April–May 2019 Regulatory Update

These Regulatory Updates are brought to you by Michael Best & Friedrich. 

This Regulatory Update includes information from April 6 through May 31, 2019.  Please contact Leah ZiembaPaul Benson, or Taylor Fritsch for additional information on regulatory issues that may impact your business. 

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

 

FDA AND USDA UPDATES

  • FDA Releases Draft Guidance on Initiating Voluntary Recalls (MUST READ)
  • FDA Will Exercise Enforcement Discretion Relating to Declaration of "Potassium Chloride Salt” as an Alternative to "Potassium Chloride” on Ingredient Statement (MUST READ)
  • FDA Clarifies its Enforcement Policy Against CBD Companies (MUST READ)
  • FSIS Proposes Eliminating "Dual Labeling” Requirement for Certain Packages of Meat and Poultry
  • FDA Draft Guidance Addresses How to Declare Allulose, a Sweetener, on the Nutrition Facts Label
  • FDA Taking Comments as Part of Dietary Supplement Regulatory Innovation Effort
  • Guidance Addresses Food Contact Substances Used in Contact with Infant Formula and/or Human Milk

FOOD SAFETY MODERNIZATION ACT (FSMA) UPDATES

  • Inspections under FSMA Intentional Adulteration Rule Will Begin in March 2020 (MUST READ)
  • FDA Extends VQIP Application Deadline

OTHER DEVELOPMENTS OF INTEREST

  • FDA Releases Results of Inspections, Environmental Sampling at Ice Cream Production Facilities
  • CBD Beer and Wine Might Have to Wait
  • FDA Sampling Frozen Berries for Harmful Viruses
  • Coalition of Food Industry and Health Advocates Encourage FDA Advancement of Sodium Reduction Targets
  • Study Concludes Added Sugar Label May Lead to Billions in Health Cost Savings

 

FDA AND USDA UPDATES

FDA Releases Draft Guidance on Initiating Voluntary Recalls

FDA released draft guidance for industry and agency staff regarding voluntary recalls under 21 CFR Part 7. Structured in a question-and-answer format, the draft guidance provides information on preparing for and initiating voluntary recalls. FDA’s recommendations relate to three main areas: training, recordkeeping, and recall procedures.

"We know that in order for a recall to be effective and timely, it’s crucial that companies be prepared in advance to take all necessary steps for when a recall is initiated. That’s why the FDA’s work is also keenly focused on guiding companies on steps needed to ready their facilities and staff for possible recall situations,” FDA associate commissioner Melinda K. Plaisier said.

To ensure consideration by the agency, comments on the draft guidance must be submitted by June 24, 2019.

Read the draft guidance

 

FDA Will Exercise Enforcement Discretion Relating to Declaration of "Potassium Chloride Salt” as an Alternative to "Potassium Chloride” on Ingredient Statement

In draft guidance released in May, FDA announced that it will exercise enforcement discretion to allow food manufacturers to use "potassium chloride salt” in place of the common or usual name "potassium chloride” on the ingredient statement. Potassium chloride is often used as a partial substitute for sodium chloride in food manufacturing. FDA notes that the substitution of potassium chloride for sodium chloride is advantageous from a nutrition or public health perspective, in light of the over-consumption of sodium and under-consumption of potassium.

The draft guidance determines that it is appropriate to allow the declaration of "potassium chloride salt” because this term "may help consumers to better understand the similarities between potassium chloride and sodium chloride with respect to taste and function” and is not likely to lead to consumer confusion.

To ensure consideration by the agency, comments on the draft guidance must be submitted by July 17, 2019.

Read the draft guidance

 

FDA Clarifies its Enforcement Policy Against CBD Companies

In mid-April, outgoing FDA chief Dr. Scott Gottlieb released a statement regarding FDA’s next steps to evaluate potential regulatory pathways for cannabis-containing and cannabis-derived products. Despite the 2018 Farm Bill, which removed hemp and its derivatives, like cannabidiol (CBD), from being a Schedule I Controlled Substance, the FDA continues to view the addition of CBD to food and beverage products or dietary supplements as a violation of the Food, Drug & Cosmetic Act. This is because CBD is considered a drug in the eyes of FDA after the agency approved a CBD drug, Epidiolex, to treat seizures in 2018, and the FDA does not allow drugs to be used in food and beverages or as dietary supplements under the Food, Drug and Cosmetics Act.

FDA’s statement confirms that the FDA will continue enforcement actions against CBD companies that make any treatment, health or disease claims (i.e., this product will cure or treat cancer) on a product or in marketing. FDA’s statement came at the same time it sent three warning letters to companies making what it called "egregious health claims,” and the FDA stated that it plans to "protect consumers from companies illegally selling CBD products that claim to prevent, diagnose, treat or cure serious diseases...”

Read more in Michael Best’s recent client alert

Read the FDA statement

 

FDA Taking Comments as Part of Dietary Supplement Regulatory Innovation Effort

In mid-May, FDA held a public meeting "seeking ideas for facilitating responsible innovation in the dietary supplement industry while preserving the FDA's ability to protect the public from unsafe, misbranded, or otherwise unlawful dietary supplements.” Stakeholders with responsive comments should submit them to the agency by July 15, 2019.

The announcement comes after FDA announced an effort to modernize regulation and oversight of dietary supplements for the first time in more than 25 years. Former FDA Commissioner Dr. Scott Gottlieb identified four "new steps” the agency would be taking to achieve its goals of "preserving consumers’ access to lawful supplements” and "protecting the public from unsafe and unlawful products,” including:

  • Communicating to the public as soon as possible when there is a concern about a dietary supplement on the market;
  • Ensuring that FDA’s regulatory framework is flexible enough to adequately evaluate product safety while also promoting innovation;
  • Continuing to work closely with industry;
  • Developing new enforcement strategies; and
  • Continuing to engage in a public dialogue to get valuable feedback from dietary supplement stakeholders.

Read more on FDA’s dietary supplement regulatory modernization effort

Submit comments on responsible innovation in dietary supplements

 

FSIS Proposes Eliminating "Dual Labeling” Requirement for Certain Packages of Meat and Poultry

USDA’s Food Safety and Inspection Service (FSIS) released a proposed rule eliminating provisions requiring packages of meat and poultry containing "at least one pound or one pint, but less than four pounds or one gallon, to express the net weight or contents in at least two different units of measurement on the product label.”

The action is being taken in response to a petition submitted on behalf of a small meat processing establishment. After review, FSIS determined that the requirement is not necessary to inform consumers as to the contents of the package. Comments will be accepted until June 17, 2019.

Read the proposed rule

 

FDA Draft Guidance Addresses How to Declare Allulose, a Sweetener, on the Nutrition Facts Label

Draft guidance issued by the FDA describes how calories, carbohydrates, total sugars, and added sugars for low-calorie sweetener allulose should be declared on the Nutrition Facts label. FDA’s guidance recognizes that allulose occurs naturally and is present in small amounts in wheat, fruits, and in other foods and can be manufactured and used as a sugar substitute in conventional foods and beverages.

The draft guidance announces FDA’s intention to exercise enforcement discretion allowing the exclusion of allulose from the amount of Total Sugars and Added Sugars declared on the Nutrition and Supplement Facts label pending future rulemaking. At the same time, the agency determined that allulose should still be included in the declaration of Total Carbohydrates on the Nutrition and Supplement Facts label.

The draft guidance also announces that the agency will exercise enforcement discretion for the use of a caloric value of 0.4 kcal/g for allulose (rather than the usual 4 kcal/g for carbohydrates), recognizing that the majority of allulose is excreted intact in urine.

To ensure consideration by the agency, comments on the draft guidance must be submitted by June 17, 2019.

Read the draft guidance

 

FDA Guidance Addresses Food Contact Substances Used in Contact with Infant Formula and/or Human Milk

New FDA guidance provides specific guidance to manufacturers submitting food contact notifications (FCNs) for food contact substances (FCSs) used in contact with infant formula or human breast milk. The guidance cites scientific advances in the fields of developmental biology and toxicology that have caused the agency to reevalute its approach to safety assessments for FCSs that contact infant food. According to FDA, the guidance "contains recommendations regarding how the scientific information in FCNs for infant food uses should demonstrate that the FCS is safe for the specific intended use.”

Read the guidance

 

FOOD SAFETY MODERNIZATION ACT (FSMA) UPDATES

Inspections under FSMA Intentional Adulteration Rule Will Begin in March 2020 (MUST READ)

In April, FDA announced that routine inspections to verify compliance with the FMSA Intentional Adulteration (IA) rule will begin in 2020.  Per FDA, the first compliance date for the IA Rule is July 26, 2019 for any business that averages equal to or more than $10 million (adjusted for inflation) per year, during the three-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee) AND that has more than 500 full-time equivalent employees.

"FDA has heard from stakeholders that due to the novel nature of the IA rule and its requirements, they believe more time is needed to develop a fully compliant food defense plan. We are working hard to provide resources, including the final portion of draft guidance, which may be helpful to industry,” FDA wrote.  "To allow industry time with the forthcoming materials, tools, and trainings, and because the IA rule represents new regulatory territory for all of us, we will be starting routine IA rule inspections in March 2020.” 

Read the announcement here

 

FDA Extends VQIP Application Deadline

In May, FDA announced that it is extending the application period for participation in the Fiscal Year 2020 benefits period for the Voluntary Qualified Importer Program (VQIP). VQIP is a voluntary, fee-based program established under FSMA. According to FDA, the program provides for expedited review and importation of human an animal foods for approved applicants. The new deadline is July 31, 2019 for the annual benefits period beginning October 1, 2019.

Read FDA’s update

 

OTHER DEVELOPMENTS OF INTEREST

FDA Releases Results of Inspections, Sampling at Ice Cream Production Facilities

In late April, FDA released the results of inspections and environmental sampling at ice cream production facilities conducted in 2016 and 2017. FDA’s surveillance involved 89 ice cream production facilities in 32 states, representing 16 percent of domestic ice cream manufacturers in FDA’s inventory. The agency detected Listeria monocytogenes in 21.3% of all establishments (19 of 89) but in just 1.25% of all sub-samples. Listeria was detected in just one sample involving a food contact surface, while all other detections involved non-food contact surfaces. Salmonella was detected in just one of the 89 facilities (1.1%) and in only one sub-sample (0.01%). As to inspection-based outcomes, FDA classified the facilities as follows:

  • No Action Indicated: 44 facilities (49.4%)
  • Voluntary Action Indicated: 39 facilities (43.8%)
  • Official Action Indicated: 6 facilities (6.7%)

Notably, FDA’s surveillance did not include testing of finished product for Listeria monocytogenes or Salmonella.

While the inspections were not conducted to assess compliance with the FSMA Preventive Controls for Human Food Rule, FDA wrote that "the findings underscore the need for the development and implementation of a food safety plan as required by the Preventive Controls rule.”

Read FDA’s Constituent Update

View the results

 

CBD Beer and Wine Might Have to Wait

The U.S. Alcohol, Tobacco, Tax and Trade Bureau (TTB) released an Industry Circular on April 29, 2019 clarifying the federal government’s position on the legality of adding cannabis-derived ingredients (hemp or marijuana) to alcoholic beverages. In short, don’t expect the TTB to approve cannabis derived substances like CBD or THC in alcoholic products any time soon.

 

FDA Sampling Frozen Berries for Harmful Viruses

FDA is nearly halfway through an 18-month effort to sample frozen berries for hepatitis A virus and norovirus. The sampling began in November 2018 and involves the collection of domestic samples of frozen berries in retail packaging from processors, distribution centers, warehouses, and retail locations.

Read the FDA’s update

 

Major Food Companies and Health Advocacy Groups Align on FDA Sodium Reduction Targets

In a letter to congressional leaders, a coalition including health advocacy NGOs and four major food companies (Nestlé, Unilever, Mars Inc. and Danone North America) signaled their support for voluntary sodium reduction targets. The letter urges Congress to remove an appropriations rider that blocked FDA from advancing longer-term sodium reduction targets. FDA proposed draft two-year and 10-year sodium reduction targets in 2016. In early April, the agency indicated that it is preparing to release sodium reduction targets in the coming months.

 

Study Concludes Added Sugar Label May Lead to Billions in Health Cost Savings

Results of a Tufts University modeling study published earlier this spring suggest that FDA’s mandatory added sugar label could save $31 billion in net healthcare costs and $61.9 billion in societal costs over a 20-year study period. The analysis estimates that the added sugar label could prevent or postpone nearly 1 million cases of cardiometabolic disease (including heart disease, stroke, and type 2 diabetes) over the study period.

Read the Tufts press release

 

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