FDA Authorizes Qualified Health Claim for Oleic Acid

  • A health claim characterizes the relationship between a substance and its ability to reduce the risk of a disease or health-related condition (see 21 CFR 101.14). A health claim must contain the elements of a substance and a disease or health-related condition. In addition, health claims are limited to claims about disease risk reduction, and cannot be claims about the diagnosis, cure, mitigation, or treatment of disease. Health claims are required to be reviewed and evaluated by FDA prior to use via a petition process. There are two types of health claims that can be approved by FDA : (1) authorized health claims that meet the standard of significant scientific agreement (SSA) and (2) qualified health claims. A “qualified health claim” must be accompanied by qualifying language or a disclaimer communicating the level of scientific evidence supporting the claim.
  • On November 19, 2018, FDA announced that it intends to exercise enforcement discretion for the use of a qualified health claim suggesting that consuming oleic acid in edible oils, such as olive oil, sunflower oil, or canola oil, may reduce the risk of coronary heart disease. Responding to a petition filed by Corbion Biotech, Inc., the Agency noted that while there is credible evidence to support a qualified health claim for oleic acid, the evidence does not meet the more rigorous “significant scientific agreement” standard required by an authorized health claim. Therefore, FDA stated that it intends to exercise enforcement discretion for the following qualified health claims:
    • “Supportive but not conclusive scientific evidence suggests that daily consumption of about 1½ tablespoons (20 grams) of oils containing high levels of oleic acid, when replaced for fats and oils higher in saturated fat, may reduce the risk of coronary heart disease. To achieve this possible benefit, oleic acid-containing oils should not increase the total number of calories you eat in a day. One serving of [x] oil provides [x] grams of oleic acid (which is [x] grams of monounsaturated fatty acid).”
    • “Supportive but not conclusive scientific evidence suggests that daily consumption of about 1½ tablespoons (20 grams) of oils containing high levels of oleic acid, may reduce the risk of coronary heart disease. To achieve this possible benefit, oleic acid-containing oils should replace fats and oils higher in saturated fat and not increase the total number of calories you eat in a day. One serving of [x] oil provides [x] grams of oleic acid (which is [x] grams of monounsaturated fatty acid.”
  • In a statement about the qualified health claim, FDA Commissioner Scott Gottlieb explained that “modernizing and prioritizing new claims on food labels” is part of the Agency’s Nutrition Innovation Strategy. (For more information on FDA’s Nutrition Innovation Strategy, click here.)

Important Details Remain Unsettled Following USDA and FDA Announcement of Decision to Jointly Regulate Cell-Cultured Meat

  • As previously reported on this blog, the United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA) have both claimed regulatory oversight of cell-cultured meat, a product that some say could be available for marketing in as early as three years.  Federal law grants regulatory authority over meat products, poultry, catfish, and egg products to USDA.  FDA has regulatory authority over all other food in interstate commerce.  Jurisdictional issues impact cell-cultured meat from early decisions on premarket approval and labeling through daily operations going forward.  For example, USDA Food Safety Inspection Service (FSIS) inspectors are in federally inspected meat and poultry slaughter plants during all hours of operation and in meat, poultry, catfish and egg processing plants for at least a brief period each shift, whereas FDA inspections are on a periodic basis of one year or more between inspections.
  • FDA and USDA invited public input on the oversight of cell-cultured meat in a joint meeting on October 23-24, 2018.  Subsequently, in a November 16, 2018 joint press release, USDA and FDA announced an agreement on a joint regulatory framework (although the framework itself was not released) wherein FDA will oversee cell collection, cell banks, and cell growth and differentiation.  USDA oversight would begin during the cell harvest stage and continue through the production and labeling of food products derived from the cells of livestock and poultry.  Since cell-cultured products do not necessarily have the same food safety concerns as meat and poultry harvested from animals, it is unclear if USDA jurisdiction from the cell harvest stage forward means that daily in-plant inspect will be required.
  • Regarding speculation that Congress may have to settle the USDA-FDA jurisdictional issue, the joint press release asserts no new legislation is needed to regulate cell-cultured food products derived from livestock and poultry.  However, no statutory authority was cited.  In this regard, the definition of “meat food product” in the Federal Meat Inspection Act as “any product capable of use as human food which is made wholly or in part from any meat or other portion of the carcass,” does not clearly encompass food from tissue cultured cells.  See 21 USC 601(j) (emphasis added).  Although not mentioned in the press release, cell-cultured fish (other than catfish) and seafood would be under FDA’s sole jurisdiction.
  • As USDA and FDA actively work on the numerous technical details of the joint regulatory framework, the period for public comment has been extended and will remain open through December 26, 2018.

FDA Announces New Steps to Protect Youth From Tobacco Harms; National Youth Tobacco Survey Results Released

  • On November 15, FDA and the Centers for Disease Control (CDC) published the results of the National Youth Tobacco Survey (NYTS).  As summarized in their joint Statement, the “NYTS is a cross-sectional, voluntary, school-based, self-administered, pencil-and-paper survey of U.S. middle and high school students.”  Results of the survey showed a 78 percent increase from 2017 to 2018 in high school students who identify as current e-cigarette users and a 48 percent increase amongst middle schoolers (up to 3.05 and 0.57 million users respectively).  Dr. Scott Gottlieb, commissioner of FDA, and Department of Health and Human Services (HHS) Secretary Alex Azar state that “These new data show that America faces an epidemic of youth e-cigarette use.”
  • As previously reported on this blog and on Keller and Heckman’s Continuum of Risk blog, Dr. Gottlieb has taken steps to curb use by youth, including calling for voluntary action by five manufacturers of electronic nicotine delivery systems (ENDS) that make up 97 percent of the cartridge-based ENDS market.  Dr. Gottlieb has indicated that FDA would also take regulatory steps to help reduce use by youth.  In the past week, FDA has hinted through the media that new policies would be announced in the near future.
  • Concurrent with the release of the NYTS results, Commissioner Gottlieb on November 15 issued a statement detailing FDA’s updated policies to help protect youth by preventing their access to tobacco products, particularly flavored cartridge-based ENDS.  These policies include:
    • Restricting in-person sales of all flavored ENDS (except mint, menthol, and tobacco flavor) to adult (18+) only facilities such as vape shops;
    • Requiring, soon-to-be-announced, “heightened” age-verification for online sales of flavored ENDS;
    • Proposing a rule to eliminate all flavored cigars from the market;
    • Continued enforcement against youth appealing vape products, including those marketed to youth via children’s cartoon or animated characters or by imitating products favored by kids; and
    • Proposing a rule to ban menthol cigarettes from the market.
  • For more on FDA’s new policies check the Continuum of Risk blog post.  Register for Keller and Heckman’s 3rd Annual Tobacco and E-Vapor Law Symposium in Miami, Florida on January 29-30, 2019 here.

CDC Issues Update on Multistate Salmonella Outbreak Linked to Raw Turkey

  • An outbreak of Salmonella Reading linked to raw turkey that began in November 2017 continues to sicken Americans in 35 states.  Raw turkey pieces, ground turkey, whole turkey, and turkey pet food have been linked to illnesses in humans.
  • A total of 164 people have been infected, 47% of whom have been hospitalized.  There has been one fatality in California.  The CDC reports that 68 isolates from ill people and 84 isolates from food contained genes for resistance to all or some of 10 listed types of antibiotics but notes that “most of the infections in this outbreak are susceptible to the antibiotics that are commonly used for treatment, so this resistance will not affect the choice of antibiotic resistance used to treat most people.”
  • The Center for Science in the Public Interest has criticized the U.S. Department of Agriculture for not identifying the 22 slaughter and 7 processing establishments where Salmonella Reading has been detected and determined to be “closely related genetically to the strains isolated from ill people.”  While FDA recently took steps to increase transparency and provide consumers will more “actionable information” in food recall situations, USDA has not yet expressed an interest in increasing transparency during food recalls.

Post-Election, Oregon and Washington’s Proposed Soda Tax Bans Reach Different Results

  • As previously reported on this blog, Oregon and Washington state residents headed to the polls on November 6, 2018 to vote on initiatives that would preemptively ban new soda and food taxes. Despite similarities in terms of context and likelihood to succeed, the two initiatives came to very different results. Oregon’s Measure 103 was defeated, with 57.7% “No” votes to 42.3% “Yes” votes, whereas Washington’s Initiative 1634 was approved after receiving 54.8% “Yes” votes to 45.2% “No” votes.
  • As a reminder, Oregon’s Measure 103 would have amended the state constitution to prohibit the state and local governments from passing taxes on groceries, defined as “raw or processed food or beverages intended for human consumption,” excluding alcohol, tobacco, and marijuana. Thus, Measure 103 would have prevented the taxing of soda or sugary beverages. Prior to the election, Oregon did not have a statewide sales tax—including on groceries—but also had no law preventing local governments from establishing such a sales tax.
  • Washington’s Initiative 1634, also known as the Prohibit Local Taxes on Groceries initiative, prohibits local governments from passing new taxes or fees on groceries, defined as “any raw or processed food or beverage, or any ingredient thereof, intended for human consumption.” Groceries include, but are not limited to, meat, produce, grains, dairy, seasonings, and condiments. Alcoholic beverages, tobacco, and marijuana products do not qualify as grocery items and are not exempt from new taxes. As discussed in our January 2, 2018 blog, the city of Seattle enacted a soda tax, which went into effect in January 2018. While Washington’s newly approved initiative will not repeal the Seattle soda tax, it will prevent other cities and local governments in the state from passing similar taxes.  Notably different from the Oregon initiative, Washington’s Initiative 1634 does not prevent the state from imposing taxes on groceries Additionally, the initiative prohibits any existing taxes, fees, or assessments from being increased.
  • As expected, both Oregon and Washington’s initiatives garnered much criticism. Critics of both initiatives say the true purpose of the laws is not to prevent taxes on groceries or rising food costs, but to ban soda and sugar-sweetened beverage taxes altogether. Similarly, critics likened these measures to strategies deployed by the tobacco industry in opposing city ordinances aimed at secondhand smoke. However, proponents of the measures, such as the American Beverage Association, argued that such taxes are ineffective, discriminatory, and responsible for increasing food costs. Needless to say, in light of the criticism and mixed election results, Oregon and Washington’s initiatives indicate that the battle over soda taxes wages on.

New Report Reveals Sources of Foodborne Illnesses

  • On November 9, 2018, the Interagency Food Safety Analytics Collaborations (IFSAC) released a report on foodborne illnesses caused by four pathogens. The data in the report, titled, “Foodborne illness source attribution estimates for 2016 for Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter using multi-year outbreak surveillance data, United States,” came from 1,255 foodborne disease outbreaks that occurred from 1998 through 2016. According to the report:
    • Salmonella illnesses came from a wide variety of foods;
    • E. coli O157 illnesses were most often linked to Vegetable Row Crops (such as leafy greens) and Beef;
    • Listeria monocytogenes illnesses were most often linked to Dairy products and Fruits; and
    • Campylobacter illnesses were most often linked to Chicken after removing Dairy outbreaks from the estimates.
  • The analysis to develop the report involved a method developed by IFSAC to estimate foodborne illness source attribution (see our blog on IFSAC research on how to categorize foods linked to foodborne disease outbreaks). IFSAC includes the Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA-FSIS).
  • Each year in the United States, foodborne disease caused by known pathogens results in an estimated 9 million people becoming sick, 56,000 hospitalizations, and 1,300 deaths, according to the report. The pathogens in the report were chosen because of the frequency or severity of the illnesses they cause. CDC estimates that, combined, the four pathogens cause 1.9 million foodborne illnesses in the United States each year. The four pathogens also were selected because targeted interventions can have a major impact in reducing foodborne illness caused by these pathogens.

Stakeholder Comments Reflect Discontent with FDA’s Draft Guidance for Quantitative Labeling of Supplements Containing Live Microbials

  • FDA’s regulation on nutrition labeling of dietary supplements requires that dietary ingredients for which a Reference Daily Intake (RDI) or Daily Reference Value (DRV) has not been established must be listed inside the Supplement Facts label along with their quantitative amount by weight per serving in metric units, as described in 21 CFR 101.36(b)(3).  For microbial ingredients in probiotic products, the weight of the cellular mass (which can include dead and injured cells) does not necessarily correlate with the number of viable microorganisms in the product.
  • In finalizing its May 2016 amendment of the labeling regulations for conventional foods and dietary supplements, FDA declined a request to “permit the use of additional units of measure for dietary ingredients to allow for use of more appropriate units of measure when metric weight is not the most accurate way to express the quantity of the dietary ingredient,” and cited the need for more time to evaluate the matter.  FDA subsequently received a citizen petition from the International Probiotics Association (IPA) requesting that the permitted unit for reporting live microbials be changed from weight to colony forming units (CFUs) in the regulation.
  • As reported here, FDA’s September 2018 draft guidance (Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials) reflected FDA’s decision to delay acting on IPA’s petition, and announced conditions under which the agency would in the interim exercise enforcement discretion for the declaration of the quantity of live microbials in CFUs in addition to weight.  FDA received 1,958 comments on the draft guidance before the comment period closed on November 6, 2018.  The Consumer Healthcare Products Association (CHPA), Council for Responsible Nutrition (CRN), and other stakeholder groups argue that requiring companies to list both the quantitative amount as weight (in mg) and as CFUs will present information on product labels in a way that is potentially misleading and will likely result in consumer confusion.  IPA further asserts that labeling only CFUs complies with the law because the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 343(q)) requires labeling to include the quantity of a nutrient but does not prescribe any specific unit of measure.
  • Since comments on IPA’s petition reflect wide – but not unanimous – industry support for mandatory listing of CFUs for microbial ingredients, and new methods for quantifying live microbes – including flow cytometry – are still in the research phase, we are convinced that FDA will not promulgate a regulation on listing CFUs at this juncture and is also very unlikely to revise its current enforcement policy to drop the requirement for listing the weight of microbial ingredients.


FDA Announces Meeting to Discuss Eliminating Youth E-Cigarette Use

  • On September 12, 2018, FDA Commissioner Dr. Scott Gottlieb announced FDA’s Youth Tobacco Prevention Plan in response to the perception that use of e-cigarettes has become an “epidemic”.  Dr. Gottlieb’s concern is based on preliminary data from the National Youth Tobacco Survey, expected out in November, which suggests that the number of high-school-age children reporting use of e-cigarettes increased more than 75 percent from 2017 to 2018. As part of its effort, FDA sent letters inquiring about marketing practices to five manufacturers of cartridge based e-cigarette products that are widely used by youth. The letters suggest that FDA might ban flavored e-liquids if insufficient steps to curb youth use are not taken.
  • On November 2, 2018 FDA announced a pubic meeting on December 5, 2018 to discuss continued efforts to curb e-cigarette use and to aid cessation amongst youth. Topics of interest noted in Dr. Gottlieb’s press release focus on cessation and include:
    • Potential role of drug therapies to support cessation of e-cigarettes and traditional tobacco products use (including cigarettes and smokeless tobacco) amongst youth;
    • Behavioral interventions to aid in cessation;
    • Development of cessation drugs;
    • Development of methods, study designs, and measures for evaluating drugs for use in youth cessation; and
    • Funding opportunities for research on youth use, attitudes, and cessation
  • A November 8, 2018 article in the Washington Post indicates that FDA may, as early as next week, impose severe restrictions on the sale of flavored e-cigarette products in convenience stores and gas stations.  The ban would only apply to cartridge-based products.
  • 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.

FDA Releases Initial Findings on Food Safety in Restaurants

  • According to the Centers for Disease Control and Prevention (CDC), more than half of foodborne illness outbreaks that occur each year are associated with food from restaurants. CDC has identified five major risk factors related to food safety practices within the retail food industry that contribute to foodborne illness: (1) poor personal hygiene; (2) improper food holding/time and temperature; (3) contaminated equipment/protection from contamination; (4) inadequate cooking; and (5) food obtained from unsafe sources.
  • FDA previously conducted a 10-year study between 1998-2008 to measure trends in the occurrence of foodborne illness risk factors and food safety behaviors/practices in the retail food industry. At that time, FDA concluded that many segments of the retail food industry required improvement in three areas: (1) poor personal hygiene; (2) improper food holding/time and temperature; and (3) contaminated equipment/protection from contamination. Ultimately, FDA determined it needed to continue to study effective intervention strategies and inspection approaches for the retail food setting.
  • On November 7, 2018, FDA released its initial set of findings of a ten-year study, which started in 2013 and will conclude in 2023, on foodborne illness risk factors in fast food and full service restaurants.  Ultimately, key findings from the restaurant data highlight the importance of food safety management systems, including certified food protection managers. Of the food safety practices investigated, restaurants had the best control over ensuring no bare hand contact with ready-to-eat foods and cooking raw animal foods to their required temperatures. The study showed there remains a need to gain better control over employee handwashing and proper temperature control of foods that require refrigeration (cold holding of foods). Additional data collections in 2015, 2019, and 2023 investigate similar retail food safety research questions in institutional food service settings and retail food stores and will be made available once completed.

Days after Joint FDA/USDA Meeting on Cell Culture Technology, GFI and Others Request Preliminary Injunction on Missouri Law Banning Use of “Meat” on Plant-Based Product Labels

  • As previously reported on this blog, the Good Food Institute (GFI), the Animal Legal Defense Fund, the American Civil Liberties Union of Missouri, and Turtle Island Foods (Tofurky brand) sued the state of Missouri over a new law, Mo. Rev. Stat. § 265.494(7), which prohibits labeling a product that is not derived from harvested production livestock or poultry as meat. No other state has enacted a similar law.
  • In the lawsuit, filed in the U.S. District Court for the Western District of Missouri on August 27, 2018, the plaintiffs argue that, “the Statute is a content-based, overbroad, and vague criminal law that prevents the sharing of truthful information and impedes competition by plant-based and clean-meat companies in the marketplace.” Furthermore, they claim that the Statute does not protect the public from potentially misleading information and, therefore, violates the Free Speech Clause of the First Amendment.
  • On October 30, those plaintiffs filed a motion for a preliminary injunction at the U.S. District Court for the Western District of Missouri, Central Division. The groups argued that the law should not be enforced until there has been a legal ruling on whether the statute is constitutional. Plantiffs’ request for a preliminary injunction comes just days after a joint FDA/USDA meeting to discuss the use of cell culture technology to develop products derived from livestock and poultry. While it is still unclear which agency will take the lead in the regulation of cell-culture meat products, with USDA Secretary Sonny Perdue stating there should be “bright lines” in carving out rules for FDA and USDA, it is without question that those agencies are moving toward regulation of these products at the federal level. Oversight and regulation at the federal level may likely impact the Missouri law, so we will continue to report on regulatory activity in this area.

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