Sugar industry wraps up case-in-chief against corn syrup group in false advertising lawsuit.

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  • For years, the sugar and corn syrup industries have been battling it out in California federal district court over allegations of false advertising.  The Western Sugar Cooperative initially filed suit in 2011, accusing the Corn Refiners Association (CRA), among others, of misleading the public with a marketing campaign promoting high fructose corn syrup (HFCS) as nutritionally identical to sugar and disputing CRA’s claim that “sugar is sugar”. CRA Member Companies Archer-Daniels-Midland, Cargill, Ingredion (formerly known as Corn Products International), and Tate & Lyle Ingredients Americas countersued in 2012, claiming that the sugar industry was smearing HFCS to persuade consumers to buy products sweetened with sugar.
  • The sugar industry wrapped up its case-in-chief yesterday.  In support of its allegations that the HFCS industry knowingly made false claims that HFCS is equivalent to sugar, the sugar industry presented a 1998 trade brief filed by the CRA in Mexico that declares HFCS to be distinct from sugar.  The sugar industry also presented testimony from Dr. David L. Katz, director of Yale University’s Prevention Research Center, who stated that he was particularly wary of HFCS since less is known about its health impacts and the sweetener was mostly found in highly processed foods.
  • The court’s decision in this case will certainly have implications for both the HFCS and sugar industries with respect to who will ultimately capture the sweetener market, the driving force underlying the ongoing legal battle.  From a regulatory standpoint, it remains to be seen whether a favorable outcome in this case for HFCS (i.e., that “sugar is sugar”) would have any impact on FDA’s 2012 decision that “corn sugar” may not be used as an alternate common or usual name for HFCS.

FDA issues its first marketing authorizations for new tobacco products.

  • FDA has the authority to regulate various tobacco products (cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco) under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control Act).  A “new tobacco product” is defined, in pertinent part, as any tobacco product that was not commercially marketed in the United States as of February 15, 2007 (i.e., is not grandfathered); or any modification (including a change in any design, component, part, constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the U.S. after the February 15, 2007 grandfather date.
    • There are three distinct methods by which manufacturers may obtain marketing authorization to introduce new tobacco products into interstate commerce: (1) submission of a Premarket Tobacco Product Application (PMTA); (2) submission of a Substantial Equivalence (SE) Report comparing the new product to a valid grandfathered (predicate) product; and (3) submission of a request for an exemption from SE requirements for minor modifications.
    • Under the more onerous PMTA pathway, manufacturers must demonstrate (among other things) that the marketing of the new tobacco product would be appropriate for the protection of the public health.  To enforce this standard, FDA must consider the risks and benefits to the population as a whole, including users and non-users of tobacco products.
  • On November 10, 2015, FDA issued its first market authorizations in response to PMTAs.  Specifically, the Agency has authorized the marketing of eight snus smokeless tobacco products.  In its press release announcing the authorizations, FDA reiterates that its action does not mean the products are “safe” or “FDA approved.”  In fact, the Tobacco Control Act makes clear that companies cannot position their products as “FDA approved.”  Also, companies must separately apply for, and receive, a separate modified risk tobacco product (MRTP) authorization to permit claims of reduced exposure or reduced risk.  The current PMTA actions are marketing authorizations and do not constitute MRTP authorizations.
  • FDA’s actions have set long-awaited precedent that should give the tobacco industry insight into how FDA intends to evaluate PMTAs and what final marketing orders will look like.

For more information about our tobacco & e-vapor regulatory practice in general, click here.

FDA issues three long-awaited final rules to implement FSMA provisions.

FDA has issued final rules to implement three major provisions of the FDA Food Safety Modernization Act (FSMA).  The rules are scheduled for publication in the Federal Register on November 27, 2015.

  • Click here for FDA’s overview of the final rule to implement the produce safety standards and here for the full text of the final rule (pre-publication version).
  • Click here for FDA’s overview of the final rule to implement the foreign supplier verification program (FSVP) for importers of food for humans and animals and here for the full text of the final rule (pre-publication version).
  • Click here for FDA’s overview of the final rule to implement the third-party certification program and here for the full text of the final rule (pre-publication version).

Keller and Heckman LLP is preparing full analyses of these three final rules and continues to provide legal advice and support to growers, food processors, ingredient suppliers, and other stakeholders related to FSMA compliance.

Food producer settles class action lawsuit involving “all natural” claims for cooking oil made from GM crops.

  • Challenges to “natural” claims continue to proliferate in court rooms across the United States, with many cases targeting “natural” claims for products derived from genetically modified (GM) crops.  FDA’s informal policy is that “natural” means nothing artificial (including artificial flavors) or synthetic (including all color additives regardless of source) has been included in or has been added to a food that would not normally be expected to be in the food.  The policy leaves room for debate over whether products derived from GM crops can be considered “natural.”
  • In a high-profile class action lawsuit challenging “all natural” claims for Crisco cooking oil, the parties now have entered into a settlement agreement to resolve the case.  Although the settlement brings an end to this particular challenge, it does not yield any guiding principles that would eliminate future confusion over the use of “natural” claims for GM-derived products.
  • Earlier this week, FDA surprised many stakeholders by jumping into the “natural” fray and requesting public comment on the meaning of the term.  In its request, FDA specifically posed the question of whether the use of genetic engineering should influence the applicability of “natural” terminology.  It remains to be seen whether, how, and when the confusion over the intersection between GM foods and “natural” foods will be abated.

NY Senator urges FDA to investigate the safety of caffeinated peanut butter. 

  • There is ongoing debate and concern about the safety of caffeine consumption, particularly as related to certain food products produced to deliver high doses of caffeine in small servings.  In recent months, FDA issued a series of Warning Letters to distributors of powdered caffeine and posted information on its website to warn consumers about the potential dangers associated with consuming the product.
  • Senator Charles Schumer (D-NY) has issued a press release and a letter to FDA to express his concerns about the potential safety risks associated with a new caffeinated peanut butter product.  The producers of the product state that a single serving of the product (two tablespoons) provides approximately the same amount of caffeine as two cups of coffee.  Senator Schumer notes that the product provides five times more caffeine per serving than a single can of Coke and the same amount of caffeine as two Red Bulls.  The Senator appears particularly concerned for children’s safety because peanut butter is such a popular snack food among young consumers.
  • FDA previously has grappled with the caffeination of food products and has taken action with respect to products such as a caffeine inhaler, caffeinated alcoholic drinks, and caffeinated chewing gum.  It remains to be seen whether FDA will take action related to caffeinated peanut butter.  Either way, concerns about innovative caffeine delivery sources in the food supply are unlikely to vanish anytime soon.

FDA requests comments on “natural” definition.

  • As food industry stakeholders are well aware, the use of the term “natural” in food labeling and advertising is fraught with ambiguity and risk of challenge.  FDA’s informal policy is that “natural” means nothing artificial (including artificial flavors) or synthetic (including all color additives regardless of source) has been included in or has been added to a food that would not normally be expected to be in the food.  In reality, however, the definition of “natural” frequently is revisited and restricted by the litigation landscape.
  • FDA is now officially requesting information and public comment on the use of the term “natural” in food labeling.  In explaining the motivation for the request, FDA noted its receipt of multiple Citizen Petitions requesting a formal definition for the term “natural.”  The Agency also noted its receipt of multiple requests from federal courts seeking FDA’s views on whether foods containing genetically modified (GM) ingredients or foods containing high fructose corn syrup may be considered “natural.”
  • In its request for comment, FDA poses a series of questions regarding whether/how to define the term “natural.”  Agency action in this area ultimately may be dictated by federal GM labeling legislation; the House bill passed in July 2015 would require FDA to define the term “natural” for use on food labels.  In the meantime, FDA invites comment on nuanced issues such as whether manufacturing processes should be considered in determining whether a food may be called “natural”; whether and how consumers compare/confuse “organic”, “natural,” and “healthy”; and whether the use of genetic engineering should influence the applicability of “natural” terminology.  FDA will be accepting comments on the “natural” definition until February 10, 2016.

FDA issues Q&A guidance on food fortification policy.

  • Since 1980, FDA has had a formal fortification policy for foods, codified in 21 CFR 104.20.  The policy provides a series of guiding principles regarding the conditions under which FDA views the addition of essential nutrients to foods as appropriate.
  • FDA has issued a guidance document (in Q&A format) to address questions about the existing food fortification policy.  The guidance does not change FDA’s policy, but provides clarifications and consolidates information about the fortification principles into a single document.  As before, FDA considers it inappropriate to fortify certain foods, such as fresh produce; meat, poultry, or fish products; sugars; or snack foods such as candies and carbonated beverages.
  • FDA’s fortification policy can be a source of confusion for food processors.  Although the policy is codified in FDA regulations, compliance is mandatory only where a company wishes to make a “more” claim (including “more,” “fortified,” “enriched,” “added,” “extra,” and “plus”) or a “healthy” claim (including related terms).  This is because the nutrient content claim regulations that govern “more” claims (21 CFR 101.54(e)) and “healthy” claims (21 CFR 101.65(d)(iv)) specify that where nutrients are added to the food to achieve the 10% level required to support the claim, such fortification must be done in accordance with FDA’s fortification policy.  FDA enforces the fortification policy by issuing Warning Letters where marketed foods bearing “more” or “healthy” claims contain nutrient additions that are inconsistent with the official policy.  In all other cases, FDA “strongly encourages” companies to follow the fortification guidelines.

House panel approves bill to loosen FDA’s menu labeling requirements for food retail establishments.

  • As previously covered on this blog, starting on December 1, 2016, FDA will require restaurants or similar retail food establishments (in chains of 20 or more locations doing business under the same name and selling substantially similar menu items) to provide calorie and other nutrition information for standard menu items.  This requirement has been criticized as unduly onerous, particularly with respect to its application to locations such as grocery stores, convenience stores, and pizza parlors that market highly variable menu items.  Some have estimated compliance costs for the industry at more than $1 billion.
  • The House Energy and Commerce Subcommittee on Health now has approved a bill that would loosen the application of FDA’s menu labeling requirements under certain circumstances.  The bipartisan Common Sense Nutrition Disclosure Act would amend the Federal Food, Drug, and Cosmetic Act to make compliance more workable for locations (such as pizzerias) where the majority of orders are placed by customers off-premises (e.g., via Internet or phone) and to give locations greater flexibility in determining how to disclose nutrition information for multi-serving products with the potential for significant compositional variation (e.g., pizzas with numerous topping combinations).
  • The food retail industry generally supports Congress’ initiative to lessen the impact of the rule.  The House bill now proceeds to the full Committee for further consideration, and a companion bill also is working its way through the Senate.

Leading trade association plans to develop voluntary dietary supplement registry.

  • Under the Federal Food, Drug, and Cosmetic Act, FDA has the authority to regulate dietary ingredients and dietary supplements.  Although these substances and products are a subset of the “food” category, they are subject to a distinct regulatory regime under the framework of the Dietary Supplement Health and Education Act of 1994 (DSHEA).  For years, FDA and the dietary supplement industry have tussled over the extent of the Agency’s ability to restrict consumer access to safe supplements.  One topic of ongoing debate is the alleged lack of transparency regarding the composition of supplements currently on the market.
  • A leading dietary supplement trade association — the Council for Responsible Nutrition (CRN) — has adopted a proposal to create a Voluntary Product Registry for Dietary Supplements.  According to CRN, the goal of the registry is to increase transparency and give regulators greater access to information about the composition of supplement products currently on the market.
  • CRN continues to seek input from other affected stakeholders regarding its plan.  The organization acknowledges that some will likely see the database as needless, while others will think it does not go far enough.  The degree to which FDA and the dietary supplement industry will embrace this initiative remains to be seen, and the timeline for implementation is not yet clear.

Judge dismisses class action lawsuit, ruling that even prominent pictorial label representations may not necessarily mislead.  (subscription to Law360 required)

  • Much debate exists about the extent to which graphic or pictorial representations on food labels may or may not deceive consumers as to product composition.  In a case filed recently in the “Food Court” (Northern District of California), a plaintiff challenged a food manufacturer for using prominent photos of food ingredients on the front of labels for puree pouches where those ingredients were not the only ingredients present and where other ingredients were present in greater proportions.
  • On November 2, 2015, a federal judge dismissed the lawsuit for failure to state a claim for relief.  In contrast with other decisions in this arena, the judge stated that “a reasonable consumer would simply not view pictures on [food packaging] and assume that the size of the items pictured directly correlated with their predominance in the blend” and that “[e]very reasonable shopper knows that the devil is in the details.”  The judge further found that “any potential ambiguity could be resolved by the back panel of the products, which listed all ingredients in order of predominance, as required by the FDA.”  The ruling distinguished the instant case from other situations in which label claims or graphics made affirmative misrepresentations, e.g., displaying ingredients not actually contained in the products or stating that products were made with “other all natural ingredients” when many ingredients were synthetic.
  • Although the dismissal of this case is a positive development for the food industry, it will not necessarily end the debate over whether “FDA-compliant” label claims and graphics will insulate food companies from challenge.  In contrast, in a highly-publicized case involving a Lanham Act challenge over a “Pomegranate Blueberry” juice beverage that contained very limited quantities of pomegranate juice and blueberry juice, the Supreme Court unanimously held that the lawsuit could continue even where the labeling may conform with FDA regulations.  In that case, much debate centered around the use of label claims and graphics that arguably were deceptive despite technical compliance with FDA requirements.  We suspect that this debate is far from over.  It remains to be seen whether the plaintiff in this case will appeal the dismissal order, or whether the current decision will stand and potentially raise the bar (at least in the Food Court) for pleadings regarding whether particular food claims and graphics are deceptive in the overall context of a product label.