May–June 2019 Regulatory Update

These Regulatory Updates are brought to you by Michael Best & Friedrich. 
This Regulatory Update includes information from May 15 through June 21, 2019. Please contact Leah ZiembaPaul Benson, or Taylor Fritsch for additional information on regulatory issues that may impact your business.

The May-June 2019 Regulatory Update includes several MUST READ updates: 

FDA AND USDA UPDATES

  • FDA Releases Guidance on the Declaration of Added Sugars on Honey, Maple Syrup, Other Single-Ingredient Sugars, and Certain Cranberry Products (MUST READ)

  • FDA Issues Draft Guidance for Reducing Food Safety Hazards in the Production of Seed for Sprouting 

  • FDA Supports Industry Collaboration to Reduce Confusion over Date Labels (MUST READ)

  • FDA Blog Discusses Agency Approach to CBD Products

 

FOOD SAFETY MODERNIZATION ACT (FSMA) UPDATES

  • FDA Releases Guidance for Determining the Number of Employees for Purposes of the “Small Business” Definition in the FSMA Preventive Controls for Human and Animal Food Rules (MUST READ)

  • FDA Releases Draft Guidance on Evaluating Alternate Curricula for Food Safety Training under the Produce Safety Rule (MUST READ)

OTHER DEVELOPMENTS OF INTEREST

• FDA Settles Suit, Agrees to Propose List of “High-Risk” Foods Next Year (MUST READ)

• Check it Out: Social Media Toolkit for Consumer Outreach on Menu Calorie Labeling


FDA AND USDA UPDATES

 FDA Releases Guidance on the Declaration of Added Sugars on Honey, Maple Syrup, Other Single-Ingredient Sugars, and Certain Cranberry Products

In mid-June, the FDA announced the availability of a guidance document providing clarity on the labeling of added sugars for single-ingredient packages or containers of pure honey, maple syrup and other single-ingredient sugars and syrups. Under the final guidance, these single-ingredient products are not required to declare the number of grams of added sugars in a serving of the product on the Nutrition Facts label but must still include the percent Daily Value for added sugars to ensure that consumers have information about how a serving of these products contributes to their total diet. The final guidance also provides information about how to label certain cranberry products with the “Added Sugars” label.

In a statement, the FDA said that this guidance is a way to provide consumer with “information as to how consumption of these products can be accommodated within the recommendations of the dietary guidelines, while at the same time reducing the potential for consumers to misinterpret single-ingredient sugars and syrups as having additional sugars in them.”

FDA will exercise enforcement discretion to ensure that manufacturers have time to redesign their packaging and adhere to the new requirements. Manufacturers of these products will have until July 1, 2021 to comply with the Nutrition Facts label and serving size rules issued in 2016. 

Read the guidance

 

FDA Issues Draft Guidance for Reducing Food Safety Hazards in the Production of Seed for Sprouting

In draft guidance released in late June, the FDA announced its intention to provide recommendations to those in the sprout seed industry to help reduce outbreaks of foodborne illness associated with the consumption of raw and lightly-cooked sprouts. The FDA recommends that seed for sprout production be grown using good agricultural practices (GAPs) or in conformance with international standards. The draft guidance also recommends that all firms in the sprout seed supply chain take steps to reduce microbial food safety hazards in seed for sprouting.

To ensure consideration by the agency, comments on the draft guidance must be submitted by August 26, 2019.

Read the draft guidance

 

FDA Supports Industry Collaboration to Reduce Confusion over Date Labels

In late May, the FDA issued a letter to the food industry supporting efforts to standardize voluntary date labeling if the date is simply used for quality—not safety. The FDA strongly supports the use of the introductory phrase “Best If Used By” when applying a quality date label, as research has shown that this specific phrasing “helps consumers understand that the date label is about quality, not safety, and that products do not have to be discarded after the date if they are stored properly.”

Read more

 

FDA Blog Discusses Agency Approach to CBD Products

After a May 31, 2019 public meeting on CBD, senior FDA officials released a lengthy blog post concerning the agency’s regulatory approach to CBD. Recognizing the significant public interest in CBD products, the agency acknowledged that FDA’s authority “is becoming more practically relevant.” Some highlights:

  • FDA stated that it is “currently illegal to put into interstate commerce a food to which CBD has been added, or to market CBD as, or in, a dietary supplement.” This is because CBD was the subject of “substantial clinical investigations into its potential medical uses before it was added to foods (including dietary supplements)” and because CBD is the active ingredient in an FDA-approved prescription drug—Epidiolex.
  • FDA acknowledged the public interest in marketing and accessing CBD in food and its potential benefits but stated that “questions remain regarding its safety.” The agency specifically highlighted “unanswered questions” about CBD product use outside of the approved drug context, such as how much CBD can be safely consumed in a day and risks of long-term exposure. The agency also called out its particular concern with CBD products that make unsubstantiated therapeutic claims.
  • FDA is “exploring potential pathways for various types of CBD products to be lawfully marketed,” including in the “non-drug” context, but doesn’t seem keen on doing so without a science-driven process that addresses safety concerns.

The agency is taking written comments on its regulatory approach to CBD until July 16, 2019.

Read the blog here


 

FOOD SAFETY MODERNIZATION ACT (FSMA) UPDATES

FDA Releases Guidance for Determining the Number of Employees for Purposes of the “Small Business” Definition in the FSMA Preventive Controls for Human and Animal Food Rules

In June, the FDA released guidance on determining the number of employees for purposes of the “small business” definition in the FSMA Preventive Controls for Human and Animal Food Rules. The guidance will help industry subject to these rules determine the number of employees for purposes of the “small business” definition.

Whether a business is a “small business” has two main implications. First, certain small businesses are exempt from the human food preventive controls requirements if they are engaged only in specified low-risk activity/food combinations. Second, small businesses have later compliance dates than larger businesses. This finalizes draft guidance dated March 2018.

Read the guidance

 

FDA Releases Draft Guidance on Evaluating Alternate Curricula for Food Safety Training under the Produce Safety Rule

In draft guidance released in early June, the FDA provided draft recommendations on factors that covered farms should consider if they are using an alternate curriculum training to meet food safety training requirements of the Produce Safety Rule and for educators when developing or evaluating alternate curricula.

To ensure consideration by the agency, comments on the draft guidance must be submitted by October 2, 2019.

Read the guidance

 

OTHER DEVELOPMENTS OF INTEREST

FDA Releases Results of Limited Testing of Foods for PFAS Substances

FDA recently released the results of a limited sampling of foods originally collected as part of the FDA’s Total Diet Study (TDS) in 2017 for per- and polyfluoroalkyl substances (PFAS). While no PFAS compounds were detected in the majority of the foods sampled, varying levels of PFAS were found in 14 of the 91 samples. FDA said that a safety assessment concluded that the products were not likely to be a health concern at the levels detected. “Overall, our findings did not detect PFAS in the vast majority of the foods tested. In addition, based on the best available current science, the FDA does not have any indication that these substances are a human health concern, in other words a food safety risk in human food, at the levels found in this limited sampling. These data give our scientists a benchmark to use as we continue our critical work studying this emerging area of science,” FDA officials said in a statement.

 

FDA Settles Suit, Agrees to Propose List of “High-Risk” Foods Next Year

To resolve a lawsuit brought by the Center for Food Safety and Center for Environmental Health, FDA has agreed to develop a list of “high-risk” foods and create new record-keeping requirements for some companies that handle those foods. Under a consent decree entered by a federal court in California, FDA agreed to file a proposed rule by September 2020 and a final rule by November 2022. The plaintiffs in the case alleged that FDA drug its heels on issuing the rules, required under Section 204 of FSMA, and failed to meet required deadlines.

Read the consent decree

 

Check it Out: Social Media Toolkit for Consumer Outreach on Menu Calorie Labeling

The FDA is making available a Menu Labeling Social Media Toolkit for use by organizations and health education professionals to conduct outreach with their audiences. The toolkit is “designed to raise awareness of how consumers can use calorie information they may now see on menus and menu boards.”

Read FDA’s update

 

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