GNC settles NY AG challenge by pledging to implement stricter supplement controls.

  • As covered in prior posts, New York’s Attorney General (AG) has been investigating the marketing of allegedly misbranded herbal supplements.  The investigation began with the NY AG’s issuance of cease-and-desist letters to four major retailers — GNC, Target, Walmart, and Walgreens — alleging that herbal supplements sold in their stores did not contain the ingredients represented on the product labels.  The AG’s action was based on test results obtained via DNA bar coding, a method intended to detect genetic markers of the products’ botanical sources.
  • Major retailer GNC has announced a settlement agreement with the NY AG’s office.  Under the terms of the agreement, GNC commits to implement “source material traceability standards” across its product lines using DNA bar coding to confirm the authenticity of herbal/botanical ingredients.  The Company also commits to sourcing ingredients from GMP-compliant facilities certified by third parties (e.g., ISO, USP, NSF), to implementing allergen testing protocols in its supply chain, and to labeling all ingredients (including excipients) present in its products.  Further, GNC pledges to provide customer-facing materials (in-store and Internet-based) explaining the differences between whole herbs and extracts and detailing GNC’s extraction methods.  The Company also will provide semi-annual reports to the NY AG’s office related to compliance with specific provisions of the settlement agreement.
  • Aside from the precedent-setting implications of GNC’s settlement in this case, the agreement raises questions about the protective value of FDA compliance in the dietary supplement industry.  As stated in the settlement agreement, the NY AG’s office found no evidence that GNC deviated from federal good manufacturing practices (GMPs) related to dietary supplements.  Rather, the NY AG’s office calls into question the “sufficiency of federal rules and testing requirements and their relationship to state consumer protections [sic] laws.”  The agreement cites critically FDA’s failure to mandate the use of DNA-based technologies, such as bar coding, to authenticate herbal supplements.  The agreement also criticizes FDA’s allegedly inadequate purity standards under the GMP regulations, particularly with respect to the Agency’s tolerance for allergen cross-contact.  One wonders whether NY’s actions and this settlement will mark the beginning of a dual-track regulatory system for the dietary supplement industry.  In the future, it could be that FDA compliance will set merely the baseline for compliance, while state consumer protection standards will set higher — and potentially conflicting or inconsistent — standards for manufacturers and retailers to meet across the nation.

FDA and AAFCO extend MOU regarding animal food ingredient definitions.

  • Since 2007, FDA and the Association of American Feed Control Officials (AAFCO) have worked together under a memorandum of understanding (MOU) to review and sanction the use of various animal food ingredients.  Currently, animal food ingredients may be marketed on the basis of a formal FDA regulatory status (e.g., an applicable regulation) or based on an ingredient definition listed in the AAFCO manual.
  • FDA and AAFCO have now acted to extend their MOU until October 2017.
  • The extension of the MOU coincides with FDA’s recent announcement of a new strategy to harmonize the regulation of animal food ingredients in the U.S.  Since it is likely to take some time for FDA to implement its new strategy, the extension of the MOU provides the industry with at least some assurance in the meantime that the AAFCO definition process will continue to be a viable option for animal feed manufacturers.

FDA to create definitions and standards for animal food ingredients.

  • For years, animal feed and pet food ingredients have been marketed in the U.S. with the blessing of FDA and/or the Association of American Feed Control Officials (AAFCO) (a voluntary membership organization including both federal and state regulatory officials).  Currently, the lawful marketing of an animal food ingredient is based on an FDA regulation (food additive regulation or GRAS regulation), a GRAS Notification that receives a “no questions” letter, or an ingredient definition in the AAFCO manual.  FDA and AAFCO have worked together under a longstanding memorandum of understanding (MOU) to regulate animal food ingredients.
  • FDA has now announced a new strategy to establish ingredient definitions and standards for animal food.  As part of its plan, FDA will be reviewing all AAFCO listings and formally confirming those ingredients that are recognized as GRAS or approved by the Agency as food additives.  For the remaining AAFCO-listed ingredients, FDA will determine whether the existing scientific literature supports a GRAS determination or a food additive approval and will formally confirm the applicable regulatory status of the ingredients.  In cases where FDA cannot find sufficient information to make a GRAS determination or to issue a food additive approval, the Agency will require the manufacturer to submit a food additive petition to allow continued legal use of the product in animal food.
  • On the one hand, FDA’s strategy ultimately may better harmonize the field of animal food regulation across the federal and state levels.  But on the other hand, the strategy poses the potential for industry upheaval if the Agency re-evaluates certain ingredients and finds no support for GRAS status or food additive approval.  Particularly if an ingredient has a long history of safe use in the animal food supply, an FDA determination that the manufacturer must now submit a food additive petition to justify continued use is likely to incite significant industry protest.

Bill to prohibit states from requiring GM labeling reintroduced in Congress. (subscription to Law 360 required)

  • In recent years, we have seen a variety of federal, state, and local initiatives regarding the labeling of genetically modified (GM) foods.  Vermont is the only state with a GM labeling law in effect (although it is currently being challenged).  No federal legislation currently addresses this issue.
  • As anticipated, Reps. Mike Pompeo (R-KS) and G. Butterfield (D-NC) have reintroduced the Safe and Accurate Food Labeling Act of 2015, which would prohibit states from mandating the labeling of GM foods.  The bill also would create a voluntary certification process for companies that want to claim that their products are “GM-free.”
  • The Pompeo bill stands in stark contrast to the Boxer bill, which seeks to mandate GM labeling at the federal level.  It remains to be seen which, if either, of the bills will gain traction in the current Congress.

Continuing a trend, “all-natural” settlement includes no consumer payout.

  • As the food industry is well aware, numerous class action lawsuits continue to be filed in California and in other jurisdictions challenging the propriety of “natural” or “all-natural” claims for food products that contain processed ingredients and/or genetically modified ingredients.
  • In its recent settlement of an “all-natural” claim lawsuit involving fruit smoothies, defendant Jamba Juice scored a partial victory in not being required to concede liability or to pay damages to consumers.  Continuing a trend seen in several recent “natural” cases, the plaintiffs here were unable to present a viable model for calculating damages based on the allegedly deceptive “natural” claims.
  • Although “natural” litigation continues to be a thorn in the food industry’s side, the recent increase in cases and settlements in which judges have dismissed plaintiffs’ methods for calculating damages represents a hopeful trend for defendants facing similar circumstances.

FDA holding a public meeting on FSMA implementation strategy.

  • As the food industry is well aware, implementation of the FDA Food Safety Modernization Act (FSMA) is a work in progress.  FDA has issued several major proposed rules (e.g., hazard analysis and risk-based preventive control provisions, produce safety provisions) that are due to be finalized later this year.
  • On April 23-24, FDA will be holding a public meeting entitled, “FDA Food Safety Modernization Act: Focus on Implementation Strategy for Prevention-Oriented Food Safety Standards.”  FDA appears to be seeking stakeholder input on topics such as:  increasing awareness/reaching the regulated community, potential partners on outreach and implementation, state of readiness, barriers to implementation, training and education for industry and regulators, guidance needs, promotion of best practices, technical assistance, data needs, inspection changes/approaches, compliance and enforcement issues, and long-term implementation success.
  • Those interested in participating in the meeting should pre-register by April 16, 2015.  Stakeholders may attend the meeting in person or via webcast.
FDA concludes biotechnology review for GM apples and potatoes.

  • FDA encourages the developers of genetically modified (GM) food crops to submit safety information to the Agency as part of a voluntary consultation process prior to commercial distribution.
  • FDA recently completed its favorable evaluation of several varieties of apples and potatoes that have been genetically engineered to resist bruising and browning.  Specifically, the GM apples are designed to resist browning associated with cuts and bruises by reducing the levels of enzymes that cause discoloration.  The GM potatoes are designed to reduce the formation of black spot bruises, also by virtue of enzyme level reduction, and to produce less acrylamide, a chemical that can form in some foods during high-temperature cooking (e.g., frying).
  • Companies that participate in FDA’s voluntary biotechnology consultation process submit safety and nutritional information about their GM crops.  Although the Agency’s response does not constitute an “approval,” it is the closest approximation of FDA’s blessing that the developer of a GM food can obtain at this point in time.  As federal and state bills related to GM regulation and labeling continue to percolate, it remains to be seen what the future will hold for FDA’s role in premarket review of GM crops.

California appellate court ruling paves the way for using average exposure calculations to determine applicability of Proposition 65 “safe harbor.”

  • Proposition 65 is a “right to know” California statute that requires companies to provide warning statements where their products cause an “exposure” to carcinogens and/or reproductive toxicants.  California’s Office of Environmental Health Hazard Assessment (OEHHA) maintains an up-to-date list of the chemicals (>800) that trigger warnings.  The warning requirements do not apply where a particular exposure falls within the “safe harbor,” which is defined by reference to:
    • the no significant risk level (NSRL) for listed carcinogens, which is the level of a chemical calculated to result in one excess case of cancer in an exposed population of 100,000, assuming lifetime (70-year) exposure to the chemical at the level in question; or
    • the maximum allowable dose level (MADL) for reproductive toxicants, which is the level at which a chemical would have no observable effect assuming exposure at 1,000 times that level.
  • In the instant case, plaintiff – the Environmental Law Foundation – sued Beech-Nut Nutrition and other food manufacturers, distributors, and retailers, alleging that their fruit and fruit juice products, intended primarily for babies and toddlers, contain amounts of lead sufficient to trigger warnings under Proposition 65, based on the amount of lead in a product consumed in a single day.  Among other arguments, the defendants asserted that their products result in lead exposures that fall within the “safe harbor” based on the average consumer’s reasonably anticipated rate of exposure to lead from their products, including frequency of use over the relevant susceptibility time period for the reproductive toxicant.  The appellate court now has affirmed the trial court’s ruling in favor of the defendants.
  • Prior to this decision, plaintiffs in Proposition 65 litigation routinely asserted that an exposure in excess of the MADL on even a single given day triggers the warning requirement and that averaging is not permitted for reproductive toxicants.  The appellate court found no formal OEHHA policy that prohibits averaging exposure over time, even for reproductive toxicants, and further found that the defendants’ experts had used sufficiently reasonable and valid scientific methods to support their “safe harbor” conclusion.  This ruling marks a significant victory for companies who market products that contain chemicals listed under Proposition 65 as reproductive toxicants; it paves the way for companies to use appropriate averaging and rules of reason when determining the application of the “safe harbor.”

National advertising campaign launched for omega-3s.

  • Omega-3s are widely marketed and used in foods and dietary supplements in the U.S. and worldwide.
  • Citing a recent decline in the omega-3 market in North America, the Global Organization for EPA and DHA Omega-3s (GOED) has launched a nationwide advertising campaign to generate positive publicity for these ingredients.
  • In light of the potential for increased interest and publicity for this ingredient, marketers would be well-served to ensure that their use, labeling, and advertising practices comply with FDA and FTC requirements, particularly with respect to dietary ingredient use and appropriate structure/function claims.

UPDATE:  Just Mayo Back in Court

  • As previously covered on this blog, a consumer class action lawsuit alleging misleading and labeling marketing of “Just Mayo” products was filed and promptly dismissed due to the plaintiffs’ failure to establish a sufficient amount in controversy.  The plaintiffs have now re-filed the suit in Florida state court.