• On January 26, 2022, FDA published a constituent update reminding produce stakeholders about FDA’s intention to exercise enforcement discretion for agriculture water requirements for covered produce, except for those related to sprouts, which are subject to unique requirements.  The agricultural water regulations apply to farms subject to the Food Safety Modernization Act (FSMA) Produce Safety Rules.
  • As previously reported, the enforcement discretion was initially announced in a proposed rule on agricultural water in which FDA proposed to replace pre-harvest microbial quality criteria and testing requirements with new system-based pre-harvest agricultural water assessments.
  • In the proposed rule, FDA acknowledged that current agricultural water compliance dates are set to begin in January 2022 and that, in turn, the agency intends to exercise enforcement discretion for covered produce (except sprouts). FDA will work to complete compliance date rulemaking as soon as possible. In the meantime, FDA reminds covered farms that they should continue implementing good agricultural practices to maintain the quality of their water sources.
  • On January 24, Judge James P. Arguelles for the Superior Court in Sacramento County ordered an enforcement delay of a part of California’s Proposition 12. Judge Arguelles ruled that grocers, restaurants, and retailers would not be subject to enforcement of the new restrictions on whole pork meat sales until six months after the state enacts final regulations. The ruling comes in response to a January 21 hearing for a prohibitory writ of mandate and complaint for declaratory and injunctive relief, petitioned by the California Hispanic Chambers of Commerce, Kruse & Son, Inc., California Grocers Association, California Restaurant Association, and the California Retailers Association.
  • As a recap from our 2019 blog post on Prop 12, California voters passed this law as a ballot initiative in the November 2018 election. The new law established the standard for confinement of certain farm animals and bans the sale of eggs, veal, and pork products that do not comply with the new confinement standards. In 2019 and 2020, the California Department of Food and Agriculture (CDFA) solicited input from stakeholders regarding the regulatory framework for Prop 12, with specific focus on production facility registration, certification, verification audits or inspections, border station inspections, and a penalty matrix for violations including an appeal process. In May 2021, CDFA and the California Department of Public Health (CDPH) published proposed regulations, which triggered a 45-day public comment period. The revised proposed regulations were published on December 3, 2021 and had a 15-day comment period. Final regulations are not yet in effect, but some grocery store chains and pork suppliers have issued statements of compliance with the Act while awaiting the final regulations.
  • However, the petitioners in the instant proceeding argued that, without final regulations, they should not be subject to penalties associated with sales of nonconforming whole pork meat. Petitioners asked the court to (1) declare the square-footage requirement unenforceable absent final regulations, (2) delay enforcement of the same requirements until 28 months post-publication of final regulations, and (3) bar the CDFA and CDPH from enforcing the square-footage requirements for 28 months post publication.
  • In the order, Judge Arguelles held that, because the Act required the promulgation of final regulations by September 1, 2019, a delay in enforcement was warranted but disagreed that a 28 month delay was appropriate because “[t]he court must be mindful of the Act’s concern about cruel confinements, and the enforcement delay must not exceed a period that is necessary. Thus, he ordered the court’s writ to remain in effect until 6 months post-publication of the final regulations.
  • A class-action lawsuit filed at the end of last year alleged that Non GMO (genetically modified organism) claims on many of Gerber’s baby food products are false and misleading because the products contain ingredients derived from genetically modified crops and protein and/or dairy sources derived from cows raised on genetically modified feed.
  • The lawsuit alleges that Non GMO and similar claims (e.g., GMO free) are understood by consumers in a manner consistent with the definitions set forth by the Non GMO Project, a non-profit organization that offers a “Non GMO Project” certification which requires that the certified foods contain no genetically modified processes or inputs (e.g., animal food products derived from animals fed genetically engineered feed). Plaintiff credits the widespread use of the Non GMO Project label and the educational outreach efforts of the organization with aligning consumer expectations with the Non GMO Project Standard.
  • The case presents interesting issues because “Non GMO” has no defined regulatory meaning. Disclosure of the presence of genetically modified material in foods is regulated by USDA’s National Bioengineered Food Disclosure Standard (BE Standard), which mandates labeling of food that contains bioengineered material (the BE Standard uses the term “bioengineered” instead of GMO). However, claims regarding the absence of genetically modified material are regulated by FDA and, while FDA has issued a guidance document regarding these voluntary absence of genetically modified material claims, the document does not define what it means to be “Non GMO.” In fact, the Guidance discourages (but does not prohibit) the use of the term GMO in favor of terms such as genetically engineered and further recommends against the use of “Non GMO” and similar claims because of the potential substantiation challenges.
  • Compounding the difficulty of determining the meaning of Non GMO is the fact that the absence of a required bioengineered disclosure (under the BE Standard) does not mean that a food is necessarily “Non GMO.” For example, as at issue here, a food sourced from animals fed genetically modified/GMO feed is not required to be labeled as bioengineered under the BE Standard, but it would not meet the Non GMO Project’s definition of Non GMO. For our reporting on a legal challenge to the BE Standard, see our prior post.
  • We will monitor and report on this case and any other developments on the meaning of Non GMO and similar claims.
  •  Consumer class action lawsuits against Goldfish-brand snacks (discussed here) and others have alleged that such products do not comply with 21 CFR § 101.60 (“Nutrient content claims for the calorie content of foods”) because the products claim “0g Sugars” or “0g Total Sugars” (i.e., sugar free claims) without disclosing that they are “not a low calorie food,” “not a reduced calorie food,” or “not for weight control.”  While Section 101.60 does not reference quantitative claims, plaintiffs assert that “0g Sugars” and “0g Total Sugars” are substantively identical to the claims “sugar free,” “free of sugar,” and other claims delineated in the regulation that require such a disclaimer.
  • In a recently updated Q&A segment under “Label Claims” on its website: Industry Resources on the Changes to the Nutrition Facts Label, FDA clarified that the additional statements required when making the sugar content claims defined in Section 101.60(c) are not required for quantitative claims about sugar.  Specifically, FDA stated:

Title 21 CFR 101.60(c) discusses certain sugar content claims and the specific conditions for their use, including the conditions for requiring the accompanying statements “not a reduced calorie food,” “not a low calorie food,” or “not for weight control.” Statements about the amount of the nutrient in a food, which would include “0 g total sugars,” are provided for in 21 CFR 101.13(i), which discusses the specific conditions for their use. Although amount statements are nutrient content claims and would, therefore, have to follow the general requirements for nutrient content claims, amount statements need not follow the requirements provided for specific, individual nutrient content claims as described in Subpart D of 21 CFR 101 (21 CFR 101.54 – 101.67). As such, 21 CFR 101.60(c) does not require “0 g total sugars” amount statements to be accompanied by the additional statements.

  • FDA’s clarification resolves an important point of contention in recent consumer class actions and in our view would be equally applicable to any quantitative claim made.
  • On January 14, 2022, FDA released a report on the investigation into the Summer 2021 outbreak of Salmonella Typhimurium associated with the consumption of packaged leafy greens. The investigation found that the outbreak was linked to leafy greens produced at a Controlled Environment Agriculture (CEA) indoor hydroponic operation.
  • In July and August of 2021, FDA, CDC, and state partners conducted an outbreak investigation into the leafy green outbreak. The investigation consisted of interviews with key personnel, observation of operations, the collection of samples, and environmental swabs throughout the operation. FDA was not able to identify the specific source of the contamination; however, the agency identified various practices that could result in contamination, such as contaminated pond water used to grow the leafy greens, growth media storage practices, water management practices, and general sanitation practices.
  • FDA notes that—while CEA, such as hydroponics, may differ in many ways from open field growing—many contamination risk factors are similar to those found in traditional agriculture. FDA has highlighted various requirements and recommendations for such operations, including:
    • Understanding potential sources of contamination and implementing effective sanitation procedures and sampling plans
    • Ensuring the implementation of appropriate preventative measures, including provisions of FDA’s Food Safety Modernization Act Produce Safety Rule and good agricultural practices
    • Performing a root cause analysis when a pathogen is identified in the growing environment to determine how the contamination occurred and implement appropriate prevention measures
    • Assessing and mitigating risks that may be associated with nearby land uses and may impact operations
  • FDA’s report is intended to prevent future outbreaks at similar operations by highlighting the factors determined to have contributed to the outbreak, which led to 31 illnesses across four states.

 

  • On January 13, the FDA published the Interagency Working Group on Asbestos in Consumer Products (IWGACP) white paper, “IWGACP Scientific Opinions on Testing Methods for Asbestos in Cosmetic Products Containing Talc (including Talc Intended for Use in Cosmetics).” Following a February 2020 public meeting on asbestos testing, the IWGACP was asked to develop a consensus document that would support the development of standardized testing methods to improve the sensitivity and consistency of analyses and inter-laboratory concurrence when reporting asbestos and other similar particles in talc that could potentially affect cosmetic product safety.
  • The IWGACP was formed by the FDA and consisted of subject matter experts from 8 US federal agencies: FDA, NIOSH, NIH, NIEHS, OSHA, EPA, CPSC, and USGS. The agencies have expertise in asbestos-testing and/or asbestos related issues (e.g., from a health perspective), or because they regulate some of the consumer products that contain talc as an ingredient.
  • The IWGACP white paper outlines scientific opinions on the testing of talc-containing cosmetic products that are intended to inform FDA’s consideration of testing methods and development of policy recommendations. As outlined in the FDA’s constituent update, the IWGACP’s scientific opinions include:
    • Utilizing both Polarized Light Microscopy (PLM) and Transmission Electron Microscopy (TEM) methods to identify and report the presence of asbestos and other similar particles;
    • Reporting all asbestos and other similar particles greater than or equal to (≥) 0.5 µm in length with a length to width aspect ratio (AR) ≥ 3:1;
    • Providing analytical reports with adequate documentation of findings;
    • Establishing policies and procedures covering rigorous training, quality assurance, and quality control, to accompany testing methods, to ensure testing laboratories are qualified and their qualifications are reviewed on a regular basis; and
    • Encouraging future research on reference materials and sample preparation methods to support standardized test methods for the detection of asbestos in talc and talc-containing cosmetics.
  • The white paper and its technical appendices are to undergo an external peer review in 2022.
  • On January 14, 2022, the FDA and the National Egg Regulatory Officials (NERO) announced the Egg Regulatory Program Standards (ERPS), a program which provides state regulators of egg and egg products with best practices for the implementation of their egg and egg-product regulatory programs.
  • By way of background, regulation of eggs and egg products is handled by FDA, USDA, as well as state regulators. At the federal level, FDA regulates shell eggs while USDA regulates egg products. However, many states conduct egg inspections under the authority of state laws and regulations and/or the Federal Food, Drug, and Cosmetic Act, including egg inspections contracted out by FDA to the states. ERPS is intended to encourage uniformity in this complex regulatory landscape and to provide a model system that best protects the public health.
  • ERPS consists of the following 10 standards that establish requirements for a model state regulatory program which will protect the public from outbreaks of food-borne illness in egg and egg products:
    1. Regulatory Foundation – evaluation of the state program’s regulatory authority;
    2. Staff Training – written training plans and continuing education;
    3. Inspection – written safety inspection and sampling procedures;
    4. Quality Assurance – written procedures to audit the effectiveness of inspection and sampling;
    5. Egg and Egg Product-related Incident Response – written procedures to respond to contamination or adulteration of egg or egg product incidents;
    6. Enforcement – a documented enforcement program;
    7. Industry Outreach – outreach and communication to stakeholders;
    8. Resource Management – assessment of the resource needs of the program;
    9. Program Assessment – periodic reassessment of the regulatory program against the criteria established by ERPS; and
    10. Laboratory Support – adequate access to labs to support the program.
  • Implementation of ERPS is voluntary and currently only California and Iowa are enrolled; both these states were involved in the development of ERPS.
  • Earlier this month, The City of New York Council passed INT-1326B, The Sweet Truth Act, a local law to amend the New York City(NYC) administrative code. This bill provides the NYC Department of Health and Mental Hygiene with the authority to issue a rule that requires added sugar notifications on certain prepackaged food items at NYC covered establishments. A prepackaged food item is defined as a prepackaged food item that is visible to the customer before the customer makes a selection. A covered establishment includes any food service establishment inspected pursuant to the NYC health code restaurant grading that is part of a chain with 15 or more locations that are doing business under the same name and offering for sale substantially the same food items.
  • To implement the law, the department must issue a regulation that designates an icon to be displayed in a clear and conspicuous manner on menus and menu boards adjacent to listed prepackaged food items that contain in excess of a specified level of added sugar, as well as on any displayed prepackaged items themselves.  The law did not define the level of added sugar triggering the notice requirement, but noted that it could include, but not be limited to 100% of the daily recommended amount for added sugars.
  • No later than three months after the department issues the regulation, the department will conduct public outreach to educate covered establishments about the requirements of The Sweet Truth Act. Covered establishments selling prepackaged food items must comply no later than one year after the department issues the regulation.  Any covered establishment that violates any provision of this section will be liable for a civil penalty of not less than $200 but not more than $500.  The local law is schedule to take effect, “no later than one year after the expiration of the declaration of the local state of emergency for COVID-19 declared in emergency executive order number 98 of Mayor Bill de Blasio, dated March 12, 2020, including any subsequent extensions.”
  • Keller and Heckman will continue to monitor and report on similar labeling developments.

 

  • As previously reported, on December 21, 2020, FDA issued a proposed rule to revoke the standard of identity (SOI) for French dressing. The standard of identity for French dressing, codified at 21 C.F.R 169.115 (“French dressing”), was established in 1950 and amended in 1973. The proposed rule was issued, in part, as a response to a citizen petition filed by the Association for Dressing and Sauces arguing that the standard is outdated.
  • On January 12, 2022, FDA announced that it is finalizing the rule to revoke the SOI for French dressing. FDA has concluded that revocation of the standard will allow for more flexibility and greater innovation of products.  In its final rule, FDA notes that consumers have come to expect a French dressing that no longer conforms to the regulation. Rather, consumers expect French dressing products to contain tomato ingredients, as well as have a characteristic red color and sweet taste.  In addition, French dressing products are offered in lower-fat varieties and may contain less vegetable oil than the minimum amount established by the SOI.  Thus, FDA has concluded that the SOI no longer promotes honesty and fair dealing in the interest of consumers.
  • This final rule marks the first standard of identity-related final rulemaking in 2022 on FDA’s regulatory agenda, which also includes revocation of the frozen cherry pie standard of identity.

 

  • On January 11, the FDA released an updated version of the “Procedures for Standardization of Retail Food Safety Inspection Officers,” which is one of the Agency’s means to reduce and prevent foodborne illnesses. The Procedures provide regulatory personnel the process and criteria for demonstrating proficiency in required performance areas. The FDA also released an updated “Standardization Field Workbook.”
  • The Procedures are based on the FDA Food Code and are updated to reflect current Food Code provisions, as well as include more focus on foodborne illness risk factors, Food Code interventions, and application of the Principals of Hazard Analysis Critical Control Point (HACCP). Updates to the Procedures include:
    • Extending the time for completing at least 20 contact hours of training for re-standardization from 2 years to 3 years (Chapter 2);
    • Clarifying job responsibility for conducting retail food safety standardization of other regulatory personnel within the eligibility requirement (Chapter 3);
    • Highlighting food safety-related activities as the focus for meeting the Continuing Education and Training requirements (Chapter 3)
    • Updating Standardization Suspension and Revocation section to make allowance for special circumstances (Chapter 3), and
    • Replacing the Risk Control Plan example with a new example that utilizes a root cause analysis approach (Annex 3-2)
  • As stated in the notice of publication, the FDA believes that “[i]t is critical that food safety personnel become Standardized through this process to ensure that retail foods are safe, unadulterated, and honestly presented at retail throughout the United States. A certificate of standardization as an FDA standardized food safety inspection officer is issued to all Candidates who successfully complete the standardization process.”