FDA issues final menu labeling guidance.

  • As previously covered on this blog, FDA has been in the process of implementing menu labeling provisions added to the Federal Food, Drug, and Cosmetic Act by the Affordable Care Act.  Under the new requirements, 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) must provide calorie and other nutrition information for standard menu items.  Although the menu labeling requirements were scheduled to take effect on December 1, 2015, enforcement was later delayed to December 1, 2016.  Then, due to a provision in the omnibus spending bill passed last December, enforcement was further delayed until one year after the issuance of final guidance on the menu labeling requirements.
  • On April 29, FDA announced the publication of final guidance on the menu labeling provisions.  FDA has indicated that a notice of availability will be published in the Federal Register in early May, and the Agency intends to begin enforcing the menu labeling final rule one year thereafter (i.e., in May 2017).  Click here for the text of the final guidance document, which augments the draft guidance by providing additional examples and new or revised questions and answers related to topics such as alcoholic beverages, grab-and-go items, and recordkeeping requirements.
  • Now that FDA has issued final menu labeling guidance, there is likely nothing short of federal legislation that will further extend the enforcement date.  Covered entities should be developing compliance strategies and familiarizing themselves with the final guidance document in preparation for compliance by May 2017.

Senator Markey sends letter to FDA criticizing GRAS review system.

  • As the food industry is well aware, consumer groups and others have been criticizing the “Generally Recognized as Safe” or “GRAS” exemption in the U.S. for the past several years.  GRAS opponents criticize FDA’s alleged lack of oversight and direct involvement in the marketing of GRAS substances.
  • On April 26, Senator Edward Markey (D-Massachusetts) sent a letter to FDA, characterizing the GRAS exemption as a “loophole” that “challenges the statutory intent of FDA’s assignment to protect the safety of the food supply.”  The letter criticizes the “loose structure” of FDA’s voluntary GRAS Notification program and expresses concern about the marketing of “self-determined” GRAS substances and perceived conflicts of interest in the system.  The letter concludes with Sen. Markey requesting FDA’s response to questions about:  (1) the Agency’s authority to require labeling on self-determined GRAS substances (e.g., “The safety of some ingredients in this product has not been evaluated by the Food and Drug Administration.”); (2) the Agency’s authority to mandate requirements to minimize conflicts of interest in GRAS self-determinations; and (3) steps the Agency has planned to strengthen its oversight of GRAS substances.
  • Because the GRAS exemption is expressly codified in law, it is not clear that FDA regulatory action alone would appease the opponents of GRAS.  As part of a settlement of a lawsuit filed against FDA by the Center for Food Safety in 2014, FDA has agreed to issue a final rule on the GRAS review program by August 31, 2016.  Thus, whether or not the Agency responds to Sen. Markey’s entreaty, we anticipate concrete developments on the GRAS review front later this year.

CDC issues Cronobacter warning for powdered milk and infant formula products.

  • Cronobacter (formerly known as Enterobacter sakazakii) is a bacterium that occurs naturally in the environment and that can survive in dry foods, such as powdered infant formula, powdered milk, herbal teas, and starches.  Although Cronobacter-related illness is rare, it can prove fatal to infants.
  • The Centers for Disease Control (CDC) recently issued a new warning to address Cronobacter contamination and steps that consumers can take to protect infants, including instructions to promote the safe handling, preparation, and storage of infant formula.
  • Although FDA’s current good manufacturing practice (GMP) requirements for infant formula include a limit for Cronobacter (neg/10 g based on 30 samples), infant formula manufacturers report that it is not possible to ensure zero contamination risk using current methods.  Also, powdered infant formula may become contaminated after containers are opened.  For these reasons, and because Cronobacter poses a fatal risk to the infant population, the CDC seeks to leverage public awareness and education as a useful preventive approach.

OSHA issues final rule implementing FSMA whistleblower provisions.

  • The FDA Food Safety Modernization Act (FSMA) added section 1012 to the Federal Food, Drug, and Cosmetic Act (FD&C Act) to provide added protection for employees who “blow the whistle” and come forward with information about potential food safety problems within their companies or facilities.  Although Section 1012 took effect upon FSMA’s enactment in 2011, the Department of Labor (and not FDA) is responsible for enforcing the employee protection provision of the law.  To implement this provision, the Department of Labor’s Occupational Safety and Health Administration (OSHA) issued an interim final rule (IFR) in February 2013 and provided an opportunity for public comment.
  • On April 18, OSHA issued its final rule to implement the FSMA whistleblower provisions.  Having received responsive comments from only two organizations, OSHA adopted the final rule with only minor revisions to the IFR.  The final rule establishes procedures for employees who seek to file retaliation complaints under FSMA’s whistleblower provision.  The rule also specifies procedures that OSHA and employers must follow when investigating and responding to such complaints, as well as procedures for filing objections to the agency’s findings and for requesting a hearing.  Employees must file retaliation complaints within 180 days of the alleged retaliatory activity, and meritorious complaints may result in employees being entitled to a variety of remedies, such as reinstatement, back pay, and compensatory damages.
  • The whistleblower provision and OSHA’s final regulations in this area play a key role in implementing FSMA’s prevention-based approach to food safety in the United States.

For more information about Keller and Heckman’s OSHA and Employment practice, click here.  To sign up for complimentary webinars that provide topical updates on OSHA issues (OSHA 30/30 — a 30-minute update on OSHA law every 30 days), click here.

Vermont weighs potential delay in enforcement of GM labeling law.

  • As the food industry is well aware, Vermont’s labeling requirements for genetically modified (GM) foods are set to take effect on July 1 of this year, with a six-month “safe harbor” provision thereafter.
  • A media report indicates that the Vermont Retail & Grocers Association (VRGA) — a trade association representing the majority of Vermont food retailers — is publicly supporting an amendment under consideration by the Vermont Senate to delay the private cause of action under the GM labeling law until December 31, 2017.  It does not appear that this delay would change the effective date of the requirements themselves.
  • Although VRGA supports GM labeling as a general premise, the association reportedly believes that delaying the private cause of enforcement will aid in smoother implementation of the new requirements, particularly as many questions remain about labeling mechanics and many labels may not be fully compliant by July 1.  We will continue to monitor and report on any concrete developments that may result in delayed enforcement of the Vermont GM labeling law.

Styrene added to Proposition 65 list.

  • 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 (>900) 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.
  • Effective April 22, 2016, OEHHA has added styrene (CAS No. 100-42-5) to the Proposition 65 list.  The listing action is based on formal identification by the National Toxicology Program (NTP) that the chemical is “reasonably anticipated to be a human carcinogen.”  OEHHA also has proposed an NSRL for styrene of 27 µg per day.
  • The listing of styrene has been in the pipeline for many years, so OEHHA’s current action comes as little surprise to the industry.  We anticipate that many stakeholders have been evaluating the potential impact of the styrene listing on their product lines and warning obligations for some time.  Comments on the proposed NSRL are due by June 6, 2016.

New studies question use of DNA barcoding to authenticate botanical dietary supplements.

  • In 2015, the New York Attorney General (NY AG) launched a high-profile investigation into the marketing of botanical dietary supplements, culminating in backlash against herbal supplements and a landmark settlement with a major supplement retailer.  However, the NY AG investigation was mired in controversy due to its lack of transparency and complete reliance on DNA barcoding as the apparent “gold standard” for assuring the identity and purity of herbal/botanical ingredients.
  • Earlier this month, new data were presented that call into question the utility of DNA barcoding by itself as a means of authenticating botanical ingredients in supplements.  Two new studies were presented by an FDA scientist (research coordinator for dietary supplements) and by an Australian research consortium at the 16th Annual Oxford International Conference on the Science of Botanicals.  The FDA data compared the results of high performance liquid chromatography (HPLC) analysis and DNA barcoding of five popular botanical ingredients.  When 112 products were analyzed using both techniques, the results indicated that 111 contained marker compounds. However, when the products were tested by DNA barcoding alone, only 31 of the 112 products were found to contain DNA from the labeled ingredient.  Similar conclusions were reached in the Australian study.
  • Although FDA has not taken an official position on the use of DNA barcoding as an authentication method, these data continue to call into question the validity of this method as applied to identifying botanical ingredients.  Industry experts have long claimed that DNA barcoding is not a suitable method for authenticating botanical extracts because DNA material in these components may be of low quality or degraded to a point that generates false negatives in analytical testing.  Although it is too early to tell how influential these new data will be in the context of regulatory enforcement and plaintiffs’ class action lawsuits against the supplement industry, they contribute empirical evidence to the debate over the appropriateness of overt reliance on barcoding alone in this area.

FDA approves folic acid fortification of corn masa flour.

  • Although many food ingredients are marketed in the United States on the basis of their “Generally Recognized as Safe” or “GRAS” status, FDA still must approve “food additives” via the approval of a formal food additive petition (FAP).  The FAP route generally is unpopular with the food industry because of the onerous submission requirements and the multi-year approval timeline.
  • FDA recently approved the use of folic acid to fortify corn masa flour, specifically permitting manufacturers to voluntarily add up to 0.7 mg of folic acid per pound of corn masa flour.  This level of fortification is consistent with those already permitted for certain other enriched cereal grains.
  • The corn masa fortification petition was submitted in April 2012 by the March of Dimes Foundation and the American Academy of Pediatrics, among other stakeholders who sought this additional avenue of fortification to reduce the incidence of neural tube defects (NTDs) among populations who regularly consume products made from corn masa flour as a staple in their diet (e.g., women of Latin American descent).  Although FDA’s approval is being met with praise, the four-year approval timeline serves as a continued reminder to the industry of the lengthy nature of the food additive approval process.

California launches Prop 65 Warning Website.

  • As previously covered on this blog, California has been in the process of revisiting its Prop 65 regulations, which may eventually include changes to the safe harbor warnings.  As part of this process, a final regulation took effect on April 1, 2016, establishing a framework for a new website administered by the Office of Environmental Health Hazard Assessment (OEHHA) to provide supplemental information to the public about warnings they receive for exposures to Prop 65 listed chemicals.
  • Earlier this month, OEHHA officially launched its Lead Agency Website at www.P65Warnings.ca.gov.  In keeping with the implementing regulation, OEHHA intends for the site to be a forum for posting more detailed information on chemicals listed under Prop 65 and products containing listed chemicals.  The current version of the site contains limited information on a few product types (alcohol, furniture, petroleum, and raw wood products) and places (i.e., amusement parks, dental offices, smoking areas, enclosed parking lots, service stations, and vehicle repair shops).  Each listed chemical has its own page and tells you the basis for the listing (e.g., female reproductive toxicant, carcinogen, etc.).  However, expect the website to expand as OEHHA starts sending out requests to manufacturers.
  • California will be obtaining information to populate the website directly from industry.  For industry stakeholders, this means that if a product bears a Prop 65 warning, you may receive a request from OEHHA to provide the information on the location of the chemical in the product, the concentration (including mean, minimum, and mode) of the listed chemical in the final product, anticipated routes of exposure, estimated levels of exposure, and “any other related information concerning exposures to listed chemicals.”  OEHHA may post this information on its website (unless you can successfully argue that it is privileged or confidential).

K&H publishes summary of FSMA final rule to implement sanitary transportation requirements for human and animal food.

  • As promised, Keller and Heckman LLP has prepared a summary of FDA’s final rule to implement sanitary food transportation requirements under the FDA Food Safety Modernization Act (FSMA).
  • Click here for our summary of the rule and its implications for entities in the food industry.
  • Although the core components of the sanitary transportation requirements remain substantially similar to those in the proposed rule, FDA has revised and clarified the final rule in several key respects.  Of particular significance to specific industry sectors, FDA has now excluded the transportation of the following product categories from the scope of the rule:  (1) food-contact substances; (2) human food byproducts transported for use as animal food without further processing; and (3) food completely enclosed by a container, except food that requires temperature control for safety.  Responding to the concerns of many stakeholders, FDA also has expressly recognized that parties permissibly may reassign responsibilities under the rule by reliance on written agreements.

We will continue to monitor and report on FDA’s activities to implement this rule and other FSMA related activities.  Please email fooddrug@khlaw.com and let us know if you have any questions or if you would like to discuss the impact of the final rule or any other FSMA related issues in the meantime.