FDA Issues Draft Guidance on “Small Business” under FSMA Preventive Controls Regulations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  • On March 19, 2018, FDA released a draft guidance to assist businesses in determining their size under the Preventive Controls regulations.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 The draft guidance explains terms such as “subsidiary,” “affiliate” and “full-time equivalent employee.”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 (https://www.khlaw.com/Files/35431_wfrr_feb_2018_production.pdf).

For additional questions regarding Codex alimentarius and the regulation of food additives, Keller and Heckman clients may contact Katia Merten-Lentz, mertenlentz@khlaw.com, Christophe Lepretre, lepretre@khlwaw.com co-authors of the articles, in Keller and Heckman’s Brussels office, or Mel Drozen, drozen@khlaw.com, 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 https://www.khlaw.com/9500.
  • 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.

FDA Announces Proposed EU Shellfish Equivalence Determination

  • The United States and the European Union (EU) have not traded live shellfish for nearly eight years. Since 2010, U.S. shellfish imports have not been allowed to enter the EU, and the U.S. Food and Drug Administration (FDA) has not permitted the import of live, fresh or fresh-frozen molluscan shellfish from the EU since the 1980s.
  • On March 8, 2018, the FDA published a proposed determination in the Federal Register, stating that the safety controls for shellfish in the EU are equivalent to those in the U.S.  If the determination becomes final, Massachusetts and Washington state will once more be able to send bivalve molluscan shellfish (shellfish) to the EU. Shellfish exporters from Spain and the Netherlands will also be able to sell shellfish in the U.S. market. FDA notes that the Agency will continue to work with the EU on procedures to add more states and European countries.
  • In a complementary action, the European Commission is completing administrative procedures for its own proposed determination that U.S. safety controls for shellfish are equivalent to those in the EU, a necessary step towards resuming trade.
  • The FDA will be accepting public comments on the Federal Register notice through May 23, 2018.

WHO Names South African Listeria Outbreak World’s Largest

  • According to the UN World Health Organization (WHO), South Africa is currently in the middle of the largest listeria outbreak ever seenAs of this week, the outbreak has sickened almost 1,000, with at least 180 fatalities, and has received extensive press coverage globally (see e.g., here and here).  The cause of the outbreak has been unknown for the past several months.
  • On March 4, 2018, the South African health minister stated that the source of the outbreak was linked to a nationally popular ready-to-eat (RTE) meat product called “polony” manufactured by two unrelated brands. The products are being recalled. Africa’s health ministry is now concerned about the risk of cross-contamination and so has advised members of the public to avoid all processed meat products that are sold as ready-to-eat.
  • This event will inevitably lead the implicated companies to revisit their respective food safety protocols, and could potentially lead regulators in South Africa to consider new approaches to achieving food safety goals with specific regard to RTE meat products.

GAO Report: FDA Can Do More to Achieve Food Safety & Nutrition Goals

  • The Food Safety Modernization Act (FSMA), enacted in January 2011, shifted the FDA’s focus from responding to illnesses to preventing food contamination.  A new report by the U.S. Government Accountability Office, released on March 5, 2018, examines FDA’s actions on food safety since FSMA became effective.
  • The GAO report, titled “FDA Can Build on Existing Efforts to Measure Progress and Implement Key Activities,” notes that since the enactment of FSMA, the FDA has conducted numerous food safety- and nutrition-related activities, including publishing 33 proposed or key final regulations, and 111 draft or final key guidance documents with a focus on food safety.
  • In the report, the GAO calls upon the FDA to implement three recommendations:
    • Direct the Food and Veterinary Medicine (FVM) program staff to uniformly document the basis for their decisions on issuing either regulations or guidance related to food safety and nutrition, such as using concept papers or guidance initiation sheets.
    • Develop FVM program performance measures with associated targets and timeframes for all eight of FDA’s food safety and nutrition-related objectives.
    • Complete an implementation plan including specific actions, priorities and milestones for the FVM program’s strategic plan.
  • The Report notes that the Agency agrees with GAO’s recommendations and has identified actions to implement them.