• 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.”
  • On January 10, 2022, FDA announced in a letter of enforcement discretion a new qualified health claim for magnesium and reduced risk of high blood pressure.
  • Both health claims and qualified health claims characterize the relationship between a substance and a reduction in risk of contracting a particular disease or health related condition and are reviewed by FDA through a petition process. Qualified health claims are supported by less evidence than the “significant scientific agreement” standard that governs unqualified health claims. Therefore, qualified health claims require a disclaimer or other qualifying language to avoid misleading consumers as to the strength of the scientific evidence supporting the claim.
  • FDA found some credible but inconclusive evidence suggesting a relationship between the intake of elemental magnesium from conventional foods and dietary supplements and reduced risk of high blood pressure. Accordingly, the Agency will exercise its enforcement discretion for the following qualified health claims for conventional foods and dietary supplements:
    • “Inconsistent and inconclusive scientific evidence suggests that diets with adequate magnesium may reduce the risk of high blood pressure (hypertension), a condition associated with many factors.”
    • “Consuming diets with adequate magnesium may reduce the risk of high blood pressure (hypertension). However, the FDA has concluded that the evidence is inconsistent and inconclusive.”
    • “Some scientific evidence suggests that diets with adequate magnesium may reduce the risk of high blood pressure (hypertension), a condition associated with many factors. The FDA has concluded that the scientific evidence supporting this claim is inconsistent and not conclusive.”
  • Foods and dietary supplements making these claims must be “high” in magnesium as defined in 21 CFR 101.54(b) (i.e., must contain at least 84 mg of magnesium per RACC) and must meet all the other general requirements regarding health claims set forth in 21 CFR 101.14, except that tree nuts are exempt from the disqualifying level for total fat provided that the label bears the disclosure “see nutrition information for fat content.” Furthermore, dietary supplements bearing these claims should not provide more than 350 mg magnesium when used according to their labeling instructions. For more information regarding qualified health claims, see FDA’s guidance page.

 SC Johnson Sued Over Ziploc’s Food Preservation Claims (subscription to Law360 required)

  • A putative class action complaint was filed in the U.S. District Court for the Northern District of Illinois on January 2, 2022 against S.C. Johnson & Son Inc., the maker of Ziploc® storage bags.  The plaintiff alleges that consumers understand certain “technology” claims regarding “unbeatable” food protection and preservation on the front labels of various Ziploc® products to mean that the plastic storage bags have advanced qualities which allow unique benefits but are false and misleading because other products provide similar food protection.
  • The complaint involves two claims, “Power Shield Technology – Unbeatable Protection” and “Grip’n Seal Technology – Unbeatable Freshness,” which appear prominently on the front packaging, along with pictures of strawberries in slider bags and seal top bags, respectively.  Packages bearing the protection claim also contain the words STRONGER* THAN HEFTY” in smaller, bold red font and “ON PUNCTURES & TEARS” in smaller black text, in the upper right corner of the package.  The complaint characterizes the “stronger” wording as a separate claim, rather than a qualifying statement, alleging that the product is purported to offer superior protection that is not limited to resistance against punctures or tears.  Regarding the “freshness” claim, the complaint alleges that a moisture loss test involving sliced bread is not relevant and/or is of limited applicability to consumer usage of the products with various foods having a range of spoilage criteria and that Ziploc® bags in any event are not superior to competitor products with respect to moisture loss.
  • Plaintiffs have not provided any extrinsic evidence of consumer deception (e.g., market studies) to demonstrate that “unbeatable protection” or “unbeatable freshness” are reasonably interpreted as described in the complaint.  Keller and Heckman will continue to monitor and report on the outcome of the Ziploc® lawsuit as well as other labeling claim challenges, if any, to other food-related consumer products.

 

  • In a recent article published by the American College of Allergy, Asthma and Immunology (ACAAI), the authors argued that foods containing sesame should be clearly labeled as containing the potential allergen, rather than waiting for the January 2023 effective date of the amended allergen disclosure law. According to the article, more than 56% of products reviewed contained sesame, but the products did not declare the allergen on the label.
  • The most common cause reported for an allergic reaction was through accidental ingestion due to unclear labeling, which is why ACAAI believes that prompt labeling is needed. On the basis of its research, ACAAI concluded that accidental allergic reactions occur at a higher rate due to the lack of product labeling and consumer confusion. For example, ACAAI researchers found that consumers who had an allergic reaction to sesame purchased products with “tahini” or “natural flavors” or “spices” but were unaware that the products contained sesame.
  • Pursuant to the Food Allergy Safety Treatment, Education and Research (FASTER) Act, sesame was added to the list of major food allergens that must be disclosed on a food label.  The effective date of the requirement to declare sesame is January 1, 2023. ACAAI urges food manufacturers to promptly label products with a clear and specific sesame allergen declaration to prevent future accidental adverse allergic reactions to sesame, including anaphylaxis.
  • Keller and Heckman will continue to monitor and report on any sesame allergen labeling developments.
  • On January 5, 2022, FDA published an interactive public data dashboard that will allow anyone to view historical data from the Reportable Food Registry (RFR).  The RFR is a tool that the food industry uses to alert FDA of dangerous food products.  FDA has stated that this dashboard will be a more efficient and less resource intensive process for the agency to provide data to the public.
  • The RFR dashboard includes over 10 years of data, covers 28 commodities, and addresses 20 food safety hazards. Unlike the past RFR annual reports, the new dashboard allows users to interact with the data to get customized information on specific trends, commodities, hazards, and time frames.
  • FDA has also announced that the agency will begin a project in 2022 to allow companies to export the RFR data from their business systems directly to the portal.  Once complete, companies will be able to upload RFR reports to the Safety Reporting Portal, where product safety issues are reported to FDA.  The information will then be distributed simultaneously to both the RFR and Recalls Programs.  FDA anticipates that this update will become available in 2023.
  • The World Customs Organization amended the Harmonized System (HS) Code structure, which is used worldwide for the uniform classification of goods traded internationally. The HS serves as the basis for Customs tariffs and for the compilation of international trade statistics in 211 economies. Although the HS is not an exhaustive list of products, it is an extensive product nomenclature comprised of more than 5,000 commodity groups, ranging from non-manufactured goods, such as animal, vegetable, and mineral products, to manufactured and other highly processed goods.
  • The new HS 2022 edition includes major changes to the Harmonized System with a total of 351 sets of amendments covering a wide range of goods. Key factors driving the amendments include:
    • Advances in technology;
    • New product streams;
    • Changing trade patterns;
    • Environmental considerations;
    • Health and safety considerations;
    • The fight against terrorism; and
    • Facilitating implementation of various international Conventions.
  • HS 2022 is the seventh edition of the HS and entered into force on January 1, 2022. Notably, on December 23, 2021, President Biden issued a proclamation to modify the US Harmonized Tariff Schedule of the United States to conform to the amendments made to the HS. Similarly, the Canadian government has stated that their import requirements must mirror the HS amendments.
  • Last year several food organizations, including the Center for Food Safety and Natural Grocers among others, filed a motion for summary judgment seeking to invalidate USDA’s national bioengineered (BE) food disclosure standard (the “Standard”) on the grounds that it is unconstitutional and inconsistent with its authorizing statute, the National Bioengineered Food Disclosure Act (the Disclosure Act).
  • By way of background, the mandatory compliance date for the Standard was January 1st of this year, and without any court ruling on the merits of the case, all regulated entities are expected to comply with the Standard.
  • Plaintiffs challenge the Standard in part on the following grounds:
    • The Standard exempts highly processed foods which contain no detectable BE material. Plaintiffs argue that such foods can and likely will contain BE material and that the exemption is contrary to the Disclosure Act’s mandate to implement regulations covering disclosure of “any bioengineered food and any food that may be bioengineered” (emphasis added). They also argue that the exemption, which does not mandate the use of any particular technologies, creates a shifting standard and serves as a disincentive for food companies to develop and to use more sensitive technologies. Further, they argue that consumers want to know whether the food they are eating is part of the BE crop system (e.g., because of potential environmental impacts) and are not focused on whether BE material can be detected in the food.
    • The Standard mandates the term “bioengineered,” and disallows use of words such as “genetically engineered” and GMO, which Plaintiffs argue are terms better understood by consumers and widely used by a variety of stakeholders, including consumers, industry, and government agencies, including USDA itself.
    • Plaintiffs argue that USDA’s own study demonstrated that the QR code disclosure option fails to provide many consumers with a feasible means to access information and therefore the standalone QR code disclosure option runs afoul of the Disclosure Act.
    • Finally, the motion argues that the Standard is unconstitutional for a variety of reasons, including that it prevents truthful and not misleading commercial speech (e.g., through prohibition of use of the word GMO).
  • We will continue to monitor and report on this case and other developments that could impact BE labeling.
  • Histamine and other spoilage compounds can form when certain fish species, such as tuna and mahi-mahi, are not chilled promptly after death and maintained in a chilled state, or otherwise treated or processed to prevent microbial activity.  Histamine cannot reliably be removed by washing, freezing, or heating.  As discussed in a recent recall of frozen tuna steak, histamine can produce an allergic reaction called scombroid fish poisoning with symptoms, including a tingling or burning sensation in the mouth, facial swelling, rash, hives and itchy skin, nausea, vomiting or diarrhea, that can appear within minutes to several hours after eating affected fish.
  • On December 27, 2021, FDA published notice of the availability of a draft Compliance Policy Guide (CPG), titled “Sec. 540.525 Scombrotoxin (Histamine)-forming Fish and Fishery Products—Decomposition and Histamine (CPG 7108.24),” which would update and replace existing guidance for FDA staff on adulteration associated with decomposition and histamine identified during surveillance sampling and testing of fish and fishery products susceptible to scombrotoxin (histamine) formation.  The draft CPG would revise two guidance levels for the presence of histamine in these fish as follows:
    • If samples have 35 parts per million (ppm) or more histamine (lowered from 50 ppm), FDA may consider the fish to be adulterated because they are decomposed and/or produced under insanitary conditions.
    • If samples have 200 ppm or more histamine (lowered from 500 ppm), FDA may consider the fish to be adulterated based on the presence of a deleterious substance (histamine) which may render them injurious to human health.

The CPG notes that elevated histamine levels can be prevented in fish by adherence to Current Good Manufacturing Practices and Hazard Analysis Critical Control Point (HACCP) principles required by FDA’s Fish and Fishery Products regulation.

  • FDA has requested feedback on the draft CPG (docket number FDA-2021-D-0367).  The comment period will be open for 60 days, until February 25, 2022.
  • In a December 21 Constituent Update, the FDA announced that they provided the General Administration of Customs of China (GACC) lists of U.S. establishments that sought to be recommended for registration in China via the FDA’s Export Listing Module (ELM). We have previously blogged about the GACC’s registration requirements applicable to all foreign food companies that manufacture, store, or process food exported to China. See our October 25 and December 7 posts for further detail.
  • The FDA has requested that the GACC promptly register these establishments so they can continue to export their goods after January 1, 2022, when the applicable regulations (Decree 248 – Regulations on Registration and Administration of Overseas Manufacturers of Imported Food) will take effect.
  • The Constituent Update noted that the “U.S. government continues to engage with Chinese officials to express concern about the nature of the requirements and gain clarity about how China will apply the new requirements to U.S. products.” Specifically, the U.S. is asking for confirmation that competent authority recommendation is not a requirement for U.S. facilities to register with China. And given the lack of clarity, the U.S. is urging China to delay the implementation of the Decrees by a minimum of 18 months.
  • Keller and Heckman will continue to monitor and report on any updates regarding the new registration requirements in China.