Arkansas Passes Resolution Calling for Standard for Rice

  • Over the last year, dairy industry groups have appealed to FDA and Congress to enforce the standard of identity for milk with regard to plant-based beverages labeled as “milk,” for example “soy milk”.  The dairy industry argues that milk is defined as “the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows” (21 C.F.R. Section 131.110) and that plant-based beverages do not meet this standard.  Those wishing for plant-based beverages to retain the ability to use a name including the plant source and the word “milk” argue that such a name provides context for consumers while making the plant-based origins of the beverage clear.  See Daily Intake posts on the topic here, here, and here.
  • Now,  the rice industry is interested in ending the practice of naming vegetables that have undergone a process known as ricing from being labeled as “rice” preceded by the vegetable type, for example “cauliflower rice.”  The industry argues that the use of the term rice is misleading to consumers who might expect the vegetable rice product to contain Oryza sativa L. or wild rice defined by the four species of grasses from the genus Zizania.  See our blog post on the topic from May 2017.
  • Arkansas, a major producer of rice in the United States, recently passed a resolution to set a standard for rice, urged Federal regulators to set a standard for rice,  and take action against vegetable rice products that do not contain any Oryza sativa L. or wild rice.
  • If a federal standard of identity for rice is established, the argument that riced vegetables cannot use rice in their names would be strengthened.  The battle over whether plant-based beverages can include “milk” in their names will be predictive, especially if plant-based beverages are allowed to continue using “milk” in their names.

California Considers Regulating Food Packaging under Green Chemistry Initiative

  • As part of its Green Chemistry Initiative and the Safer Consumer Products (SCP) implementing regulations, California’s Department of Toxic Substances Control (DTSC) has released its Draft Three Year Priority Product Work Plan (2018-2020).  The Plan indicates that it will “address exposures from harmful chemicals that migrate from consumer products into food.”
  • DTSC identifies as “Candidate Chemicals” in food contact materials:  (1) Bisphenol A and Bisphenol S as a “constituent in plastic resin lining food and beverage cans,” (2) perfluoroalkyl and polyfluoroalkyl substances which “create grease-proof and water-proof coatings for food packaging;” (3) phthalates as plasticizers; and (4) styrene as a “constituent of polystyrene and rubber products.”
  • Five NGOs (i.e., the Center for Environmental Health (CEH), Environmental Working Group (EWG), Clean Water Action (CWA), Breast Cancer Prevention Partners, and UpStream) submitted comments supporting the inclusion of food contact materials in the Draft Work Plan.  DTSC will now develop information through research, information call-ins, and public workshops to decide whether to regulate food packaging as a Priority Product.  To date, only children’s foam-padded sleeping products containing tris (1,3-dichloro-2-propyl) phosphate (TDCPP) or tris (2-chloroethyl) phosphate (TCEP) have been officially regulated as a Priority Product, effective July 1, 2017.)

FDA Guidance States Live Animals Processed Under USDA Regulations Do Not Need to Comply with FSVP Regulations

  • On March 21, 2018, the U.S. Food and Drug Administration (FDA) published guidance that live animals processed under Department of Agriculture (USDA) regulations do not need to comply with Foreign Supplier Verification Program (FSVP) requirements.
  • In general, live animals imported for use as food are regulated by FDA. However, they are required to be slaughtered under mandatory inspection by the USDA’s Food Safety and Inspection Services (FSIS), and processed at USDA-regulated establishments that are subject to USDA-administered hazard analysis and critical control point (HACCP) requirements. While the FSVP regulation explicitly provides an exemption for certain food (i.e., certain meat, poultry, and egg products) that is subject to certain USDA requirements at the time of importation, the exemption does not include live animals that are imported for use as food.
  • The guidance explains that FDA intends to exercise enforcement discretion regarding the application of the FSVP rule to importers of live animals that must be slaughtered and processed at establishments regulated by USDA and subject to HACCP requirements. This means the agency does not intend to enforce the FSVP requirements that these importers would otherwise have to meet.
  • However, FDA’s enforcement discretion does not apply to importers of other live animals intended for use as food (e.g., farmed bison, deer, elk), the slaughtering and processing of which is under FDA’s jurisdiction, or to animals that are subject to FDA jurisdiction for slaughtering, but are slaughtered under voluntary inspection by FSIS.

FDA Issues Draft Guidance on “Small Business” under FSMA Preventive Controls Regulations

  • As previously reported on this blog, FDA published final rules to implement the Hazard Analysis and Risk-based Preventive Control (HARPC) provisions for human and animal food under the FDA Food Safety Modernization Act (FSMA) on September 17, 2015. Small businesses may be eligible for certain exemptions and have later compliance dates than larger businesses covered by these rules.
  • On March 19, 2018, FDA released a draft guidance to assist businesses in determining their size under the Preventive Controls regulations. A “small business” is defined in the rules as a business (including any subsidiaries or affiliates) employing fewer than 500 full-time equivalent employees. The draft guidance explains terms such as “subsidiary,” “affiliate” and “full-time equivalent employee.” It also provides a method for calculating full-time equivalent employees, and gives examples of the types of situations businesses might encounter when trying to determine their number of employees.
  • More information concerning about FDA’s final rule for Preventive Control for Human Food and for Preventive Controls for Animal Food can be found here and here.

First Amendment constraints on FDA’s regulation of health claims

  • On February 20, 2018, the Food and Drug Administration (FDA) denied a petition for a health claim for the consumption of cranberry products and the reduction in risk of recurrent urinary tract infection (UTIs) in healthy women and notified Ocean Spray that FDA will instead review the petition as a request for a qualified health claim instead under the Better Nutrition Information for Consumer Health Initiative (July 10, 2003), which is implemented by FDA guidance documents, (1) Interim Procedures for Qualified Health Claims in the Labeling of Conventional Food and Human Dietary Supplements and (2) Interim Evidence-based Ranking System for Scientific Data.
  • A recent article in the Washington Post, Big Cranberry Juice: We can stop UTIs. Science: Maybe.,  reminds us of the Constitutional balancing act that FDA must perform upon finding that a proposed health claim does not meet the Agency’s “Significant Scientific Agreement” (SSA) standard for a health claim and when the proponent remains confident in the research.  The article focuses on marketing concerns as the underlying basis for the potential qualified health claim and discusses critics’ arguments that any type of health claim would be misleading.  The First Amendment, however, requires FDA to permit health claims that are supported by adequate scientific evidence if the use of disclaimers would remove the possibility that the claims may otherwise be misleading.
  • Decisions by the Federal District Court for the District of Columbia in Pearson, et al. v. Shalala, et al. 164 F.3d 650 (D.C. Cir.1999) and Alliance for Natural Health v. Sebelius (2010 WL 2110071) make clear that commercial speech enjoys the broad protections of the First Amendment and may limit FDA’s ability to restrict the language used to qualify Ocean Spray’s health claim.  The petition for a qualified health claim for the consumption of cranberry products and the reduction in risk of recurrent UTIs in healthy women is open for comment until April 23, 2018.  FDA will render a final decision by October 5, 2018.

Codex Alimentarius Committee on Food Additives to be held on March 23-30, 2018, Xiamen, China (50th session)

  • The Codex Alimentarius (Codex al.) is a collection of standards, guidelines, codes of good practices and recommendations adopted by the Codex Alimentarius Commission (CAC). The CAC is the central part of the joint FAO/WHO program setting international food standards recognized in country trade disputes.  The Codex Committee on Food Additives (CCFA) is tasked with setting maximum levels, specifications,  functional classes and unique identification number for individual food additives, and is also assigning a priority list of food additives subject to safety evaluation and establishment of specifications (all being part of risk assessment) by JECFA, the Joint FAO/WHO expert meeting on food additives.
  • Among other topics, the CCFA 50th session is expected to:
    • make significant progress in reducing the backlog on food additives other than sweeteners and colors for a large number of food categories;
    • consider ways to reduce the time between the review by JECFA and subsequent consideration of draft maximum levels by CCFA;
    • take other decisions to amend the list of Codex approved JECFA specifications and amend the international numbering system; and,
    • discuss future strategies and how CCFA may address the pending draft provisions for sweeteners and colors in all food categories, while avoiding the same traps than in the past about reference to national and or regional competent authorities placed in a note used on some, but not all, pending provisions (i.e. the so-called Note 161 issue).
  • This meeting is sure to be of great interest to any food manufacturer marketing internationally.
  • Keller and Heckman has published articles regarding this meeting as well as on the Codex Committee on Contaminants and Toxins meeting in the World Food Regulation Review, Vol. 27, Number 9, February 2018 issue (

For additional questions regarding Codex alimentarius and the regulation of food additives, Keller and Heckman clients may contact Katia Merten-Lentz,, Christophe Lepretre, co-authors of the articles, in Keller and Heckman’s Brussels office, or Mel Drozen,, in the U.S. office.

Court Grants Injunction in Proposition 65 Glyphosate Warning Case

  • A California court has granted an injunction enjoining various growers associations from providing Proposition 65 cancer warnings for crops grown with glyphosate.  In a motion for preliminary injunction, National Association of Wheat Growers et al. v. Zeise, the court held that a Proposition 65 warning conveying that glyphosate causes cancer would not be “factually accurate” and would be “misleading to the ordinary consumer” because almost all other regulators (i.e., apart from California’s Office of Environmental Health Hazard Assessment (OEHHA)) “have concluded that there is insufficient evidence that glyphosate causes cancer.”
  • Glyphosate was listed on Proposition 65 in July 2017, and enforcement of the warning requirement would begin in July 2018.  For more on upcoming changes to Proposition 65 “clear and reasonable” warning requirements, see
  • The decision may be a useful precedent in the event that other companies and organizations decide to push back on Proposition 65 warnings based on arguably inadequate evidence of carcinogenicity or reproductive toxicity.

Additional SNAP Requirements Endanger the Future of the Farm Bill

  • House Agriculture Committee Chairman Michael Conway has delayed the release of a draft law renewing farm and nutrition programs due to opposition to cuts to the Supplemental Nutrition Assistance Program (SNAP), also colloquially known as the “Food Stamps” Program. SNAP offers nutrition assistance to more than 47 million eligible, low-income individuals and families, and is authorized and subsidized by the Farm Bill. The bill, the cost of which has topped $100 billion in previous years, authorizes programs overseen by the USDA, ranging from payments to farmers to funds to prevent forest fires. The current Farm Bill ends September 30.
  • The draft SNAP proposal would expand the number of adults — including able-bodied adults without dependents, known as ABAWDs — who are subject to work requirements. In part, this would be done by raising the work requirement to age 65. ABAWDs aged 18-49 can now receive food stamps for three months as long as they work or are in an employment and training program. Under the proposal, they would have to meet work requirements until age 65.
  • Proponents of the current draft state the money saved as a result of the additional work requirements would be invested in SNAP education and training programs, whereas opponents argue the proposed changes would result in the loss of 8 million people from SNAP. The food industry, of course, has a vested interest in how this all transpires and would likely coalesce to oppose any legislative or policy initiatives that would have the effect of curtailing SNAP eligibility.

USDA Withdraws Organic Livestock and Poultry Practice (OLPP) Final Rule

  • As previously reported on this blog, USDA published the Organic Livestock and Poultry Practices (OLPP) final rule on January 19, 2017. The rule established minimum indoor and outdoor space requirements for chickens based on the type of production and stage of life, as well as added new provisions for livestock handling and transport for slaughter. Initially, the effective date for the rule was March 20, 2017; however, after USDA delayed the effective date several times, the rule was scheduled to become effective on May 14, 2018.
  • On December 18, 2017, USDA announced that it intended to withdraw the OLPP final rule (see our blog post from that day for more details). USDA received approximately 72,000 comments on its proposal to withdraw the final rule. The majority of the comments (over 63,000, including 56,000 form letters) opposed withdrawing the final rule. However, USDA explained in a March 12, 2018 press release that it “has determined that the rule exceeds the Department’s statutory authority, and that the changes to the existing organic regulations could have a negative effect on voluntary participation in the National Organic Program, including real costs for producers and consumers.”
  • USDA published the final rule that withdraws the OLPP rule (82 FR 7042) in the Federal Register on March 13, 2018 (83 FR 10775).  The withdrawal of the OLPP rule is effective May 13, 2018.

Opposing Views and Uncertain Future for the Philadelphia Soda Tax

15 Months In, Philly Still Plagued With Soda Tax Uncertainties (subscription to Law360 required)

  • As previously covered on this blog, Philadelphia’s 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) was conceived by city leaders as a revenue generating measure to fund local health and education needs. The law was challenged before its effective date (January 1, 2017) on grounds of double taxation in a complaint filed by the American Beverage Association (ABA), retailers, distributors, and consumers (see previous blog coverage here).
  • Now, 15 months post-enactment, legal uncertainties remain, with ABA’s case to overturn the 1.5-cent-per-ounce tax accepted on appeal on January 30, 2018 by the Pennsylvania Supreme Court. Under Mayor Jim Kenney’s new five-year plan released March 1, 2018, programs would be expanded in fiscal year 2020, when officials expect the litigation will be over.
  • Opponents argue that consistently soft revenue (15% less than estimated in the first 12 months) and scaled back funding for promised government programs indicate the unpopular tax is a huge policy failure. In contrast, the mayor’s office touts the soda tax as a success, stating that $79 million in revenue is within the margin of error and pointing to programs that have already benefitted.
  • Both sides view the political and legal uncertainties of the soda tax in Philadelphia as a cautionary tale for other cities that may be considering a sweetened beverage tax. Philadelphia warns of well-funded and organized opponents.  Critics of the tax argue it is not an effective or reliable way to fund programs.