USDA has issued a request for information (RFI) to inform the design of studies intended to assist the Agency with developing mandatory disclosure requirements for bioengineered foods.

  • As previously discussed on this blog, on July 29, President Obama signed S. 764 into law, establishing a federal framework for the labeling of genetically modified (GM) foods and food ingredients. This law directs the U.S. Department of Agriculture (USDA) to develop regulations and standards to create mandatory disclosure requirements for bioengineered foods by July 2018.
  • USDA’s Agricultural Marketing Service (AMS) has issued an RFI to help inform the design of two studies needed to establish a National Bioengineered Food Disclosure Standard.  One study will identify potential nationwide technological challenges that may impact whether consumers would be able to rely on electronic or digital links on food packages.  The second will evaluate the likelihood consumers will use electronic or digital disclosures.
  • This RFI, which primarily seeks input from vendors interested in conducting the Food Disclosure Standard studies, represents one of the first substantial Agency actions in connection with the implementation of the new federal GMO labeling law.  Comments are due to USDA by September 15, 2016.

California is considering adding aspartame to its Proposition 65 Listing. Proposition 65 is the California state law requiring labeling warnings on products containing substances “known by the state of California to cause cancer.” (subscription to Food Chemical News required)

  • Aspartame is an artificial, low-calorie, non-saccharide sweetener used as a sugar substitute and flavor enhancer in certain foods and beverages.  One of the most extensively studied substances in the human food supply – aspartame was originally approved by FDA in 1981 for uses, under specific conditions, as a tabletop sweetener, and in chewing gum, cold breakfast cereals, and dry bases for certain foods (i.e., beverages; instant coffee and tea; gelatins, puddings, and fillings; and dairy products and toppings).  In 1983, FDA approved aspartame for use in carbonated beverages and carbonated beverage syrup bases, and in 1996  FDA approved it for use as a “general purpose sweetener”.   In addition, numerous studies conducted by the FDA, the Joint Expert Committee on Food Additives (JECFA) of the World Health Organization and Food and Agriculture Organization, and the Scientific Committee on Food of the European Union (SCF) – among others – support the safety of aspartame.
  • Despite an abundance of studies from regulatory agencies in more than 100 countries supporting aspartame’s safety, aspartame will be the subject of an upcoming November 15, 2016 meeting in which the Carcinogen Identification Committee (CIC) – California’s qualified experts on carcinogenicity for purposes of Prop 65 – will be providing the state’s Office of Environmental Health Hazard Assessment (OEHHA) with advice on the prioritization of aspartame for possible preparation of hazard identification materials.  The potential listing of aspartame comes against the backdrop of FDA’s 2014 denial of two Citizen Petitions, available here and here, that sought a ban of aspartame; in denying the petitions, FDA noted that numerous studies support the safety of aspartame for use in human food among the general population.  See FDA’s denial letters here and here.
  • Given the substantial scientific literature favoring the safety of aspartame, and FDA’s fairly recent denial of petitions seeking to ban aspartame, it remains to be seen whether California will ultimately add aspartame to its Prop 65 listing.

FDA issues Draft Guidance Concerning Substantiation Needed to Support Structure/Function Claims Made in Infant Formula Labeling. 

  • In an increasingly competitive marketplace, infant formula manufacturers are incentivized to make product claims that capture consumers’ attention.  “Structure/function” claims have become popular with infant formula products – these are statements about the effect of a product or its constituents on the normal structure or function of the body. An example of a structure/function claim in infant formula labeling is a statement that the formula “supports digestion.”  FDA requires that such claims be truthful and not misleading, meaning that the claim needs to be adequately substantiated.
  • On September 9, FDA announced the availability of its first draft guidance for industry entitled, “Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling,” which describes the type and quality of evidence that FDA recommends infant formula manufacturers and distributors have to substantiate structure/function claims in infant formula labels and labeling.  81 FR 62509 (September 9, 2016).  In short, the draft guidance recommends that structure/function claims for infant formula should be substantiated with information that meets the “competent and reliable evidence” standard, consistent with Federal Trade Commission’s (FTC’s) and FDA’s approach for the substantiation of structure/function claims for dietary supplements.  Of note, the draft guidance also suggests that infant formula manufacturers consider conducting clinical research trials on infants to substantiate assertions of how their products actually function in an infant’s body, but indicates that non-infant studies would also be adequate if the mechanism of action is well-established and the data indicate no difference between infants and adults.
  • FDA asks that comments be submitted by November 8, 2016 to ensure that they are considered as the Agency works on the final version of the guidance.  Although manufacturers of all dietary supplements and food (including infant formula) have always had an obligation to support their products’ claims, the development of a specific guidance document may result in additional scrutiny of structure/function claims on infant formula labels.  As a result, infant formula manufacturers should make sure they are comfortable that their products’ claims are adequately supported.

FDA has requested comments on its “tentative conclusion” that vinpocetine is not eligible for use as a dietary ingredient.

  • Vinpocetine is a semisynthetic derivative of the vinca alkaloid vincamine, an extract from the lesser periwinkle plant.  Dietary supplements containing vinpocetine as a dietary ingredient have been on the market for roughly 20 years, although not without some controversy.  For example, in late 2015, Senator Claire McCaskill (D-MO) called for the FDA to suspend sales of supplements containing vinpocetine, noting that “the law governing dietary supplements prohibits the inclusion of synthesized ingredients like those found in prescription drugs.”
  • On September 7, 2016, FDA requested public comment (by November 7, 2016) on the regulatory status of vinpocetine.  81 Fed. Reg. 61700.  The Agency has “tentatively concluded” that vinpocetine is not eligible to be marketed as a dietary ingredient.   FDA’s request is highly unusual because the Agency had previously accepted five 75-day New Dietary Ingredient Notifications (NDINs) for vinpocetine and did not raise any concerns about the ingredient’s status when evaluating those submissions.   It is not clear what specifically triggered FDA’s decision to reevaluate the status of vinpocetine at this time.
  • FDA’s request for comments on the status of vinpocetine is not unprecedented.  In 2005, FDA published a similar request for comments on the status of pyridoxamine as part of the Agency’s evaluation of a Citizen Petition concerning the ingredient.  70 Fed. Reg. 69976 (November 18, 2005).  FDA ultimately concluded (in January 2009) that products containing pyridoxamine are not dietary supplements.  The Citizen Petition and FDA’s response can be found in Docket No. FDA-2005-P-0259 at www.regulations.gov.  It remains to be seen whether vinpocetine will endure the same fate as pyridoxamine, although it may be very difficult for proponents of vinpocetine to overturn FDA’s “tentative” conclusion.

Lawsuit alleges that an egg retailer falsely labeled eggs as “pasture raised”.

  • The term “pasture raised” is the latest labeling claim to become embroiled in controversy.  Like the term “natural” (which has been the subject of extensive consumer litigation), the term “pasture raised” is also not currently regulated at the federal level.
  • The Animal Legal Defense Fund, the Organic Consumers Association (OCA), and The Richman Law Group recently filed a complaint in D.C. Superior Court against an egg retailer alleging that its “pasture raised” eggs are actually being sourced from supplier farms that provide limited indoor space or outdoor access, thereby falling short of consumer expectations.  The lawsuit, which alleges that the “pasture raised” claims violate the D.C. Consumer Protection Procedures Act, was filed in spite of certification by the American Humane Association (AHA) touting the retailer’s eggs as “100% pasture raised”.
  • This latest case represents another example of the ongoing regulatory and litigation risk faced by food companies responding to increasing consumer demand for “clean label” foods, particularly in cases where a marketing claim is not federally defined.  The outcome of this case could dictate whether, and the extent to which, we see additional “pasture raised” consumer lawsuits, and whether FDA (the key agency regulating “shell” eggs) will ultimately consider regulating such claims, similar to FDA’s recent actions on the “natural” front.

California issues final rule adopting new “clear and reasonable warnings” required under Proposition 65.  

  • By way of background, on November 27, 2015, the California Office of Environmental Health Hazard Assessment (OEHHA) proposed to revise warnings required under Proposition 65 (Prop 65) and accepted public comments through January 25, 2016.  Subsequently, on March 25, 2016, OEHHA provided a notice of changes to the proposed regulation to repeal and add a new Article 6 to Title 27 of the California Code of Regulations (CCR) concerning “clear and reasonable warnings” under Prop 65.
  • On September 2, 2016, OEHHA announced a final rule concerning “clear and reasonable warnings” required under Prop 65.  In general, the new requirements attempt to provide consumers with more detailed information about potential chemical exposures.  In addition, the regulation seeks to clarify the relative responsibilities of manufacturers and others in the chain of distribution for providing warnings for products that are eventually sold at retail.  The issuance of this final rule effectively repeals all the regulatory provisions of Title 27 of the CCR, Article 6 (sections 25601 et seq.), except those added via an emergency rulemaking in April 2016 related to warnings for exposures to bisphenol A in canned foods and beverages (Sections 25603.3(f) and (g)).  (See our previous blog post regarding BPA specific warning requirements here).  The new warning requirements, which usher in significant changes for many manufacturers, will be operative on August 30, 2018.
  • Keller and Heckman LLP attorneys actively advise clients on compliance issues and enforcement actions related to California’s Prop 65 and are currently preparing a detailed summary of the final rule for distribution to interested parties shortly.  If you have any questions about the implications of the new warning requirements or other Prop 65 issues, please email prop65@khlaw.com.

The food industry, led by the Grocery Manufacturers of America (GMA), and Vermont have agreed to dismiss a federal lawsuit that challenged a state law requiring the labeling of certain foods made with genetically modified organisms. (Subscription to The New York Times required)

  • As previously covered on this blog, Vermont’s labeling requirements for genetically modified (GM) foods have been preempted by the recent enactment of federal GM labeling legislation which establishes a “National Bioengineered Food Disclosure Standard” and calls for the U.S. Department of Agriculture (USDA) to “establish a national mandatory bioengineered food disclosure standard”.  On August 11, 2016, Vermont’s Attorney General (AG) issued a formal memo stating that the AG’s office will no longer enforce the state’s requirements.  Still pending on appeal to the 2nd U.S. Circuit Court of Appeals in New York, however, was a federal court case filed by food industry groups against the state of Vermont challenging the state GMO labeling law.
  • Earlier this week, the parties to the lawsuit agreed the suit was no longer warranted because a new federal law preempted the Vermont law that took effect July 1, 2016.
  • The dismissal of the legal challenge to Vermont’s GMO labeling law represents the formal conclusion of a particularly controversial chapter in the GM labeling debate that involved sparring over the potential development of a patchwork of conflicting labeling requirements across the 50 states.  With the conclusion of the Vermont GMO labeling law saga, industry can now work with USDA to develop uniform federal regulation for labeling GMO foods.

 

The American Heart Association recommends dramatically reducing “added sugar” intake among children ages 2 to 18 to promote heart health.

  • Sugar continues to trend as a perennial hot topic in the food industry.  For example, earlier this year, the World Health Organization (WHO) issued a report urging the food industry and global governments to take active steps to slow sugar’s contribution to childhood obesity.  And just this past Spring, the U.S. Food and Drug Administration (FDA) published a final nutrition facts rule mandating the declaration of “added sugars” on the nutrition facts panel of packaged foods and beverages.
  • Following on the WHO report and FDA’s final nutrition facts rule, a recent American Heart Association Scientific Statement recommends that:
    • Children consume less than six teaspoons of added sugars per day;
    • Children and teens should limit their intake of sugar-sweetened drinks to no more than eight ounces weekly; and
    • Children under the age of 2 should not consume foods or beverages with added sugars, including sugar-sweetened drinks
  • Although the American Heart Association is certainly viewed as a respected public health body, decisions about appropriate regulatory responses to sugar consumption and childhood obesity ultimately remain in the hands of the federal government.   In this regard, FDA’s recently published final nutrition facts rule requiring a mandatory declaration and a daily value (DV) for added sugar as part of its comprehensive nutrition labeling revisions appears to complement the efforts of the American Heart Association to help consumers make informed decisions about the foods and beverages they purchase.  The full impact and response to the American Heart Association’s recent recommendations remains to be seen, but we anticipate that “added sugars” will continue to make headlines in the public health sphere for years to come.

 

FDA’s approval of a “potassium salt” citizen petition could represent a potential windfall for potassium chloride manufacturers while assisting food companies in complying with FDA’s goal of reducing sodium consumption.  

  • On June 26, 2016, NuTek Food Science, LLC petitioned FDA to recognize “potassium salt” as an alternate name for potassium chloride, noting that although potassium chloride has been an ingredient in food for years, consumers often conflate potassium chloride with chlorine or other chemicals.  The petition specifically requests “the commissioner to issue guidance recognizing ‘potassium salt’ as an additional common or usual name for potassium chloride as that ingredient is defined in 21 C.F.R. § 184.1622”.
  • The Salt Institute, which represents salt producers, has urged FDA to reject NuTek’s petition, arguing that granting the petitioner’s request would represent a fundamental shift in FDA’s position regarding the common or usual name for potassium chloride and, as such, should be subject to notice and comment rulemaking.  At odds with the Salt Institute, the Center for Science in the Public Interest (CSPI) supports the petition, arguing that the petition promotes truthful and accurate labeling and could potentially help reduce sodium intake.
  • FDA’s approval of this petition could represent a potential windfall for potassium chloride manufacturers while assisting food companies in complying with FDA’s recently enumerated goal of reducing sodium consumption.  At the same time, FDA’s approval of the petition could also encourage other ingredient manufacturers to request name changes for ingredients with “chemical-sounding” names.  Comments are due to FDA by December 26, 2016

An upcoming Appeals Court decision may embolden consumer advocacy groups to bypass administrative remedies in favor of the courts. (subscription to Food Chemical News required)

  • Consumer groups sued FDA in November 2014 for approving ractopamine-based feed additives used to promote faster growth and leaner meat in food producing animals such as cattle, pigs, and turkeys, alleging that FDA failed to properly consider environmental and public health risks.  Of note, the consumer groups failed to exhaust the administrative process (i.e., submitting a citizen petition with FDA) prior to filing their complaint in federal court.
  • In dismissing the complaint in November 2015, the U.S. District Court for Northern California found that the consumer groups should, in fact, have exhausted the administrative process before filing the complaint.  The Center for Food Safety (CFS) appealed the district court’s decision in December 2015 and, most recently, FDA filed a brief on August 12th urging the Ninth Circuit Court of Appeals to affirm the district court’s November 2015 decision.
  • If the court grants CFS’ appeal in this case, consumer advocacy groups may be emboldened to bypass the citizen petition process.  The result could be additional lawsuits that would otherwise be more efficiently handled at the administrative level where Agency officials could more readily address technical issues falling within their expertise.