FSIS Publishes Updated Guidelines for “Non-GMO” Labeling Claims

  • On December 30, 2019, USDA’s Food Safety and Inspection Service (FSIS) published updated labeling guidelines on “Statements That Bioengineered or Genetically Modified Ingredients or Animal Feed Were Not Used in the Production of Meat, Poultry, or Egg Products.” The guidelines, which were originally announced in August 2016, outline the agency’s approach of approving labels containing “not-bioengineered,” “not genetically modified,” or similar language (i.e., “negative claims”), provided that the claims have been verified by a third-party certifying organization.
  • In response to comments, FSIS clarified in the updated guidelines that it will continue to approve negative claims based either on FDA’s definition of “modern biotechnology” or the Agricultural Marketing Service’s (AMS) definition of “bioengineering” contained in the National Bioengineered Food Disclosure Standard (NBFDS). The agency will also continue to allow the use of synonymous terms such as “genetically engineered” or “GE.”
  • As previously reported on this blog, AMS published the final rule for the NBFDS on December 21, 2018. The rule established detection requirements for the definition of “bioengineered food,” created a list of bioengineered foods, and provided disclosure options for labeling of bioengineered foods, among other provisions.

The Daily Intake will not publish on Monday, January 20, in recognition of Martin Luther King, Jr. Day. The next issue of The Daily Intake will publish on January 21, 2020.

Bipartisan Group of Representatives Introduces Bill that Would Give FDA Authority to Regulate CBD as a Dietary Supplement (Law360 subscription required)

  • On January 13, 2020, the House Agriculture Committee Chairman Collin Peterson (D- Minn.) introduced H.R. 5587, which would include hemp derived CBD in the definition of dietary supplements under the Federal, Drug and Cosmetic Act.  The bill would also require a study and report from the U.S. Department of Agriculture, which oversees the production of hemp, on the regulatory and market barriers for farmers engaged in hemp production.  This would inform growers and policy makers of the challenges facing this new industry.
  • This bill would essentially amend the Dietary Supplement Health and Education Act (DSHEA) by carving out a specific exemption for hemp derived CBD, as DSHEA currently states that a dietary supplement cannot include an article that is approved or under investigation for use in a new drug or biologic, unless that article was previously included in the food supply.  This will remove the barrier for FDA to consider the use of CBD in food, including dietary supplements; however, food companies that wish to use CBD ingredients in their foods remain subject to the relevant laws and regulations that govern all food products, including those that require that food additives obtain premarket approval or be determined to be Generally Recognized as Safe (GRAS) for their intended use.
  • H.R. 5587 was referred to the House Subcommittee on Health of the Committee on Energy and Commerce, which is scheduled to hold a legislative hearing on cannabis policies next week.  We will continue to monitor any developments.

FDA Responds to Three Dietary Fiber Citizen Petitions

  • On January 10, the FDA announced that it intends to propose that “glucomannan” be added to the definition of dietary fiber at 21 CFR 101.9(c)(6)(i). Based on available evidence, FDA determined that the scientific evidence suggests that glucomannan can help reduce blood cholesterol.  Glucomannan is commonly found in the tuber or root of the elephant yam, also known as the konjac plant. The FDA’s action is in response to a Citizen Petition (CP) filed by The Food Lawyers on February 24, 2018.
  • FDA also denied two CPs on January 13 for isomaltooligosaccharide (IMO), which were submitted by Top Health Ingredients in April 2019, and BioNeutra North America in May 2019. In both denials, FDA stated that “the strength of the evidence does not show that the consumption of IMO has a physiological effect that is beneficial to human health.”
  • With the granting of the glucomannan CP, there are currently 17 categories of non-digestible carbohydrates (NDCs) (including a broad category of mixed plant cell wall fibers) that are either included in the definition of dietary fiber, or are non-digestible carbohydrates that FDA intends to propose to be added to the definition of dietary fiber. Those NDCs are as follows: beta-glucan soluble fiber, psyllium husk, cellulose, guar gum, pectin, locust bean gum, hydroxypropylmethylcellulose, mixed plant cell wall fibers, arabinoxylan, alginate, inulin and inulin-type fructans, high amylose starch (resistant starch 2), galactooligosaccharide, polydextrose, resistant maltodextrin/dextrin, cross linked phosphorylated RS4, glucomannan.
  • There are currently 5 pending dietary fiber CPs that have been submitted for Agency review. Notably, some CPs have been under FDA review for upwards of 9 months or more. FDA states the CPs will be reviewed on a rolling basis, with the most recent CP submitted in December 2019 for alpha-cyclodextrin.

FDA’s New Enforcement Priority Guidance for E-Cigarettes Focuses on Flavored Cartridge-Based Devices and Companies and Products that FDA Views as Targeting Kids

On January 8, 2020 FDA published its new final compliance policy guidance, Guidance for Industry: Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization (January 2020), which goes into effect in February. Under the final guidance, beginning February 6, 2020, FDA intends to prioritize enforcement of premarket review requirements for the following products:

  1. Any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored ENDS product);
  2. All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access; and
  3. Any ENDS product that is targeted to minors or likely to promote use of ENDS by minors.

Importantly, FDA also intends to prioritize enforcement of any ENDS product (on the market as of August 8, 2016) that is offered for sale after May 12, 2020, and for which the manufacturer has not submitted a premarket application (or after a negative action by FDA on a timely submitted application).  The May 12, 2020 deadline was initially established by a federal district court in Maryland; that decision is now pending appeal in the Fourth Circuit.

While FDA has identified flavored cartridge-based ENDS as a primary concern for underage use, the Agency is also targeting manufacturers that are not adequately preventing minor access, and any products (open or closed system, including e-liquids sold in vape shops) that, in FDA’s view, are targeted to minors or likely to promote ENDS use by minors. FDA’s broad approach could put a significant portion of the vapor industry is at risk of immediate enforcement.

When determining whether a manufacturer is taking or has taken adequate measures to prevent minors’ access to ENDS products, the Agency will consider, for example:

  • Whether adequate programs to monitor retailer compliance with age-verification and sales restrictions have been implemented;
  • Whether retailers face manufacturer-established penalties for failing to comply with age verification and sales restrictions, and whether there is a policy of notifying FDA of retailer violations;
  • If the manufacturer is also a retailer, whether there is an implementation of programs to ensure age-verification and sales restrictions, checking ID at the door, etc.;
  • Whether the manufacturer uses adequate age-verification technology or requires that retailers use such technology to prevent minor access to its website and underage internet sales; and
  • Whether a manufacturer limits or requires retailers to limit the quantity of ENDS products that a customer may purchase in a given period of time.

When determining whether an ENDS product is targeted to minors or is marketed in a manner that is likely to promote ENDS use by minors, the Agency will consider, for example:

  • Whether the labeling and/or advertising of a product resembles kid-friendly foods and drinks or resemble other non-ENDS products that are appealing to youth. Here FDA highlights the numerous warning letters issued to e-liquid manufacturers over the last couple of years.  Those warning letters alleged that the e-liquid products were misbranded because the labeling and/or advertising of the products (i.e., color schemes, label images, brand names, etc.) inappropriately imitated specific food products that are generally marketed toward and/or appealing to children, including cereals (e.g., Cinnamon Toast Crunch, Lucky Charms, Fruit Loops, Franken Berry), candies and snacks (e.g., Life Savers, Sour Patch Kids, Gummy Worms, War Heads, Pocky Sticks, Goobers, Tree Top Apple Juice), and desserts (e.g., Unicorn Cakes, Nilla Wafers, Reddi Wip).
  • Whether marketing materials utilize youth appealing cartoon or animated characters, or use popular children’s characters and titles.
  • Whether paid social media influencers are used; and
  • Whether a product is promoted for being easily concealable (from parents and teachers). In this regard, FDA makes clear in the guidance that the following types of devices and device features present a unique concern for youth, even if adults may prefer these as well:
    1. Small size that allows for easy concealability and features that facilitate the ease of use (draw activation, prefilled cartridges or pods, and USB rechargeability);
    2. Small size that allow for use in school, quick concealment, product use in a social setting without others’ awareness, and products’ ability to be concealed with other equipment;
    3. Products with no settings to change and very little assembly required; and
    4. Products with features such as pre-filled cartridges, draw activated batteries, and that can be recharged via a USB ports, charging adapters or cell phone.

In short, while FDA’s focus is on the flavored cartridge and pod-systems, ENDS companies should be aware that FDA’s guidance is broad enough to capture a wide variety of open and closed-system products that may be viewed by FDA as accessible to kids, marketed to kids or easily used and/or concealed by kids.

Be sure to register for Keller and Heckman’s E-Vapor and Tobacco Law Symposium on February 11-12, 2020 in Irvine, California.  Details and Registration information can be found here.

Release by FDA, USDA, and EPA of New Joint Website on Biotechnology Regulation

 

  • The U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA) launched a Unified Website for Biotechnology Regulation on January 9, 2020.  According to the FDA News Release, this new website is part of President Donald J. Trump’s Executive Order on Modernizing the Regulatory Framework for Agricultural Biotechnology Products (“EO”) and its release was timed in recognition of January 2020 as National Biotechnology Month.
  • FDA currently has jurisdiction over the safety of most foods for humans and animals, including those produced using biotechnology; the safety and effectiveness of intentional genomic alterations in animals produced using biotechnology; and the safety and effectiveness of human and animal drugs and the safety, purity, and potency of human biologics, including drugs and human biologics from plants and animals produced using biotechnology.  We have reported on previous FDA and USDA responses pledging that ongoing biotechnology efforts at each Agency would continue in support of the EO for modernizing the regulatory framework for agricultural biotechnology products, and on FDA’s holding firm against claims of “undue regulation” and a call released by the pork industry soon after the release of the EO for shifting regulatory oversight of genetically engineered (GE) animals to USDA.
  • The new joint biotechnology website does not alter the existing federal review process for biotechnology products.  It seems that the website will serve mainly as a useful repository of links to background documents and the biotechnology programs at each agency.  The website also contains responses to a long list of “Frequently Asked Questions” and has a “Contact Us” feature that will allow users to submit additional questions to the three agencies.

 

California Finalizes the Listing of Cannabis (Marijuana) Smoke and Δ-9-Tetrahydrocannabinol as Reproductive Toxicants Under Proposition 65

  • As our readers may recall, the California Office of Environmental Health Hazard Assessment (OEHHA) 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 (Δ9-THC) have been shown to cause reproductive toxicity for purposes of listing under California’s Proposition 65 (“Prop. 65”). Marijuana smoke has been listed as a carcinogen since 2009. At a public meeting on December 11, 2019, DARTIC (in its official capacity as the “state’s qualified experts”) determined that cannabis (marijuana smoke) and Δ9-THC were shown to cause reproductive toxicity based on the developmental toxicity endpoint.
  • Effective January 3, 2020 (and subject to enforcement starting January 3, 2021), OEHHA finalized the listing of cannabis (marijuana) smoke and Δ9-THC as reproductive toxicants under Prop. 65. Due to the large volume of data received in response to its March 15, 2019 public request for information, however, OEHHA limited its review of evidence to the developmental toxicity of cannabis smoke and Δ9-THC, deferring evaluation of “[o]ther extracts of cannabis” for potential future consideration.
  • Due to the prior listing of marijuana smoke on Prop. 65 as a carcinogen, some marijuana smoke-based products may already bear Prop. 65 warnings addressing the cancer risk. The new listing, however, would require companies to reassess and consider expanding their warnings for cannabis (marijuana) smoke products to incorporate the reproductive toxicity endpoint. In addition, the new listing may reach cannabis products that contain Δ9-THC but do not expose individuals to smoke (such as edibles, cosmetics, beverages, vape cartridges, etc.), for potential warnings addressing reproductive toxicity.

Keller and Heckman attorneys routinely advise clients on compliance issues and enforcement actions related to California’s Prop. 65 and the evolving regulatory status of cannabis-related ingredients.

Mexican Chamber of Deputies Approves Bill that Prohibits Use of Dairy Terms on Plant-Based Alternatives

  • In late December 2019, Mexico’s Chamber of Deputies’ voted in favor of a reform to the Ley de la Propiedad Industrial (“Industrial and Federal Property of Consumer Protection law”), which would make regulations on misleading advertising more stringent.  This prohibition will have an impact on plant-based alternatives that currently use dairy terms, such as “soymilk” or “almond yogurt.”
  • The reform would amend articles 90 and 95 of the Industrial and Federal Property of Consumer Protection law, which would expand what constitutes false or misleading language, including the composition of products.  The president of the Livestock Commission, Eduardo Ron, noted that the draft bill “represents hope for thousands of small, medium, and large milk producers, who everyday face unfair practices in the market.”
  • The next step is for Mexico’s Chamber of Senators to review the amendments to the Industrial and Federal Property of Consumer Protection law.  Ron noted that the law would also apply to other products, like sugar-based syrup products that depict honeybees on their packaging, which confuses and misleads consumers.  We will continue to monitor any developments.

CSPI Asks FDA Not To Make Sweeping Changes to Food Standards of Identity

  • As our readers may recall, FDA held a public meeting on September 27, 2019, to discuss FDA’s efforts to modernize food Standards of Identity (SOI) and to provide information about changes the FDA could make to existing SOIs. Section 401 of the Federal Food, Drug, & Cosmetic Act gives FDA authority, whenever in its judgment it “will promote honesty and fair dealing in the interest of consumers, to promulgate regulations fixing and establishing for any food, under its common or usual name so far as practicable, a definition and standard of identity.” There are literally hundreds of food products for which standards of identity have been promulgated. These standards are set forth by product category in 21 C.F.R. Parts 131 through 169. The procedures for setting standards of identity, many of which were initiated by the food industry, are set forth at 21 C.F.R. Part 130.
  • On January 6, the Center for Science in the Public Interest (CSPI) sent Dr. Susan Mayne, the Director of FDA’s Center for Food Safety and Applied Nutrition (CFSAN) a letter urging the Agency not to make broadly conceived horizontal changes to SOIs, which as CSPI states, “could introduce unintended negative consequences and/or confuse consumers about the quality or nutritional value of foods.” Although CSPI supports the FDA’s efforts to re-examine the SOIs, CSPI urged the FDA to proceed with caution and ensure that any amendments to the SOIs are “targeted, clearly defined, and fully considered to support specific public health priorities.”
  • Overall, CSPI recommended the Agency review proposed amendments to SOIs in light of potential public health benefits and drawbacks, and also outlined 5 changes that the Agency should prioritize should the Agency wish to consider broad horizontal changes that cut across food categories:
    1. Issue regulations requiring the amount of key healthful ingredients to be declared
    2. Allow salt substitutes to be used in standardized foods where necessary to achieve sodium reduction targets.
    3. Maintain and expand key standards for enriched cereals.
    4. Require dairy substitutes to disclose when the product contains less of a key nutrient than the reference dairy food.
    5. Develop a streamlined process for reviewing other changes to standardized foods on a case-by-case basis.

We will continue to monitor updates on the FDA’s efforts to modernize SOIs.

FDA Issues Final Guidance Document on Nutrition Facts Label and Serving Size Rules

  • In May 2016, FDA issued final rules changing the Nutrition Facts label for packaged foods and updating regulations on serving sizes to – among other things – provide realistic Reference Amounts Customarily Consumed (RACCs).  Detailed summaries of both rules may be found here.  For manufacturers with $10 million or more in annual food sales, the compliance date is January 1, 2020.  For manufacturers with less than $10 million in annual food sales, the compliance date is January 1, 2021.  Products that are labeled (i.e., when the label is placed on the product) on or after the applicable compliance date must bear a nutrition label that meets the new nutrition labeling requirements.
  • On December 31, 2019, FDA announced a final guidance, titled ‘‘Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics,’’ which replaces FDA’s November 2018 draft guidance.  Changes include:
    • Providing additional background information on RACCs for non-juice beverages for infants and young children;
    • Clarifying a question and response concerning whether the Nutrition Facts label for products sold in small packages (e.g., certain sugar-free chewing gums) must list all nutrients that are contained in insignificant amounts; and
    • Modifying the response to a question regarding the placement of the Nutrition Facts and Supplement Facts labels to clarify that the Nutrition Facts or Supplement Facts label should not be placed on the bottom of packages (such as the bottom of boxes, cans, and bottles), unless they are visible during normal retail display and consumer handling.
  • The final guidance reiterates that FDA will exercise enforcement discretion with respect to certain bottled water products, coffee beans, tea leaves, plain unsweetened coffee and tea, condiment-type dehydrated vegetables, flavor extracts, and food colors that do not meet the new requirements until a future rule specific to labeling requirements for those products is enacted.
  • Keller and Heckman attorneys are well-versed in nutrition labeling and serving size requirements and would be happy to assist with any questions about compliance with FDA’s final rules.

 

Bipartisan Senate Bill Would Formalize FDA-USDA Jurisdiction over Cell-Based Meat

  • Senators Mike Enzi (R-WY) and Jon Tester (D-MT) have introduced a bill, the “Food Safety Modernization for Innovative Technologies Act,” that would formalize the agreement between FDA and USDA to jointly regulate cell-based meat products.
  • Consistent with the March 2019 agreement between the two agencies, the bill would give FDA authority to evaluate the technology of producing cell-based meat from livestock or poultry cells, while USDA would oversee the processing, packaging, and labeling of such products.  For products not derived from livestock or poultry cells, FDA would have sole jurisdiction.
  • The bill is the latest effort to propose a formal regulatory system to address cell-based meat and would create definitions for adulteration and misbranding applicable only to food produced using animal cell culture technology.  In the meantime, states continue to introduce bills to limit the ability to market cell-based meat products as “meat,” and the meatless food industry continues to grow.

The next issue of The Daily Intake will publish on January 6, 2020. Keller and Heckman LLP wishes everyone a wonderful holiday season.

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