FDA Issues Final Rule on Food Ingredients that May Be “Generally Recognized as Safe” (GRAS)

  • Although FDA has premarket review authority over food additives, a food manufacturer can intentionally add a substance to human food or animal food without the Agency’s premarket review or approval if the substance is generally recognized, among qualified experts, to be safe under the conditions of its intended use, i.e., GRAS.   Until now, FDA has operated a voluntary GRAS Notification Program provided for under a 1997 proposed rule.
  • As part of a settlement of a lawsuit filed against the U.S. Food and Drug Administration (FDA) by the Center for Food Safety (CFS) in 2014, FDA agreed to issue a final rule on its voluntary GRAS Notification Program by August 31, 2016.  In its lawsuit, CFS claimed that FDA was operating its GRAS Notification Program under a 1997 proposed rule that was never subject to final rulemaking, essentially making the program illegal under the Administrative Procedure Act (APA).
  • With two weeks to go, on August 12, 2016, FDA released a final rule which:
    • Formalizes its GRAS Notification Program and;
    • Details the criteria for concluding that the use of a substance in human or animal food is “generally recognized as safe” (GRAS).
  • Although we do not provide a complete summary of the final rule in this blog post, we note that the final rule clarifies the criteria for eligibility for classification as GRAS as follows:
    • A substance cannot be classified as GRAS under the conditions of its intended use if the available data and information do not satisfy the safety standard for a food additive under the Federal Food, Drug, and Cosmetic Act;
    • General recognition of safety requires common knowledge, throughout the expert scientific community knowledgeable about the safety of substances directly or indirectly added to food, that there is a reasonable certainty that the substance is not harmful under the conditions of its intended use;
    • “Common knowledge” can be based on either “scientific procedures” or on experience based on common use of a substance in food prior to January 1, 1958; and
    • General recognition of safety through scientific procedures must be based upon the application of generally available and accepted scientific data, information, or methods, which ordinarily are published, as well as the application of scientific principles, and may be corroborated by the application of unpublished scientific data, information or methods.
  • Keller and Heckman attorneys are preparing an in-depth summary of the final rule for distribution shortly to interested parties, and stand ready to assist with any questions you may have regarding the implications of FDA’s final GRAS rule.  You may contact us at: fooddrug@khlaw.com.

 

Vermont AG issues memo confirming non-enforcement of GM labeling requirements.

  • As the food industry is well aware, Vermont’s labeling requirements for genetically modified (GM) foods have been preempted by the recent enactment of federal GM labeling legislation.
  • 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.
  • Although the AG’s memo is merely a formality at this point, it signals the end of a long and controversial chapter in the GM labeling debate in the U.S.  Although it will be years before the U.S. Department of Agriculture-administered GM labeling framework is up and running, the food industry can be secure in the knowledge that federal regulation precludes the development of a patchwork of conflicting labeling requirements across the 50 states.

With this post, The Daily Intake bids farewell to its creator and first Editor-in-Chief, Alissa Jijon, and welcomes Brian Sylvester to the Editor-in-Chief role.

FDA issues long-awaited revised Draft Guidance on new dietary ingredient notifications (NDINs) for dietary supplements.

  • The Dietary Supplement Health and Education Act (DSHEA) requires the manufacturer or distributor of a new dietary ingredient (NDI) to submit a pre-market notification called a new dietary ingredient notification (NDIN) to FDA at least 75 days before marketing a dietary supplement that contains an NDI (i.e., one not marketed in the U.S. prior to October 15, 1994) unless that NDI is used in the food supply without chemical alteration.  A dietary supplement is considered adulterated if the requisite NDIN is not timely submitted prior to marketing.  In 2011, FDA issued a Draft Guidance document intended to assist the supplement industry navigate the NDIN process.  However, the 2011 draft was controversially received within the supplement industry and was criticized as overly restrictive and inconsistent with DSHEA’s intent to secure broad consumer access to safe dietary supplements.  FDA agreed to reconsider and re-issue the Draft Guidance in the future.
  • On August 11, 2016, FDA issued the long-awaited revised Draft Guidance on NDIs and NDINs.  Like its 2011 predecessor, the 102-page document takes the form of a Q&A, addressing in detail the circumstances under which an NDIN is required, the contents of an NDIN, and the process and timeline associated with NDIN submission and review.  The revised draft indicates FDA’s more liberal/pro-industry positions on certain issues.  Although we do not provide a complete summary of the revised draft in this blog post, we highlight a few key revisions below:
    • FDA has expanded its discussion of what constitutes “chemical alteration” (relevant to determining whether a substance is an NDI that does not trigger notification) and expressly indicates that the few examples provided in DSHEA do not constitute an exhaustive list of processes that do not effect chemical alteration.
    • The 2011 version had indicated that synthetic botanicals could not be “dietary ingredients” at all.  The revised version clarifies that synthetic botanicals may qualify as dietary ingredients depending on the circumstances, e.g., synthetic copies of botanical ingredients that have been used as ingredients in the conventional food supply.
    • FDA has clarified its willingness to accept a single NDIN that covers multiple dietary supplements and includes safety data for a range of doses, daily intake levels, and/or other variations in conditions of use (e.g., serving size, duration of use, frequency of intake, target population, dosage form, or different formulations of pre-DSHEA ingredients in combination with the NDI).  If a dietary supplement manufacturer or distributor knows that a NDIN has been submitted to FDA that covers the conditions of use under which the NDI will be used in a particular supplement, a separate NDIN need not be submitted.
    • Unfortunately, the revised version still indicates FDA’s unwillingness to accept an ingredient’s inclusion on industry-maintained “grandfathered lists” as evidence that a substance is not an NDI.  However, the Agency now indicates that it would consider GRAS and food additive regulations as documentation of pre-DSHEA marketing status if the regulation covers the use of the substance as a supplement, became effective prior to October 15, 1994, and contains identity specifications that the ingredient meets.  FDA also has indicated its willingness to develop an authoritative list of pre-DSHEA ingredients, based on “independent and verifiable data” supplied by industry.
  • Individual supplement manufacturers and distributors are encouraged to review the Draft Guidance for issues that may be specifically relevant to their product lines and marketing practices.  Keller and Heckman LLP has significant expertise in advising the dietary supplement industry; interested parties are encouraged to email us at fooddrug@khlaw.com with any questions regarding the implications of FDA’s revised Draft Guidance.

Washington Legal Foundation files brief in support of First Amendment challenge to San Francisco soda warning.

  • As previously covered on this blog, the City of San Francisco passed legislation that requires health warnings to be placed on advertising for sugar-sweetened beverages.  Industry and advertising trade associations filed a lawsuit challenging the legislation on First Amendment grounds.  However, in May 2016, a California federal judge ruled against the plaintiffs and permitted the requirement to take effect on July 25, 2016.
  • The Washington Legal Foundation (WLF) has submitted an amicus brief supporting the American Beverage Association, the California Retailers Association, and the California State Outdoor Advertising Association in their continued efforts to challenge the ordinance on First Amendment Grounds.  The WLF brief argues that the requirement is a form of constitutionally impermissible compelled speech since it effectively forces manufacturers to denigrate their own products, at their own expense.
  • The trade associations are urging the Ninth Circuit to enjoin the San Francisco ordinance, and the case currently awaits oral argument.

FDA publishes resources to assist food industry with compliance with revised nutrition labeling requirements.

  • As food manufacturers know, in May 2016, FDA issued final rules to implement changes to the nutrition and dietary supplement labeling and serving size regulations.  Detailed summaries of both rules may be found here.
  • On August 3, 2016, FDA published a Nutrition Facts label “Industry Resources” web page to assist the food industry with compliance with the requirements of the final rules.  The new resources include:
    • Frequently Asked Questions specifically focused on industry’s common questions and concerns
    • Annotated graphic illustrations of new label specifications for the most commonly used label formats
    • High-resolution examples of label formats
    • Tables from the final rules showing daily values for vitamins, minerals, and food components, as well as reference amounts customarily consumed per eating occasion (RACCs)
    • Links to the final rules and reference materials
  • Among the FAQs — and consistent with our recommendations on this point — FDA has confirmed its current thinking that compliance with the new nutrition labeling requirements will be required for “food products that are initially introduced into interstate commerce on or after July 26, 2018 (or July 26, 2019 for manufacturers with less than $10 million in annual food sales).”  This approach is consistent with that used for the regularly scheduled labeling for the Uniform Compliance Date, where FDA bases enforcement on whether the food products are initially introduced into interstate commerce on or after the scheduled compliance date.  FDA has indicated its intent to address this issue further in guidance, so stakeholders should remain attuned to potential future developments in this area.

We return from our hiatus with a wrap-up of recent items of interest:

President Obama Signs federal GM labeling bill into law.

  • As anticipated, 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.  With this action, Vermont’s GM labeling requirements now are preempted.  For further details on the law and its implications for the food industry, click here.

FDA formally announces extension of compliance date for vending machine labeling requirements.

  • As an update to a topic recently covered on this blog, on August 1, FDA published a Federal Register notice formally extending the compliance date for certain vending machine calorie disclosures.  Specifically, the new compliance date will be July 28, 2018 — i.e., the same as the compliance date for the new nutrition labeling requirements — for certain gums, mints, and roll candy products in glass-front machines.  The compliance date for all other requirements in the rule remains December 1, 2016.

CFSAN Address Change

  • On July 1, the street address changed for FDA’s Center for Food Safety and Applied Nutrition (CFSAN).  The new address is:
    • Center for Food Safety and Applied Nutrition
      Food and Drug Administration
      5001 Campus Drive
      College Park, MD 20740

FDA launches electronic system to facilitate dairy exports.

  • Companies that wish to export products to foreign countries must comply with U.S. laws and regulations, as well as the requirements of the export markets.  FDA provides certain resources that can be helpful to companies seeking to gain access to export markets, e.g., export certificates, lists of exporting firms.
  • On July 25, 2016, FDA launched a new electronic system that U.S. manufacturers and processors of milk products can use to request inclusion on a list of eligible exporting facilities to facilitate meeting an export country’s requirements.  The FDA Unified Registration and Listing Systems (FURLS) Dairy Listing Module (DLM) is an electronic portal that U.S. dairy manufacturers and processors can use to apply for inclusion on the list, to update list information, or to reapply for listing.
  • Some foreign countries use a list to identify export-eligible U.S. manufacturers and processors.  At present, FDA maintains country-specific dairy exporter lists for Chile, China, and the European Union (EU).  Beginning on July 25, 2016, new applications and biennial updates for currently listed firms will be processed via the DLM.  Firms currently listed on the Chile, China, or EU milk product lists are encouraged to submit a new application via the DLM to ensure a successful transition to the electronic system.

The Daily Intake will be taking a brief summer hiatus until Monday, August 8.

FDA releases data from food sampling program.

  • As covered previously on this blog, since 2014, FDA has been developing a robust surveillance sampling program intended to promote food safety.  The Agency’s sampling approach involves the collection of a statistically determined number of samples of targeted foods over a 12- to 18-month period and the testing of samples for microbial contaminants.  During the first year of the program, FDA focused on sampling sprouts, whole fresh avocados, and raw milk cheese.  For fiscal year 2016, FDA indicated its intent to sample and test cucumbers and hot peppers.
  • FDA recently released final data from the sampling of raw milk cheese aged 60 days.  Based on the testing of 1606 samples from 2014-2015, FDA found raw milk cheese aged 60 days to have less than a 1 percent contamination rate for Salmonella, Listeria monocytogenes, E. coli O157:H7 and Shiga toxin-producing E. coli., and the overall contamination rate for generic E. coli was 5.4 percent.  The Agency states that it continues to be concerned about the presence of Listeria in raw milk cheese, which is a ready-to-eat food.
  • FDA also has released preliminary data from its ongoing sampling of cucumbers and hot peppers.   Of a total of 452 hot pepper samples and 352 cucumber samples, 13 hot pepper samples and 3 cucumber samples tested positive for Salmonella.  These samples were negative for the other targeted pathogens.  However, it is too early to draw conclusions from these preliminary findings.

California proposes to amend Prop 65 warning requirements for BPA in canned and bottled foods and beverages.

  • In May 2015, California’s Office of Environmental Health Hazard Assessment (OEHHA) added bisphenol A (BPA) to the Prop 65 list as a reproductive toxicant.   On April 18, 2016, OEHHA implemented an emergency regulation for BPA, providing a safe harbor warning strategy to address exposures to this chemical from packaged foods and beverages sold at retail.  The emergency rulemaking allowed the use of point-of-sale (POS) signage to indicate exposures from BPA present in cans, lids, and caps of packaged foods and beverages at retail stores until October 17, 2016.  Click here for a more detailed discussion of the emergency rulemaking and its implications.
  • On July 22, 2016, OEHHA issued a proposed rule that would permit POS signage for BPA until December 30, 2017.  The proposed rule is substantially similar to the emergency regulations promulgated earlier this year.  However, there is a significant difference in the proposal for foods that:  (1) are covered under the POS signage requirement (i.e., BPA present in the can coating, lid, or cap); and (2) do not bear an on-label BPA warning.  The proposal would require manufacturers, producers, packagers, importers, or distributors of foods in BPA-containing packages to send OEHHA specific information about the products to post on the “lead agency website” (in addition to sending similar information to retailers).  The proposal focuses on BPA that is intentionally used in food packaging.  OEHHA does not want manufacturers sending in information for posting on the lead agency website where BPA is unintentionally present.
  • OEHHA anticipates that by December 30, 2017, manufacturers either will have eliminated BPA from product packaging, labeled their products with a BPA warning, or provided retailers with shelf tags and signs.   The final compliance option produces some confusion, as OEHHA has stated that part of the rationale for the emergency rulemaking was to avoid there being hundreds of shelf tags on retail shelves.  A public hearing on the proposal is scheduled for September 12 and comments are due by September 26.

Keller and Heckman LLP attorneys actively advise clients on compliance issues and enforcement actions related to California’s Prop 65.  If you have any questions about the BPA warning developments or other Prop 65 issues, please email prop65@khlaw.com.

Complimentary Webinar TODAY:  Refresher on Food Recalls and Recall Protection

Don’t miss out!  Join Keller and Heckman partners, Art Garrett and Leslie Krasny, for a complimentary refresher webinar on recalls and what you can do now to protect your company.  The webinar is today, July 21, at 12 – 1 pm Pacific (3 – 4 pm Eastern).

For details and to register now, click here.