California panel votes unanimously to add BPA to the Proposition 65 list as a reproductive toxicant.

  • 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.  Bisphenol A (BPA) has been the subject of global controversy in recent years, with multiple jurisdictions prohibiting its use in children’s products and baby bottles due to concerns about potential exposure risks.  Attempts to add BPA to the Prop 65 list date back to 2009, even though FDA’s position is that exposure to BPA is safe for humans.  BPA was added to the Prop 65 list in 2013, but was subsequently withdrawn in the wake of a lawsuit filed by the American Chemistry Council (ACC).
  • On May 7, 2015, an OEHHA panel voted unanimously to add BPA to the Prop 65 list as a reproductive toxicant, contradicting a wealth of evidence supplied by various scientific authorities who support the safety of BPA at current levels of exposure.
  • The BPA listing decision already is subject to substantial industry criticism, particularly because the voting panel considered the potentially hazardous nature of the chemical without regard to actual human exposure levels.  Between the limitations of Prop 65 (which is a warning requirement, not a safety evaluation) and the continued controversy surrounding BPA, this development serves as reminder to the food and food packaging industries that it can be hard to shake bad press once a chemical has been targeted.

Children’s Food and Beverage Advertising Initiative defends strides made in the marketing of children’s foods.

  • In the mid-2000s, concerns were raised about the extent to which children’s food marketing focused on products high in salt, sugar, and fat.  In 2006, the food industry formed a voluntary self-regulatory program called the Children’s Food and Beverage Advertising Initiative (CFBAI) with the goal of promoting healthier dietary choices and healthy lifestyles in advertisements to children under 12.
  • In April 2015, an article in the American Journal of Preventative Medicine detailed the results of a 2013 advertising survey and criticized child-targeted food ads for continuing to promote less healthy options.  Specifically, the study assessed the foods in child-targeted ads against nutritional quality standards proposed by an Interagency Working Group on Foods Marketed to Children (IWG) in 2011, which would have limited saturated fat to 1 gram or less, trans fat to less than 0.5 grams, sodium to 210 milligrams or less, and added sugars to 13 grams or less per serving.  The Director of the CFBAI issued a statement responding to the critique, defending the industry’s progress, and indicating that major candy companies have stopped advertising to children and that cereals advertised to children now have less sugar per serving and more whole grain content.
  • In the months and years ahead, the food industry is likely to remain under pressure to continue moving child-targeted food ads into healthier territory.  Particularly considering the potential regulatory developments on the horizon — including FDA’s proposal to revise the nutrition facts panel to include the declaration of “added sugars” — it will be interesting to see the results of future progress reports in this domain.

FDA issues public update regarding listeriosis outbreak linked to ice cream products.

  • FDA has many tools in its arsenal to prevent and respond to food contamination issues; these include the Agency’s inspection power and various enforcement authorities (e.g., warning letters, mandatory recall orders in class I situations, administrative detention, seizure, suspension of facility registration).  In addition to its formal authorities, the Agency also has at its disposal the power of publicity.
  • Over the past two months, Blue Bell Creameries conducted a series of high-profile recalls after its ice cream products were linked to listeriosis outbreaks in multiple states, resulting in hospitalizations and deaths.  As of April 20, 2015, Blue Bell voluntarily expanded its recall to include all products currently on the market due to potential contamination with Listeria monocytogenes.  On May 7, 2015, FDA published an update on its website alerting consumers to the scope and nature of the problem and releasing a series of inspectional observations from Blue Bell production facilities in three states.  The inspectional observations indicate that one processing facility was aware of positive tests for Listeria monocytogenes in the plant as far back as 2013.
  • Media outlets quickly began publicizing FDA’s findings, focusing on Blue Bell’s alleged longstanding awareness of a potential problem.  It will not be surprising if a host of class action lawsuits are filed in the wake of this negative publicity.  Situations such as this should serve as a reminder to the food industry that above and beyond FDA’s traditional enforcement tools, the Agency’s power of publicity should not be underestimated.

FDA publishes draft guidance on mandatory food recalls.

  • Among other things, the FDA Food Safety Modernization Act (FSMA) granted the Agency the authority to order a responsible party to recall food if there is a reasonable probability that the food is adulterated or misbranded and that use of or exposure to the food will cause serious adverse health consequences or death to humans or animals (i.e., a “Class I recall”).
  • On May 6, 2015, FDA published draft guidance for industry, in the form of questions and answers, on how FDA will use its mandatory food recall authority.  The draft guidance includes a description of the process FDA will follow when the Agency decides to move forward with a mandatory food recall; on making this determination, the Agency “must first provide . . . an opportunity to voluntarily cease distribution and recall the article of food.”  User fees and civil penalties may be imposed not only for failure to initiate a recall as ordered by FDA, but also for failure to conduct the recall “in the manner specified by FDA” or for not providing FDA with requested information related to the recall.  The guidance identifies evidence the agency “might” consider when making the decision to proceed with a mandatory recall, including:
    • Observations made during inspections of the responsible party or other parties;
    • Results from sample analyses;
    • Epidemiological data;
    • Reportable Food Registry data; and
    • Consumer and trade complaints.
  • The draft guidance highlights that FDA’s mandatory food recall authority gives the Agency greater leverage than ever over the industry in a potential recall situation.  FDA has invoked its mandatory recall authority twice so far; although in both cases the companies ultimately voluntarily recalled affected product, FDA’s actions show the Agency is not afraid to flex its mandatory recall muscle.

 

FDA may take recent consumer group comments into account before finalizing GRAS proposal next year.

  • In recent years, the “Generally Recognized as Safe” or “GRAS” exemption has come under attack from consumer groups and consumers, who argue that it permits the marketing of new food substances in the United States without sufficient agency oversight.  In 1997, FDA issued a proposed rule that effectively replaced the old GRAS Affirmation petition process with a more streamlined approach in which companies voluntarily may “notify” FDA of their GRAS determinations and FDA can issue letters stating that the Agency has “no questions” about those determinations, where appropriate.  Although FDA never finalized its 1997 proposed rule, the Agency began accepting GRAS Notices in 1998 and continues to do so.  One group — the Center for Food Safety (CFS) — sued FDA seeking to vacate the Agency’s 1997 GRAS proposal; as part of a settlement in that case, FDA committed to finalize the GRAS rule by August 31, 2016.
  • On April 15, 2015, four groups — Center for Science in the Public Interest, Consumers Union, Environmental Working Group, and Natural Resources Defense Council — filed an extensive set of comments with FDA criticizing the GRAS process and urging the Agency to rein in the food industry’s reliance on the GRAS exemption to market food substances in the United States.  During the recent Food Safety Summit in Baltimore, FDA’s Michael Taylor — Deputy Commissioner for Foods and Veterinary Medicine — made comments suggesting that FDA will be reviewing the “substantial document” it has received from these groups, leading many to wonder whether, and the extent to which, the critique will influence the contents of the final rule.
  • Although Michael Taylor did not comment on the planned contents of the final GRAS rule, he noted that FDA is also considering the issuance of guidance documents to help the industry meet FDA’s expectations regarding the criteria for GRAS substances.  The food industry, consumer groups, and consumers alike still must wait a bit longer to see FDA’s proposed “resolution” of this issue.  Particularly because the GRAS exemption is expressly codified in the Federal Food, Drug, and Cosmetic Act, many question whether consumer groups truly will be satisfied with anything short of a legislative amendment.

 

California soda warning legislation dies in committee.

  • Sugar continues to be the target of public health scrutiny, particularly as excess consumption is linked to adverse health effects.  Government agencies and legislators alike have been working to take appropriate actions to incentivize moderation in sugar intake.
  • Earlier this year, California legislators introduced a bill to require warning labels on sweetened non-alcoholic beverages, indicating that the consumption of beverages with added sugars contributes to obesity, diabetes, and tooth decay.  The bill has failed to advance past a vote in the Senate Health Committee; it is effectively dead during this legislative session.
  • Although this particular California legislative attempt may have failed, we anticipate that such efforts are far from over.  In fact, New York legislators introduced a similar bill earlier this year; that bill is still actively advancing through the legislative process.  It remains to be seen whether legislative action to address sugar consumption is a viable public health strategy.

Two major food manufacturers face class action lawsuits for using artificial trans fats in processed foods. (subscription to Law360 required)

  • Artificial trans fats are substances created by the addition of hydrogen to liquid vegetable oils to make them more solid.  The primary source of dietary trans fats in processed food is “partially hydrogenated oils” or “PHOs.”  In November 2013, FDA announced its tentative determination that PHOs are not Generally Recognized as Safe (GRAS) for use in human food.  The basis for FDA’s determination is the link between trans fat and health risks, such as coronary heart disease (CHD), as identified by scientific evidence and expert scientific panels, such as the Institute of Medicine (IOM) and the Center for Disease Control and Prevention (CDC).  
  • General Mills and Nestle USA now face class action lawsuits in California federal court due to their use of artificial trans fats in their baking mixes and coffee creamers, respectively.  The complaints — which were filed by the same firm and share the same lead plaintiff — allege that the companies deliberately chose not to use healthier, commercially available alternatives to artificial trans fats in spite of the growing consensus that trans fat consumption is unsafe.  The Nestle complaint further alleges that the company engaged in deceptive advertising by making a “0 g Trans Fat” claim on product packaging, even though this label claim is permitted under FDA regulations where a serving contains less than 0.5 g of trans fat.  In 2013, a California federal judge dismissed a similar lawsuit against Nestle and California Pizza Kitchen over their alleged use of artificial trans fat in frozen pizza products.  The dismissal was based on the plaintiff’s failure to establish an increased risk of harm associated with product consumption.
  • These lawsuits highlight the food industry’s continuing challenge regarding the use and presence of trans fat in processed foods.  Although PHO alternatives are commercially available, it is not always simple (or palatable to consumers) to simply eliminate PHOs from long-tested recipes.  FDA is expected to finalize its determination about the GRAS status of artificial trans fat later this year.  Assuming that the Agency finalizes its tentative determination, we will have to see whether a “phase-out” period is provided.  We expect that stakeholders will respond by filing a food additive permission to permit the marketing of artificial trans fat in certain food categories and/or at certain levels.  Unfortunately, we suspect that the General Mills and Nestle lawsuits will not be the last we see on this issue in the weeks and months ahead.

Chipotle announces achievement of its “non-GM” goal and now seeks to eliminate additives.

  • Genetically modified (GM) foods and food additives have been the subject of significant media attention in recent months, with topics ranging from newly-developed GM crops, to high-profile removals of specific additives by major food brands, to Vermont’s GM labeling law, to debates about the scientific consensus regarding the safety of consuming GM foods and additives generally.
  • In April 2015, Chipotle Mexican Grill announced that it will only serve food made with only non-GM ingredients, with caveats that meat and dairy products may come from animals that consume GM grain and that many beverages (e.g., soda) contain GM ingredients (e.g., corn syrup, virtually always sourced from GM corn).  The company now seeks to eliminate all remaining additives in its food (e.g., dough conditioners in the tortillas).
  • Chipotle’s announcement has been getting significant media coverage and raises questions about how the food industry should balance perceived consumer desires for “GM-free” and “additive-free” food with the fact that there is no scientific basis to seek the elimination of these substances from the food supply.  It remains to be seen which way the pendulum will swing.  Toward the elimination of safe and beneficial components from the food supply, potentially causing a scarcity of certain types of food and driving up costs?  Or toward informing consumers about the safety, acceptability, and benefits of GM foods that are engineered to resist pesticides and spoilage and additives intended to food promote safety and quality?

Bipartisan bill introduced to expand FDA’s authority over cosmetic products.

  • Although FDA currently has authority to regulate cosmetic products marketed in the United States, regulatory action in this space has been dormant for decades.  Unlike with other product categories, FDA lacks mandatory recall authority for cosmetics and manufacturers are not required to disclose adverse health effects reported by consumers.
  • In April 2015, Senators Dianne Feinstein (D-CA) and Susan Collins (R-ME) introduced the Personal Care Products Safety Act, intended to expand FDA’s regulatory authority over cosmetic products.  Cosmetic manufacturers (including ingredient manufacturers) would be subject to a facility registration requirement and would be required to pay a registration fee based on the registrant’s average gross annual sales in the United States.  FDA would have mandatory recall authority over cosmetics where exposure to such products is likely to cause serious adverse health consequences or death.  Under the bill, cosmetic companies also would be required to report “serious” adverse health events (e.g., resulting in death, disfigurement, or hospitalization) reported by consumers within 15 business days.  Cosmetic labels would need to include a domestic phone number or electronic contact information.  The bill also proposes to require FDA to issue regulations on good manufacturing practices (GMPs) for cosmetics and to review the safety of at least five different cosmetic ingredients each year.  The first candidates for a safety review would be:  (1) diazolidinyl urea (formaldehyde-releasing preservative); (2) lead acetate (color additive in men’s hair dye); (3) methylene glycol/methanediol/formaldehyde (formaldehyde-releasing chemical used in hair-straightening treatments); (4) propyl paraben (preservative); and (5) quaternium-15 (formaldehyde-releasing preservative).  Each of these ingredients has been subject to varying degrees of consumer concern and controversy in recent years.
  • The bill is supported by diverse stakeholders including members of the cosmetics industry and the advocacy group, Environmental Working Group (EWG).  Although this bill is not the first attempt to reform FDA’s regulation of cosmetics, it is the most comprehensive.  Particularly considering the support this bill has garnered from both sides of the aisle, as well as industry and consumer advocates, it potentially could be the most promising reform effort to date.

FDA issues flurry of Warning Letters to companies marketing DMBA as a dietary ingredient in dietary supplements.

  • By law, a “dietary ingredient” is defined as a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by humans to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances.  To be marketed lawfully in the United States as a dietary ingredient in dietary supplements, a substance must either be an “old” dietary ingredient marketed in the United States before October 15, 1994 or a “new” dietary ingredient (NDI) introduced to the market after that date.  For a dietary supplement containing an NDI, either: (1) the product containing the dietary ingredient must contain only dietary ingredients that have been “present in the food supply as an article used for food in a form in which the food has not been chemically altered”; or (2) the manufacturer or distributor of the product must notify FDA of the basis on which that party has concluded that that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.  The notification (called an NDI Notification or NDIN) must be submitted at least 75 days before marketing and must describe the history of use of the ingredient or other evidence establishing a reasonable expectation of safety when the dietary ingredient is used under the conditions recommended in the labeling.
  • On April 24, 2015, FDA issued Warning Letters to 14 companies regarding the marketing of products that identify the presence of 1,3-Dimethylbutylamine or “DMBA” on the product label.  FDA considers these products to be adulterated because, according to the Agency’s allegations, there is no evidence that DMBA is an “old” dietary ingredient and it does not meet the requisite NDI marketing conditions described above.  The Warning Letters also note that DMBA used in supplement products may be produced synthetically; if this is the case, FDA takes the position that synthetically produced DMBA is not a “dietary ingredient” at all under the statutory definition of that term, even though industry has strongly disagreed with this interpretation for many years.
  • FDA’s action marks a second wave of dietary ingredient-related Warning Letters within a one-week period.  As in the Agency’s recent Warning Letters related to BMPEA, FDA has not actually cited any specific health or safety concerns related to the use of supplements containing DMBA. Instead, these enforcement actions focus squarely on the “administrative problem” of selling dietary ingredients that do not meet FDA’s requirements for lawful marketing.  For years, FDA has taken relatively little enforcement action in the dietary supplement marketing arena unrelated to specific health or safety concerns.  These recent actions indicate that the Agency can strike at any time, however, and that dietary ingredient suppliers and dietary supplement manufacturers should ensure the existence of a valid legal and regulatory basis for the marketing of their products.