for submission to FDA. For assistance, please email: fooddrug@khlaw.com