FDA Issues Draft Guidance for Labeling Supplements with Live Microbials

  • FDA published a final rule on May 27, 2016 (“Food Labeling: Revision of the Nutrition and Supplement Facts Label”) which updated the requirements for Nutrition and Supplement Facts labels.  For more see the Daily Intake blog posts here and here.   In the preamble to the rule (81 FR 33742, 33933), FDA addressed a comment suggesting that the rule should “permit the use of additional units of measure for dietary ingredients to allow for use of more appropriate measure when metric weight is not the most accurate way to express the quantity of the dietary ingredient”.  The comment suggested that Colony Forming Units (CFUs) and enzyme assay units (e.g. HUT, PC, SU, and ALU) would be appropriate for probiotics and enzymes respectively.  FDA declined to make the proposed change, stating “[w]e need to fully evaluate each unit of measure for dietary ingredients to determine if it is appropriate for use on the Supplement Facts label” and to determine whether there would be any other implications.  FDA further indicated that it planned to “issue information related to this subject at a later date.”  FDA subsequently received a citizen petition from the International Probiotics Association requesting that the permitted unit for reporting live microbials be changed from weight to CFUs in the regulation.
  • In today’s Federal Register, FDA announced the availability of Draft Guidance for Industry: Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials.  Having had a chance to consider the issue further, including via the review of submitted comments relating to the International Probiotics Association citizen petition, FDA is announcing its intent to exercise enforcement discretion for the declaration of the quantity of live microbials in CFUs in the Supplement Facts label for dietary supplements under certain conditions.  The conditions are:
    • The quantity must first be listed in terms of weight;
    • The quantity in CFUs must be “expressed in a manner that is clearly separate and readily distinguishable from the weight”;
    • The declaration of quantity in CFUs must be formatted in terms that can clearly be understood by a common reader;
    • The declaration of quantity in CFUs is accurate and does not render any other aspects of the remainder of the Supplement Facts label or the remainder of the label false or misleading;
    • The declaration of quantity of CFUs only measures live microbials; and
    • The product label otherwise complies with all applicable laws and regulations.
  • FDA determined that, under the conditions listed above, permitting the additional declaration on the Supplement Facts label of CFUs of live microbials would enable consumers to more easily compare dietary supplements and would provide consumers increased confidence that dietary supplement products contain the labeled amount of live microbial ingredients.
  • FDA is aware that researchers are evaluating methods and units that might be a more efficient or accurate means of quantifying the number of viable cells in a product.  FDA indicates in the draft guidance that it intends to monitor the development of new technologies before deciding to engage in rulemaking to modify the regulation.  However, because companies are in the process of preparing new labels to comply with the Nutrition and Supplement Facts Label Final Rule in advance of the January 1, 2020 (manufacturers with $10 million or more in annual food sales) or January 1, 2021 (manufacturers with less than $10 million in annual food sales) compliance date, FDA intends to exercise enforcement discretion until it decides whether to engage in rulemaking.
  • Companies requiring assistance with label compliance are encouraged to contact Keller and Heckman at fooddrug@khlaw.com.

USDA Bioengineered Food Labeling Final Rule Sent to OMB for Review

  • In a sign of progress, the Office of Management and Budget (OMB) received the U.S. Department of Agriculture’s (USDA) final rule for the National Bioengineered Food Disclosure Standard (NBFDS) on August 31, 2018 – less than two months after the comment period closed on the proposed rule for the NBFDS on July 3, 2018. As previously reported on this blog, on August 7, 2018, USDA filed an additional six bioengineered food symbols with the U.S. Patent and Trademark Office, signaling that USDA was working to finalize its final rule. The statutory deadline for completion of the final regulations was July 29, 2018.
  • As an economically significant regulatory action under Executive Order 12866, the final rule must go through the 12866 review process, which involves interagency Executive Branch review before final publication, coordinated by the Office of Information and Regulatory Affairs (OIRA) in OMB.  The period for OIRA review is limited to 90 calendar days after the date of submission, which can be extended indefinitely by the agency head or by the OMB Director for no more than 30 days.
  • However, OMB went over the 90 day limitation when USDA submitted its proposed rule for the NBFDS to OMB on December 26, 2017, and when asked about the publication date for the proposed rule in April 2018, Secretary Perdue placed responsibility for the delay of the proposed rule in part on OMB. At that time, Perdue noted that the Department requested the process be expedited but struggled to receive timely input from OMB, “we turned in our papers on time; the teachers didn’t grade them on time,” Perdue said of OMB. OMB ultimately completed their review on April 30, 2018, well over the 90-day limitation under EO 12866. If OMB sticks within the 90-calendar day review period, publication of the final rule for the NBFDS could occur by the end of November 2018.



FDA Expands ANAB Recognition under the Accredited Third-Party Certification Program

  • The Food Safety Modernization Act (FSMA) established the Accredited Third-Party Certification Program, which is a voluntary program that allows “accreditation bodies” to apply for recognition by FDA. Recognized accreditation bodies have the authority to accredit third-party “certification bodies,” otherwise known as third-party auditors. In turn, the certification bodies (1) conduct consultative and/or regulatory food safety audits and (2) issue certifications to eligible entities that produce food for humans and animals.
  • As previously mentioned on this blog, FDA has recognized four accreditation bodies, ANSI-ASQ National Accreditation Board (ANAB), the American National Standards Institute (ANSI), the National Bureau of Agricultural Commodity and Food Standards (ACFS), and the International Accreditation Services, Inc. (IAS) to assess and accredit certification bodies.
  • Today, FDA notified stakeholders of the recently expanded scope of ANAB’s recognition under the voluntary Accredited Third Party Certification Program. Effective August 23, 2018, ANAB is recognized for the following additional scopes:
    • Acidified Foods (AF),
    • Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers (LACF),
    • Hazard Analysis and Critical Control Point (HACCP) for Juice (Juice HACCP), and
    • Fish and Fishery Products (Seafood HACCP).
  • ANAB’s initial recognition included the following scopes:
    • Preventive Controls for Human Food rule (PCHF),
    • Preventive Controls for Animal Food rule (PCAF), and
    • Produce Safety Rule (PSR).
  • Prior to this expansion, IAS was the only recognized accreditation body whose scope of authority included FDA regulations on LACF and AF. The expansion of ANAB’s recognition means there are more opportunities for certification bodies to become accredited under the program.

Please feel free to contact Keller and Heckman at fooddrug@khlaw.com with any questions about FSMA or the Accredited Third Party Certification Program.

FDA Announces New Export Certification Program

  • The U.S. Food and Drug Administration (FDA) recently announced a new export certification program, along with the fees that will be assessed, for certain FDA-regulated food products. The fees will apply to products, such as produce, grains, processed foods, food additives, color additives, food contact substances, and infant formula.
  • “We anticipate that this new export certification will facilitate trade by assisting U.S. food exporters in fulfilling importing country requirements for FDA certification of FDA-regulated food products,” explained FDA Commissioner Scott Gottlieb, M.D, in an announcement about the new export certification program.
  • By way of background, in 1996, Congress added a new statutory provision to the FD&C Act that stated any person who exports a drug, animal drug or device may request the FDA certify in writing that the exported product meets certain requirements. The law also authorized FDA to charge up to $175 for each certification. The FDA Food Safety Modernization Act (FSMA) of 2011 added foods to the listed of covered products.
  • FDA announced the fees that it will assess for issuing the export certificates for food in the September 4, 2018 Federal Register. The fee for the first certificate will be $175, the fee for the second certificate for the same product(s) issued in response the same request will be $155, and a $100 fee will be assessed for subsequent certificates issued for the same product(s) in response the same request. FDA will begin issuing and collecting fees for the new export certificates on October 1, 2018.
  • Prior to the launch of this new certification program, the FDA issued other types of certifications for exported foods, such as “Certificate of Free Sale” for dietary supplements, medical foods and foods for special dietary uses. FDA will continue these programs. In addition, FDA’s new export certification program for foods is intended to be complementary to export certification for foods currently issued by other U.S. government agencies.

FDA Issues Statement Regarding Labeling Coffee as a Carcinogen Consistent with California Proposition 65

  • California Proposition 65 requires manufacturers to provide clear and reasonable warnings to consumers before exposing them to over 950 listed carcinogens, including acrylamide.  As reported in this blog yesterday, California’s regulations for reporting the presence of the carcinogens have changed.  Also as previously reported in this blog, producers of roasted coffee have been sued under Proposition 65 for failing to declare the presence of acrylamide in coffee.  In June, California’s Office of Environmental Health Hazard Assessment (OEHAA) proposed a regulation that would exempt coffee from required Proposition 65 warnings, based on an extensive scientific review of coffee’s health effects.
  • On August 29, FDA issued a statement supporting California’s decision to exempt coffee from the required Proposition 65 warning for acrylamide.  In the statement, FDA Commissioner Scott Gottlieb, M.D., noted that FDA has the authority to regulate the labeling of food to prevent statements that are false or misleading in any particular.  Of particular note, the statement reads, “if a state law purports to require food labeling to include a false or misleading statement, the FDA may decide to step in.”
  • FDA’s position is that state labeling requirements for products regulated by FDA can be preempted by FDA regulation if the labeling requirement is inconsistent with FDA requirements.  Inportantly, FDA extends this argument to labeling statements that, upon scientific scrutiny, are determined to be false or misleading.  Dr. Gottlieb’s statement is consistent with the Accurate Labels Act, which many believe would eviscerate Proposition 65.  Manufacturers of FDA regulated products may now have more success raising FDA labeling requirements as a defense against state mandated warnings that are not supported by the weight of scientific evidence.

New Proposition 65 Warning Regulations Take Effect Today

  • As previously reported on this blog, in 2016 California passed new regulations redefining what makes a warning “clear and reasonable” under Proposition 65; those regulations become effective today.  Proposition 65 is a right-to-know law that requires manufacturers to provide a clear and reasonable warning to consumers before exposing them to over 950 listed carcinogens and reproductive toxicants.
  • Importantly, the new regulations do not impact the scope of the duty to warn.  If a manufacturer had no duty to warn before today, it would not be under a burden to warn in light of the new regulations.  Rather, the new regulations change the content and distribution of warnings, when required.  Some new features include:
    • Requiring a warning symbol to precede Proposition 65 warnings (except for warnings on foods);
    • Changing the wording of the warning to state “This product can expose you to” rather than “This product contains;”
    • Requiring the disclosure of the identity of at least one chemical per toxicity endpoint in the warning;
    • Including a link to the “Lead Agency Website” (www.P65Warnings.ca.gov) that offers additional information on Proposition 65 and listed chemicals;
    • Providing the option of a short form warning (subject to minimum type size requirements) when providing the warning on the product or its immediate container;
    • Requiring warnings for internet and catalog sales;
    • Requiring warnings in foreign languages if other “consumer information” is provided in foreign languages.
  • The new warnings also include specific warning language for specific types of consumer products and exposures, including for foods.  The new standard warning for food (which would need to appear in a bordered box) for a food containing at least one listed carcinogen and one listed reproductive toxicant would state:

Consuming this product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer and [name of one or more chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov/food.

  • California issued guidance indicating that products manufactured before August 30, 2018 can continue to bear warnings using the old format and continue to enjoy safe harbor protection; however, products requiring a warning that are manufactured on or after today must bear a warning using the new format.
  • Keller and Heckman LLP attorneys actively advise clients on compliance issues and enforcement actions related to California’s Proposition 65. If you have any questions about the implications of the new warning requirements or other related issues, please email prop65@khlaw.com.

California Passed Nation’s First Kids’ Meal Bill

  • In another effort to limit consumption of sugary drinks, California passed Senate Bill 1192, the nation’s first statewide kids’ meal bill. The bill requires that water, sparkling water, flavored water, unflavored milk, or a nondairy milk alternative are the default beverage in kids’ meals, instead of soda or other sugar sweetened beverages. The bill does not prohibit the sale of other drinks (e.g., soda), but only requires that the default beverage offered with the kids’ meal be water, milk, or a nondairy alternative. In addition, the default drinks must be featured on menus or in advertisements instead of the other drink choices, like soda.
  • California passed the measure as a means to combat the obesity epidemic. The legislature found that “many families lack adequate time to obtain and prepare healthy food, making dining out an appealing and often necessary option. As a result, more than one-half of food expenditures in the United States are spent outside the home. Nationwide, American children eat 25 percent of their calories at fast food and other restaurants. Children consume almost twice as many calories when they eat a meal at a restaurant as they do when they eat at home.” The California legislature stated that they passed the bill with the intent to support parents’ efforts to feed their children nutritiously.
  • Several fast food brands have already committed to changing their default beverage choices in kids’ meals, dating back to 2013. McDonald’s, Wendy’s, Burger King, Dairy Queen, IHOP, Applebee’s, and Jack in the Box all offer at least milk or water to children. And now with the passage of this bill, all California restaurants that offer kids’ meals will be required to follow suit and change their default beverage choices.
  • Similar to the popularity of soda taxes, kids’ meal bills are gaining momentum nationwide. According to the Center for Science in the Public Interest, nine California jurisdictions have already passed kids’ meal policies, and other cities and states across the country, like Baltimore, Louisville, New York City, Hawaii, and Vermont, are considering similar measures.

GFI and Others Sue Missouri over Plant-Based and Clean Meat Labeling Law

  • The Good Food Institute (GFI), the Animal Legal Defense Fund, the American Civil Liberties Union of Missouri, and Turtle Island Foods (Tofurky brand) sued the state of Missouri over a new law, Mo. Rev. Stat. § 265.494(7), which prohibits labeling a product that is not derived from harvested production livestock or poultry as meat. The plaintiffs requested both a preliminary injunction and a permanent injunction preventing enforcement of the Statute, in addition to a declaration that the Statute is unconstitutional and attorneys’ fees.
  • By way of background, the Missouri House approved House Committee Bill 16 in April 2018, which would have banned companies from labeling lab-grown meat products or meat substitutes as meat (see our May 1, 2018, blog). While that bill died in a senate committee, a provision that prohibits “misrepresenting” a product that does not come from a slaughtered animal as “meat” was added to an omnibus bill. Missouri Senate Bills 627 & 925 were signed by the governor in June 2018 and are scheduled to take effect today, Aug. 28. A violation of the law can result in incarceration up to one year and a fine of up to $1,000.
  • In the lawsuit, filed in the U.S. District Court for the Western District of Missouri, the plaintiffs argue that, “the Statute is a content-based, overbroad, and vague criminal law that prevents the sharing of truthful information and impedes competition by plant-based and clean-meat companies in the marketplace.” Furthermore, they claim that the Statute does not protect the public from potentially misleading information and, therefore, violates the Free Speech Clause of the First Amendment.
  • The aim of the Statue, according to the plaintiffs, is to protect the animal agriculture industry from competition from plant-based meat and clean meat producers. The lawsuit mentions that Tofurky fears prosecution under the Statute since its labels include terms that are also applied to conventional meat, like “kielbasa,” “hot dogs,” “ham roast,” “burgers,” and “bologna.” The Missouri Cattlemen’s Association, which supported the Statute, said its concern isn’t with products like Tofurky that make clear that they are from plants but with how meat grown by culturing animals cells will be labeled (National Post).
  • While clean meat (muscle tissue cultured in vitro from animal cells) is not yet commercially available, debates are taking place on how to regulate it. As we mentioned in a previous blog, the United States Cattlemen’s Association submitted a petition asking USDA to exclude cultured products from the definition of beef and meat. Missouri is the first state to address this issue. We will continue to report on regulatory activity in this area.

FDA Recognizes a Fourth Accreditation Body Under FSMA’s VQIP


  • As previously covered on this blog, the Food Safety Modernization Act (FSMA) established the Voluntary Qualified Importer Program (VQIP) for expediting the review and import entry of human and animal foods into the United States.  Certification through FDA’s Accredited Third-Party Certification Program is one of the eligibility criteria for participation in the VQIP.  Under the VQIP, certification bodies (1) conduct consultative and/or regulatory food safety audits and (2) issue certifications to eligible entities that produce food for humans and animals.  Aside from certifications issued for participation in the VQIP, which is fee-based and completely voluntary, certification may be required by FDA as a condition of entry for imported food products in limited circumstances when specific, risk-based criteria are met.
  • Third-party “certification bodies,” otherwise known as third-party auditors, must be recognized by accreditation bodies before they can issue certifications under the Accredited Third-Party Certification Program.  Accreditation bodies, in turn, must apply for and receive recognition from FDA before they may accredit certification bodies.  FDA announced the recognition of International Accreditation Services, Inc. (IAS) of Brea, California as an accreditation body in an August 23, 2018 constituent update.
  • As can be seen on FDA’s Public Registry of Recognized Accreditation Bodies, IAS is only the fourth accreditation body recognized so far under the Accredited Third-Party Certification Program.  IAS joins ANSI-ASQ National Accreditation Board (ANAB), the American National Standards Institute (ANSI), and the National Bureau of Agricultural Commodity and Food Standards (ACFS) which were recognized – with more limited scopes of authority – earlier this year.  IAS is currently the only recognized accreditation body whose scope of authority includes FDA’s regulations on Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers (LACF) and Acidified Foods.  IAS and some of the other three FDA-recognized accreditation bodies have the ability to recognize certification bodies for conducting food safety audits under FDA’s Current Good Manufacturing Practice, Hazard Analysis and Risk Based Preventive Controls for Human Food (Preventive Controls for Human Food rule), Current Good Manufacturing Practice, Hazard Analysis and Risk Based Preventive Controls for Animal Food (Preventive Controls for Animal Food rule), Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption (Produce Safety Rule), Hazard Analysis and Critical Control Point (HACCP) Systems (Juice HACCP), and Fish and Fishery Products (Seafood HACCP).


Please feel free to contact Keller and Heckman at fooddrug@khlaw.com with any questions about the VQIP.

FDA Extends Deadline for Comments on Nutrition Innovation Strategy

  • At the National Food Policy Conference in March 2018, FDA Commissioner Scott Gottlieb, M.D., announced the creation of the Nutrition Innovation Strategy (NIS).  The NIS is intended to improve public health by educating consumers and encourage innovation to expand the use of nutrition in reducing the instances and impact of chronic disease.  FDA held a public meeting on July 26, 2018 to discuss and solicit public input regarding the NIS.  The Daily Intake has previously published posts regarding the NIS here and here.  Keller and Heckman also published a client alert regarding the meeting.
  • Topics of discussion during the meeting included modernizing the approach to label claims, modernizing standards of identity (including for milk and dairy products), modernizing ingredient labels, and healthy symbols.
  • In the announcement for the July 26 meeting, FDA provided an opportunity for public comment until August 27, 2018.  In response to multiple requests for a longer comment period, FDA has extended the comment period until October 11, 2018.

We and our analytics and advertising providers may use cookies and similar technologies to enhance the browsing experience, facilitate sharing of content, and generate statistics about use of the website. For more information or to change your preferences, click here.

I Agree