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Industry News and Press: Regulatory Updates

August-September 2018 Regulatory Update

Sunday, September 30, 2018   (0 Comments)
These Regulatory Updates are brought to you by Michael Best & Friedrich. 

This Regulatory Update includes information from August 2018 through September 2018.  Please contact Seth Mailhot, Leah Ziemba, or Emily Lyons for additional information on regulatory issues that may impact upon your business. Special thanks to associate Taylor Fritsch and summer associate Jecoliah Williams for their assistance in putting together this update. 

The August-September 2018 Regulatory Update includes:

  • USDA and FDA to Hold Joint Meeting on Animal Cell Culture Technology
  • FDA’s New Export Certificate Program; USDA Codex Program Meeting (MUST-READ)
  • FDA Issues Draft Guidance on Dietary Supplements Containing Live Microbes; 
  • FDA Issues Warning About Food Prepared with Liquid Nitrogen
  • FDA Supports Exempting Coffee from Prop 65 Warnings
  • FDA Accepting Comments Associated with Voluntary Labeling Guidance on GMO Plants  (MUST-READ)
  • Food Safety Modernization Act Updates, and Other Developments of Interest



USDA and FDA to Hold Joint Meeting on Animal Cell Culture Technology 

The USDA’s Food Safety and Inspection Service (FSIS) and FDA will host a joint public meeting in Washington, DC on October 23–24, 2018 to discuss the use of cell culture technology to develop products derived from livestock and poultry. The first day of the meeting will focus primarily on the potential hazards that need to be controlled for the safe production of animal cell cultured food products, as well as oversight considerations by regulatory agencies. The second day of the meeting will focus on how to label these products. 

Individuals interested in attending the meeting in-person are encouraged to pre-register on the FSIS website. Anyone who wishes to submit written comments prior to or following the meeting may do so by submitting comments on by November 26, 2018. 

Comments submitted to FDA in the July 12, 2018 public meeting will also be considered.

>>Learn more 

FDA’s New Export Certificate Program 

The FDA has announced a new export certification program applicable to certain FDA-regulated food products, as well as fees to be assessed for issuing new export certifications to U.S.-based manufacturers or exporters of these products. Affected products include food for human consumption, with the exception of dietary supplements, medical foods, and foods for special dietary use. FDA will continue to issue the current "Certificate of Free Sale” for dietary supplements, medical foods, and foods for special dietary uses.

FDA expects the 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. Further, this export certification program is intended to be complementary to export certification for foods currently issued by other U.S. government agencies, such as those issued by USDA. 

FDA will issue and collect fees starting Oct 1, 2018.  See the Federal Register Notice here.

>>Learn more

USDA Codex Program Meeting 

The U.S. Codex Program public meeting in Washington, DC on September 26, 2018 to provide information and receive public comments on agenda and draft U.S. positions for the 24th Session of the Committee on Food Import and Export Inspection and Certification Systems (CCFICS) of the Codex Alimentarius Commission in Brisbane, Australia, Oct. 2018.  This committee develops principals and guidelines for food import and export inspection and certifications to harmonize methods and procedures which protect the health of consumers, ensure fair trading practices and facilitate international trade in foodstuffs.

The U.S. Codex Program will hold public meetings in Oct-Nov for Codex subsidiary body meetings:

  • Codex Committee on Food Hygiene in November 2018
  • Codex Committee on Nutrition and Foods for Special Dietary Uses in November 2018
  • Ad hoc Codex Intergovernmental Task Force on Antimicrobial Resistance in December 2018
  • Codex Committee on Spices and Culinary Herbs in January 2019. 

If attending the Sept. meeting, register to by emailing by Sept. 22 Attendees who wish to participate, may do so by phone/conference call.  More information about the call in option submit to Mary Stanley, U.S. Delegate to the 24th Session of the CCFICS

>>Documents from the 24th Session of CCFICS

>>USDA news bulletin

FDA Issues Draft Guidance on Dietary Supplements Containing Live Microbes 

On September 7, 2018 FDA released draft guidance for industry entitled "Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials.” The purpose is to advise firms that manufacture, market, or distribute dietary supplements of FDA's intent to exercise enforcement discretion if a firm wishes to specify the amount of a live microbial in colony forming units (CFUs) in addition to the currently required unit of measure (milligrams) in the Supplement Facts label. 

Under existing law, dietary supplements are permitted to bear information about the quantitative amount of live microbial dietary ingredients in CFUs in areas of the dietary supplement label outside of the Supplement Facts label, as long as this information is not false or misleading. However, within the Supplement Facts label itself, these ingredients can be quantified only by weight. 

Comments on the draft guidance open until Nov 6, 2018.  View the Federal Register Notice here.

FDA Issues Warning About Food Prepared with Liquid Nitrogen 

The FDA has issued a warning advising consumers and retailers of the potential for serious injury from eating, drinking, or handling food products prepared by adding liquid nitrogen at the point of sale (immediately before consumption). Such products may be sold as novelty items in malls, kiosks, and fairs, are often marketed as "Dragon’s Breath” and other similar names.  

FDA issued the safety alert after becoming aware of severe injuries such as damage to skin and internal organs caused by liquid nitrogen still present in the food or drink. There had also been reports of difficulty breathing after inhaling the vapor released by liquid nitrogen when added immediately before consumption. Individuals who have experienced an injury because of handling or eating products prepared with liquid nitrogen at the point of sale should contact a health care professional.

Learn more about these products and FDA’s reaction in Michael Best’s Client Alert.

FDA Supports Exempting Coffee from Prop 65 Warnings 

In a recent statement, FDA Commissioner Scott Gottlieb, M.D., stated that that the most current research on coffee and cancer does not support a cancer warning for coffee under California’s Proposition 65 based on the presence of acrylamide. Accordingly, Commissioner Gottlieb expressed strong support for a recent proposal by the California Office of Environmental Health Hazard Assessment (OEHHA) to exempt coffee from a Prop 65 cancer warning.

>>Learn more

FDA Solicits Comments on Voluntary Labeling Guidance on GMO Plants 

FDA is soliciting comments on information collection regarding guidance for food manufacturers who wish to voluntarily label their foods as being made with or without bioengineering, or the use of bioengineered ingredients. FDA seeks information about the perceived effectiveness of messages, advertisements, and materials in reaching and successfully communicating with their intended audiences, as well as the burdens associated with records to substantiate labeling claims are truthful and not misleading.  

Food companies have until October 9, 2018 to provide FDA with information.

View the Federal Register Notice here



FDA Issues Two New Food Facility Registration Guidance Documents 

In August 2018, the FDA issued two guidance documents to assist food facilities when completing their bi-annual registration. The first document, a final guidance for industry entitled "Questions and Answers Regarding Food Facility Registration (Seventh Edition),” provides updated information relating to the food facility registration requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act). View the guidance here

The second document, a draft guidance entitled "Supplemental Questions and Answers Regarding Food Facility Registration,” is intended to supplement the final Questions and Answers Regarding Food Facility Registration document. FDA issued this supplement because the agency continues to receive questions that highlight the need to provide guidance on registration requirements in situations where multiple entities are involved in the use of shared physical space, such as where one entity owns a building and lessees manufacture/process, pack or hold food in the building. View the guidance here. FDA will accept comments on the draft guidance until October 19, 2018.

As a reminder, food facilities are required to register with FDA every even numbered year.  

The registration period is open from October 1, 2018 to December 31, 2018, and can be completed here on the FDA website



USDA Announces Nominations Now Open for the 2020 Dietary Guidelines Advisory Committee

On September 5, 2018, USDA announced a public call for nominations to the 2020 Dietary Guidelines Advisory Committee (DGAC). The independent advisory committee will review the scientific evidence to help inform the next edition of the Dietary Guidelines for Americans. These guidelines are used to inform the development of federal food, nutrition, and health policies and programs. 

The next edition of the guidelines will take a life stage approach, including pregnant women and children from birth to 24 months as mandated by the 2014 Farm Bill. The scientific review will reflect earlier public comments and focus on eating/drinking patterns to help prevent disease and keep people healthy. The government is seeking nominations that reflect expertise related to these areas.

The deadline to submit nominations for the DGAC is October 6, 2018, at 11:59 pm, EST.

>>USDA announcement

USDA Names Policy Advisor for Food and Nutrition Service (FNS)

Sept 5, 2018, Secretary of Agriculture Sonny Perdue named Pamilyn Miller as the USDA Food and Nutrition Service (FNS) senior associate administrator for policy. Miller has served on both the House Agriculture Committee and the House Appropriations Committee, focusing on nutrition policy and funding. 

>>USDA announcement

USDA Sends Bioengineered (BE) Food Disclosure Final Regulation Standard

USDA sent the final regulation to implement the National Bioengineered Food Disclosure Standard to the White House for review last month; represents the penultimate step in finalizing the standard, which will introduce mandatory labeling rules for BE foods or foods with BE ingredients.  Information on the status can be found on White House website.

FDA Extends Comment Period for Nutrition Innovation Strategy Comments 

FDA is extending comment period on "FDA’s Comprehensive, Multi-Year Nutrition Innovation Strategy.”   

FDA will accept comments until October 11, 2018. View the Federal Register Notice here.

USDA:  FSIS Extends Comment Period for Petition of "Product of USA” Labeling Claim

FSIS has announced that it will accept public comments until September 17, 2018 on a petition requesting that FSIS change the labeling requirements for "Product of U.S.A.” in the FSIS Food Standards and Labeling Policy Book.

>>USDA announcement

FDA Issues Statement on Updated Approach to Added Sugar Labeling for Maple Syrup and Honey

In a recent statement, FDA Commissioner Scott Gottlieb, M.D., announced that FDA anticipates issuing new guidance regarding the added sugars declaration on the label of pure, single-ingredient "packaged as such” products like maple syrup and honey by early next year. The statement also explains that FDA will still require the percent daily value for these products, but will the use of an obelisk symbol, "†,” immediately after the added sugars percent daily value information on containers of pure maple syrup or pure honey to direct consumers to language that provides information about what "added sugars” actually mean for these specific products.   

>>Learn more


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