Search results for: preservative

  • On June 11, 2021, the FDA will issue its final rule to revoke the standards of identity (SOIs) for lowfat and nonfat yogurt, and amend the SOI for yogurt. The final rule regulates lowfat and nonfat yogurts under the general SOI for yogurt at 21 CFR § 131.200 and 21 CFR § 130.10 (“Requirements for foods named by use of a nutrient content claim and a standardized term”).  This action is in response to a citizen petition filed by the National Yogurt Association (NYA) in 2000 and is part of FDA’s Nutrition Innovation Strategy.  FDA states that the final rule modernizes the yogurt standard “by allowing for greater flexibilities and technological advances in yogurt production.”
  • The final rule permits the use of any optional safe and suitable milk-derived ingredient to increase “milk solids not fat content,” as well as safe and suitable emulsifiers, flavors, color additives, preservatives, cultures, stabilizers, and nutritive carbohydrate sweeteners.  FDA decided to retain reference to “nutritive carbohydrate sweeteners” instead of referring to “sweeteners” to exclude nonnutritive sweeteners.  FDA explained that, to comply with FDA’s regulatory framework under the Nutrition Labeling and Education Act (NLEA), nonnutritive sweeteners may only be added to yogurt under § 130.10 with a corresponding nutrient content claim (e.g., “reduced calorie yogurt”).  The final rule also optionally permits fortification with vitamins A (at a minimum of 10% of the daily value per serving) and vitamin D (at a minimum of 25% of the daily value per serving) and within the limits of current good manufacturing practices.
  • The final rule establishes minimum amounts of live and active cultures for yogurt products to bear the optional labeling statement, “contains live and active cultures.” To bear the label, yogurt must contain at least 107 CFU/g of live and active cultures at the time of manufacture and a reasonable expectation of 106 CFU/g throughout the product’s assigned shelf life.  If dairy ingredients are treated after culturing to inactivate viable microorganisms, the final rule requires a statement of “does not contain live and active cultures” on the label (§ 131.200(f)(1)(ii)). The statement must appear in letters not less than one-half of the height of the letters used in the product name.
  • The final rule is effective on July 11, 2021 and has a compliance date of January 1, 2024.

 

  • Meat, poultry, and egg products may not be sold, offered for sale, or otherwise distributed in commerce without prior approval of labels by the U.S. Department of Agriculture’s Food Safety Inspection Service (FSIS).  Prior approval is granted in one of two ways: (1) “Sketch approval,” which entails Agency review of food labels; and (2) “Generic approval,” which is label approval obtained by virtue of the label being in compliance with applicable regulations.  Generic label approval has been in place in some form since 1983.  In a 2013 rulemaking, FSIS expanded the categories of labels eligible for generic approval and agreed to continue evaluating generic labels that are voluntarily submitted.
  • In a new Proposed Rule published in the September 14, 2020 Federal Register, FSIS announced plans to cease evaluating labels voluntarily submitted to FSIS that are eligible for generic approval and to expand the types of labels that are eligible for generic approval.  Under this proposal, the following labels would be eligible for generic approval, would no longer be required to be submitted to FSIS for prior approval, and could no longer be voluntarily submitted to FSIS for evaluation:

(1) Labels on products for export that deviate from FSIS requirements;

(2) labels that list ingredients in the ingredients statement as being certified ‘‘organic’’ (e.g., organic garlic) under the Agricultural Marketing Service (AMS) National Organic Program;

(3) labels that display geographic landmarks, such as a foreign country’s flag, monument, or map;

(4) labels that make ‘‘negative’’ claims identifying the absence of certain ingredients or types of ingredients (e.g., statements such as ‘‘No MSG Added,’’ ‘‘Preservative Free,’’ ‘‘No Milk,’’ ‘‘No Pork,’’ or ‘‘Made Without Soy’’); and

(5) labels of all products that receive voluntary FSIS inspection (e.g., rabbits; elk, bison, and migratory water fowl; and closed-faced sandwiches), some of which are not covered under the Agency’s current generic approval regulations.

  • FSIS has opened a 60-day period (ending November 13, 2020) for submitting comments on the proposed rule.  In addition to fully adopting the proposed rule, FSIS will also consider either taking no action, or adopting the proposed rule in part by continuing to provide industry the option to have FSIS evaluate labels that would otherwise be generically approved.  FSIS will also consider the alternative of having all labels to be generically approved.  No timeline was provided for promulgating a final rule with associated dates for compliance and enforcement actions.
  • Notably, FSIS states it does not believe this new proposal for expanding eligibility for generic approval and discontinuing evaluation of voluntarily submitted labels that are eligible for generic approval is affected by any of the findings of a June 2020 Audit Report by the Office of Inspector General (OIG) on Controls Over Meat, Poultry, and Egg Product Labels or FSIS’s responses to these findings.  OIG’s June 2020 report includes a finding, disputed by FSIS, of reduced assurance that establishments’ generic labels used in commerce meet requirements because FSIS does not have an adequate process to determine whether establishments’ generic labels meet requirements.
  • On July 16, the Japanese Consumer Affairs Agency (CAA) announced a revision to the Food Labeling Standards (“Standards”) of Japan under which sweeteners, colors and preservatives are no longer allowed to be supplemented with words such as “artificial” and “synthetic” when they are declared by their function names with substance name on the food label. In the meantime, food flavorings can only be collectively declared as “flavors” without further specification as to whether or not they are “artificial” (a table comparing the new rule and the existing rule is available here).
  • According to CAA’s Report on the Review Meeting of Food Additive Display Mechanism (“Report”) which was held on March 31, 2020, the above revision is based on a consumer survey result that shows consumers are more likely to avoid a food product when its label suggests use of artificial food additives, even though use of all food additives declared thereon have been evaluated and cleared by the Japanese food authority. Accordingly, CAA proposed not to distinguish the abovementioned types of artificial food additives from natural food additives in food labeling.  It is worth noting that, under the current Standards, “natural” and similar words cannot be used in the labeling of food additives.
  • The industry has until March 31, 2022 to adapt to this policy change.
  • Per the Report, CAA is also considering updating its guideline on the claims of “no additive” and “not used” under the Standards and relevant fair competition rules. The current Standards do not specifically regulate “additive free” type of claims, and thus, cause confusion among consumers when those claims are made on a voluntary basis by food business operators.
  • Keller and Heckman’s Shanghai office monitors food regulatory and labeling developments in Japan and would be happy to answer any questions.
  • On June 3, 2020, the Sugar Association filed a Citizen Petition for Prohibition of Misleading Labeling Sweeteners and Request for Enforcement Action (the “Petition”).  The Petition seeks FDA guidance and enforcement on what the association believes are false and misleading sugar reduction claims.  The association observes that “added sugar” labeling requirements have led food manufacturers to replace sugar with alternative sweeteners.  As a result, the association argues that the reformulated products are not understood by consumers to contain alternative sweeteners and, further, use claims that mislead consumers into believing that the reformulated products are healthier.
  • In order to remedy the alleged misleading claims and lack of transparent labeling, the Petition calls upon the FDA to issue regulatory guidance requiring that food labels:
    1. Clearly identify the presence of each sweetening ingredient in the ingredient list that is not already disclosed on the Nutrition Facts label by providing the term “(Sweetener)” following the sweeting ingredient’s name.
    2. Indicate the type and quantity of alternative sweeteners on the fronts of food and beverage products consumed by children.
    3. Disclose gastrointestinal effects of various sweeteners, including all sugar alcohols, at minimum thresholds of effect.
    4. Accompany any “no/reduced sugar” claims with the following disclosures:
      • “Not lower in calories,” unless the reformulated products have 25% fewer calories than the comparison.
      • “Sweetened with [name of Sweeteners(s)]” when sugar alternatives are present.
  • By regulation, the FDA has 180 days to respond to the Petition but a substantive response can take much longer.  Including functional labeling for food additives is reserved only for a few select categories, such as preservatives.  Thus, the request to identify all sweeteners by their functional class name is a big change that could have an impact on the declaration of other food additives. Keller and Heckman will continue to monitor and report on the progress of this petition and any changes to food labeling regulations.
  • In a March 9 email to stakeholders, Health Canada’s Food Directorate requested data in regard to food additives in certain food flavouring preparations. The Food Directorate is responsible for assessing health risks and benefits, setting standards, policies and regulations, and providing advice and information regarding the safety and nutritional quality of food. In Canada, all permitted food additives and their conditions of use are listed in the Lists of Permitted Food Additives (“Lists”). In its email, the Food Directorate stated that it intends to modify the Lists to specify which coloring agent(s), preservative(s) and emulsifying agent(s) are permitted in flavoring preparations and their maximum levels of use. The agency noted that this would be similar to the listing for the sweetener, thaumatin.
  • In its email, the Food Directorate stated that stakeholder data will ensure that food additives currently in use are considered when the agency modifies the Lists. The Food Directorate requested the following information:  (1) A list of the coloring agents, preservatives and emulsifying agents currently being used in flavoring preparations subject to the compositional standard for (naming the flavor) extract and (naming the flavor) essence or the compositional standard for (naming the flavor) flavor; (2) The purpose for which each food additive is used in the flavoring preparation (this should be explanatory in nature, not simply a reference to the functional class of the additive (g. “antimicrobial effect” for Class II preservative); and (3) The typical and maximum level of use of each food additive in each type of flavoring preparation, expressed as percent by weight if the use level is 1% or greater or parts per million if the use level is less than 1%.
  • The Food Directorate asks that interested stakeholders submit data by May 9, 2020. We will continue to monitor any developments and are happy to help submit data to Health Canada’s Food Directorate.

At the end of 2019, the Chinese State Administration of Market Regulation (SAMR) and the National Health Commission (NHC) proposed significant changes to two food labeling documents for public comments:

Both documents are mandatory for the labeling of prepackaged food produced in and exported to China. It should be noted that the proposed requirements by SAMR and NHC in the drafts do not appear to be fully aligned. For instance, SAMR’s Draft Measures require that a separate item “Food Additive” shall be made available in the ingredient list if the food uses a sweetener, preservative, color, emulsifier, or thickener; however, this is not required under the NHC’s Draft Standard. Therefore, further coordination between SAMR and NHC is expected to eliminate contradictory requirements like this and provide regulatory clarity to the industry.

SAMR and NHC have appeared to tighten certain labeling requirements, particularly ones that have involved past consumer complaints, for example:

  • NHC in the Draft Standard introduces new requirements for “negative claims,” e.g., “free of XXX,” “does not contain XXX,” or words with the similar meaning are prohibited if the substances are not permissible for use by pertaining regulations and standards. The claim “Non-GMO” is another example of a banned claim even if the food does not use any GMO ingredient.
  • SAMR in its Draft Measures proposes different rules of application for labeling information that is mandatorily and required by law versus one that is voluntarily declared by the manufacturer. Specifically, the information on the food package, other than the labeling information mandated by China, is subject to additional requirements set forth in the Advertising Law, Anti-unfair Competition Law and other regulations. For instance, if one wishes to claim on the label that the product is ranked the No. 1 organic milk in China, proper assessment and substantiation of such claim must be done in advance, not only based upon the food labeling legislation, but other applicable rules, e.g., advertising requirements.

Keller and Heckman attorneys have prepared a new China Regulatory Matters (CRMs) newsletter examining further details of the above two Drafts which can be found at Are You Ready for China’s New Food Labeling Requirements? Please stay tuned to the developments of the food labeling requirements in China by subscribing to our CRMs.

A leading poultry producer has been sued over “natural” claims on its chicken products.  (subscription to Law360 required)

  • Americans’ increasing appetite for clean label, ethically-raised foods has resulted in the continued proliferation of consumer advocacy litigation targeting “natural” claims for products containing synthetic ingredients or preservatives.  Adding fuel to the continued uptick in “natural” litigation is the fact that neither the U.S. Food and Drug Administration (FDA)  nor the U.S. Department of Agriculture (USDA) formally define the term “natural.” As previously covered on this blog, the FDA is considering whether to regulate the term “natural”.  USDA’s Food Safety & Inspection Service (FSIS), on the other hand – which regulates meat and poultry products – currently has in place an informal policy on “natural” which permits USDA-regulated products to be labeled “natural” when the product does not contain any artificial flavor or flavoring, coloring ingredient, chemical preservative (as defined in 21 C.F.R. 101.22), or any other artificial or synthetic ingredient; the policy also provides that the product and its ingredients cannot be more than minimally processed.  USDA-regulated products bearing “natural” claims must be specifically approved by FSIS before entering commerce.
  • Against this regulatory backdrop, on June 22, 2017, three consumer advocacy groups – the Organic Consumers Association, Friends of the Earth and Center for Food Safety – filed a complaint against Sanderson Farms Inc., the third largest poultry producer in the United States, accusing the company of falsely advertising its chicken as “100 percent natural” and misleading consumers about how the birds are raised by concealing the presence of antibiotics and other drugs in its chickens.  In particular, the complaint – filed in the U.S. District Court for the Northern District of California – alleges that FSIS National Residue Program testing in 2015 and 2016 identified 49 instances in which samples of Sanderson Farms chicken products tested positive for residues of synthetic drugs, including antibiotics used in both humans and animals and other drugs including the anesthetic ketamine.  The complaint also alleges that FSIS testing revealed an additional 82 instances of unconfirmed residues including pesticides.
  • In a statement released on June 23, 2017, Sanderson Farms denied the allegations, stating that it “does not administer the antibiotics, other chemicals and pesticides, or ‘other pharmaceuticals’ listed in the complaint to its flocks”.  The Company added, however, that its “veterinarians do, on rare occasions, prescribe penicillin to treat sick poultry flocks when in their professional judgement they consider it necessary for animal welfare” in line with FDA guidance.
  • This latest lawsuit represents a recent trend in “natural” litigation targeting USDA-regulated products.  As our readership will recall, just last Fall, a class action lawsuit was filed against Hormel Foods Corp. alleging that Hormel includes synthetic ingredients and preservatives in deli meat labeled as “100% Natural” or “No Preservatives”.  Key defenses there included federal preemption and primary jurisdiction.  Assuming the Sanderson Farms products at issue do not run afoul of the current USDA policy on “natural” and the labels themselves were specifically approved by USDA, we would expect Sanderson Farms to avail itself of similar defenses. In addition, because USDA is working to update the definition of “natural”, Sanderson Farms could potentially request a stay on the proceedings pending the issuance of the forthcoming definition as has been successfully done in a number of recent “natural” cases concerning FDA-regulated products, see e.g., here and here (although the difference in this case is that USDA has not yet formally published a document for public comment).
  • Given increasing consumer demand for “natural” products, and the corresponding increasing market share for such products, the ultimate disposition of the ongoing litigation will be of great interest to industry and consumers alike. We will be sure to keep a close eye on developments in this case and report them to you here.

• Attacks on excess sugar in the diet are coming from all directions. On September 1, 2016, we reported that, The American Heart Association Recommends Dramatically Reducing “Added Sugar” Intake; and, last month on this blog, we discussed the number of jurisdiction in the U.S. and abroad that have or are planning to tax sugary products, and the effectiveness of those taxes. Also, in less than two years, on July 26, 2018, manufacturers with $10 million or more in annual food sales will be required to list “added sugars,” in grams and as percent Daily Value on the Nutrition Facts panel of packaged foods and beverages sold in the U.S.

• As attacks on sugar consumption heat up, consumers are taking notice. Recent research by CivicScience found that consumers are more concerned about the amount of sugar in their diet than previously. In response to the question, “Which of these do you feel is most harmful to your nutritional health?” 26% choose “added and total amount of sugar” in 2016, up from 24% in 2015. The only category to have a higher response is “preservatives/chemicals,” although that category decreased from 36% to 33% between 2015 and 2016. CivicScience noted that 15% of adults believe that the total amount of sugar is most harmful, while 12% believe added sugar is the most harmful. Since responses to both categories increased by the same amount, the research company combined the options.

• As a result of the increased concern about sugar in the diet, CivicScience suggested that companies may want to switch the focus from “preservative-free” and “all natural” to terms such as “made from natural sugars” or “no sugar added.” At a minimum, food and beverage manufacturers need to carefully consider the level of sugar when (re)formulating products and developing labels since this is a trend that will continue into the foreseeable future.

A leading meat producer has been sued over “natural” claims on deli meats. (subscription to Law360 required)

  • Challenges to “natural” claims continue, with many cases targeting “natural” claims for products containing synthetic ingredients or preservatives.  As previously covered on this blog, FDA is considering whether to regulate the term “natural”.  USDA, which regulates meat and poultry, currently has in place an informal policy on “natural” which permits USDA-regulated products to be labeled “natural” when the product does not contain any artificial flavor or flavoring, coloring ingredient, chemical preservative (as defined in 21 C.F.R. 101.22), or any other artificial or synthetic ingredient; the policy also provides that the product and its ingredients cannot be more than minimally processed.
  • On October 11, 2016, a class action lawsuit was filed against Hormel Foods Corp. alleging that it includes synthetic ingredients and preservatives in deli meat labeled as “100% Natural” or “No Preservatives”. This lawsuit comes on the heels of another “natural” lawsuit filed against Hormel by the Animal Legal Defense Fund, Public Justice, and the Richman Law Group filed in the District of Columbia Superior Court on June 30, 2016.  That lawsuit alleges that certain of the company’s natural products are derived from food animals treated with additives, hormones and antibiotics.  Hormel contends that its “natural” branded products are produced, labeled, and marketed in conformance with all applicable laws and regulation.
  • Assuming the products at issue do not run afoul of current USDA policy on “natural”, the lawsuit may face an uphill battle if the claims and labels themselves were specifically approved by USDA.

Chobani’s latest ad campaign targets ingredients in Dannon and Yoplait products

  • Yoplait and Dannon have accused competitor Chobani of using false and misleading statements about their products in Chobani’s latest ad campaign.  In newspaper, television, and social media advertisements that began airing January 6, 2016, Chobani states that unlike its Simply 100 yogurt, Yoplait Greek 100 contains potassium sorbate as a preservative and Dannon Light & Fit Greek uses the artificial sweetener sucralose, which contains chlorine.  Potassium sorbate is a common preservative, which Chobani’s ad campaign describes as “used to kill bugs.” Sucralose is an FDA-approved ingredient commonly used in reduced-calorie foods; chlorine is used to make sucralose extremely sweet without adding calories.
  • Chobani contends that the campaign “provides consumers with accurate information to help them make more informed decisions about their food choices, including the choice between natural [ingredients] and artificial [ingredients]”; Dannon argues the ads “falsely disparage the safety of harmless ingredients and unnecessarily alarm consumers as to the safety of the foods they each” and “[a]s a result, both Dannon and the public at large are harmed by [the] advertising.”
  • In recent years, consumers have become more sensitive to ingredients in the food they eat.  PepsiCo and Coca-Cola removed brominated vegetable oil from Gatorade after a teenager started a petition to have the ingredient removed from soft drinks. Subway removed azodicarbonaide after Vani Hari, better known as the “Food Babe”, branded the ingredient “the yoga mat chemical.” Whether Chobani’s latest advertising campaign represents a new trend in companies calling attention to ingredients in their competitor’s products that consumers may wish to avoid – even if the ingredients have been safely and widely used in food for years – remains to be seen.