FDA proposes e-filing requirements to facilitate product imports.

  • FDA and the U.S. Customs and Border Protection Agency (CBP) work together to facilitate the admission of imported products into the U.S.  The Automated Commercial Environment (ACE) is a commercial trade processing system operated by CBP that helps automate and expedite the processing of imports and exports.
  • Earlier this month, FDA issued a proposed rule to establish requirements for the electronic filing of FDA-regulated products in ACE (or any CBP-authorized electronic filing system).  The proposed rule would require certain data elements to be submitted at the time of entry, with such elements falling generally into two categories:  (1) those that identify the article offered for import; and (2) those that identify the person(s) seeking to import the article.  The proposed rule would impose submission requirements related to the importation of foods, food-contact substances, and other FDA-regulated products.
  • FDA’s stated goal is for these requirements to facilitate effective and efficient admissibility review by the Agency and an improved ability to focus FDA’s limited resources on higher-risk imports.  Interested stakeholders are invited to submit comments on the proposed rule by August 30, 2016.

FDA releases Foods and Veterinary Medicine (FVM) program’s future plans.

  • FDA’s Foods and Veterinary Medicine (FVM) program encompasses the Office of Foods and Veterinary Medicine (OFVM), the Center for Food Safety and Applied Nutrition (CFSAN), and the Center for Veterinary Medicine (CVM), as well as related activities under the Office of Global Regulatory Operations and Policy and the Office of Regulatory Affairs (GO/ORA).
  • On July 14, 2016, FDA released the FVM’s Strategic Plan for the next 10 years (FY 2016-2025), organized under four key goals:  (1) food safety; (2) nutrition; (3) animal health; and (4) organizational excellence.  As guiding principles, the Strategic Plan puts first priority on public health and notes the importance of partnerships, scientific expertise and research, and transparency.
  • The Strategic Plan imposes no immediate obligations on the food industry, but interested stakeholders may wish to peruse the Plan to get a sense of the Agency’s future directions and longer-term operational goals.

FDA approves increase in vitamin D added to milk and approves addition to milk alternatives.

  • Many substances added directly to food in the U.S. are marketed on the basis of FDA food additive regulations, which are located in 21 CFR Part 172.  By law, FDA may approve the use of a food additive only after conducting a scientific safety review of the information provided in a food additive petition to ensure that use of ingredients added to foods are safe for the general population.
  • In response to a food additive petition, FDA has amended the food additive regulations to expand the safe uses of vitamin D2 as a nutrient supplement in edible plant-based milk alternative beverages (e.g., soymilk) and in edible plant-based yogurt alternatives.  The amended regulations also will permit the use of vitamin D3 as a nutrient supplement in milk at levels higher than those permitted in the past.
  • Vitamin D helps with the absorption of calcium and phosphorus in the small intestine and is essential for human health.  The amended FDA regulations will allow manufacturers to voluntarily add up to 84 IU/100g of vitamin D3 to milk, 84 IU/100g of vitamin D2 to plant-based beverages intended as milk alternatives, and 89 IU/100g of vitamin D2 to plant-based yogurt alternatives.  Manufacturers may begin using the new amounts on July 18, 2016.

Federal GM labeling compromise awaits presidential signature.

In an update on a topic frequently covered in recent weeks on this blog, the Senate compromise bill to establish a federal standard for the labeling of genetically modified (GM) foods gained bipartisan support in the House of Representatives and passed with a 306-117 vote on July 14, 2016.  Assuming that President Obama signs the bill into law, Vermont’s GM requirements will be pre-empted and implementation of a more flexible federal GM labeling standard will begin.

Keller and Heckman LLP will be analyzing the compromise legislation and summarizing its implications for the food industry.

FDA amends food facility registration requirements.

  • Under Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. must register with FDA.  The registration requirement has been in effect since 2003.  However, the FDA Food Safety Modernization Act (FSMA) added new provisions to the FD&C Act related to the registration of food facilities.
  • On July 14, 2016, FDA published a final rule to amend the facility registration requirements as part of its FSMA implementation strategy.  The amended regulations codify the following new requirements (which were self-implementing and became effective upon FSMA’s enactment):
    • Domestic facility registrations must contain the email address for the contact person of the facility
    • Foreign facility registrations must contain the email address of the U.S. agent for the facility
    • Food facilities must renew their registrations with FDA every 2 years, between October 1 and December 31 of each even-numbered year
    • Facility registrations must contain an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act
  • The amended regulations also provide for the following:
    • Beginning on January 4, 2020, FDA will require all facility registrations to be submitted in an electronic format
    • Registrants may submit a written request for a waiver to FDA explaining why it is not reasonable to submit the registration, registration renewal, or cancellation to FDA electronically or to explain why it is not reasonable to provide requisite email address contact information
    • The definition of the term “retail food establishment” (exempt from registration) is revised to expressly state that certain types of direct sales (including sales at roadside stands, farmers’ markets, and via community-supported agriculture programs) count toward demonstrating the primary function of such establishments
    • Registrations must include activity types performed with respect to each food product category being handled at the facility
    • An abbreviated registration renewal process is now codified for registrations that do not have any changes to the required information since submission of the preceding registration or renewal
  • Finally, in upgrades intended to improve FDA’s food facility registration database:
    • Additional data elements will newly be required in food facility registrations (e.g., beginning October 1, 2020, facilities must submit a unique facility identifier (UFI) acceptable to FDA, which may be a D-U-N-S number)
    • Measures will be employed to verify certain information submitted in registrations
    • Additional steps will be taken to ensure that the registration database is up-to-date by identifying circumstances under which FDA will cancel registrations
  • With the limited exception of certain clarifications relevant to the “retail food establishment” exemption, the final rule does not materially alter the scope of FDA’s registration requirement.  Food industry stakeholders required to register with FDA should review and familiarize themselves with the newly-revised registration requirements and their potential impact on food facilities.

Vermont AG provides online complaint form to permit reporting of possible GM labeling violations. 

  • As the food industry is well aware, Vermont’s labeling requirements for genetically modified (GM) foods took effect on July 1, 2016.  However, there is a limited 6-month “safe harbor” provision between July 1 and December 31, 2016 during which the Vermont Attorney General (AG) will not take action unless there is evidence that a manufacturer distributed a mislabeled product after the July 1 effective date.
  • In the meantime, the AG’s office has developed and released an online complaint form for consumers to report possible labeling violations.  The online complaint portal indicates that complaints will be forwarded to manufacturers and/or retailers selling the food product(s) at issue.  At this early stage, it is not clear whether or how the AG or consumers can know which food products properly fall within the “safe harbor” exemption.
  • Stakeholders continue to await the outcome of Congressional votes on the recently-brokered bipartisan GM labeling deal that would pre-empt Vermont’s law and establish a federal labeling standard in this area.

FSIS to release establishment-specific data for public review.

  • The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has jurisdiction over meat, poultry, and egg products in the U.S.  FSIS employs thousands of food safety inspectors who evaluate products in facilities across the nation and at ports of entry into the U.S.
  • FSIS has announced that it will begin quarterly releases of establishment-specific data to the public in accordance with the Agency’s Establishment-Specific Data Release Strategic Plan.  The quarterly releases initially will include information on the processes used at regulated establishments, as well as a code for each facility that will make it easier to sort and combine future data sets on a facility-specific basis.  FSIS also will release test results for Listeria monocytogenes and Salmonella in ready-to-eat foods.  Ultimately, the data sets will be expanded to include additional information such as results from pathogen testing (e.g., Salmonella and Campylobacter results in poultry) and routine chemical residue testing data.  FSIS has indicated its intent to use criteria such as data availability and potential impact on public health to determine which data are best suited for release.
  • The move for greater transparency is part of the Obama Administration’s “Open Government Plan,” and the data sets will be published on data.gov on a quarterly basis starting 90 days after publication in the Federal Register.

FDA to extend compliance date for vending machine labeling requirements.

  • In December 2014, FDA published a final rule to require calorie declarations for foods sold in vending machines.  Under the rule, calorie declarations must be clear, conspicuous, and prominently placed so that a prospective purchaser may easily read such information prior to making a purchase.  Although front-of-pack (FOP) calorie declarations may meet the rule’s requirements, the declaration:  (1) must represent the total number of calories in the package as sold in the vending machine (e.g., “per serving” declarations alone are insufficient); and (2) must appear in a type size 50 percent of the largest printed matter on the label.  Although many foods already bore FOP label statements prior to the rule’s issuance, the new rule posed technical challenges for many products.  FDA initially stated that the compliance date for the vending machine requirements was December 1, 2016.
  • On July 8, 2016, FDA announced its intent to extend 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:  (1) foods sold from glass-front vending machines that have visible FOP labeling; and (2) certain gums, mints, and roll candy sold in vending machines.  The compliance date will remain December 1, 2016 for:  (1) packaged food sold in glass-front vending machines that does not have visible FOP labeling; (2) vending machines that use electronic displays; and (3) vending machines that sell unpackaged products.  In such cases, the calorie disclosures will have to appear in, on, or adjacent to the vending machine consistent with the requirements of the final rule.
  • FDA is granting the extension in response to requests from industry trade associations.  The Agency has stated that it recognizes the industry’s concerns about technical challenges associated with the FOP disclosure type size requirements and plans to issue a proposed rule for comment on this issue.  With respect to certain gums, mints, and roll candy, FDA has acknowledged the industry’s requests for flexibility but has not yet indicated potential alternative labeling approaches for these products.  The extension should be formally announced in the Federal Register in the near future.

FDA finalizes guidance on declaration of small amounts of nutrients and dietary ingredients on nutrition labels.

  • In August 2015, FDA issued a draft guidance document stating the Agency’s policy on the declaration of small amounts of nutrients and dietary ingredients on nutrition labels.  The draft guidance provided FDA’s recommendations on how to comply with nutrition labeling requirements in cases where the presence of small amounts of nutrients or dietary ingredients creates a conflict between applicable regulatory provisions.
  • FDA recently finalized its guidance on this topic, making only “editorial changes” to the draft, which include updates to the list of nutrients in 21 CFR 101.9(g)(4) and (g)(5), consistent with the recently-issued final rule revising the Nutrition and Supplement Facts labels.
  • For a more detailed summary on the contents of the “small amounts” guidance, click here.  (The alert covers the draft guidance, but as noted above, FDA made no substantive changes).

GMO labeling bill moves forward in the Senate.

  • As previously covered on this blog, on June 23, the Senate Agriculture Committee announced a bipartisan deal that would create a national labeling standard for genetically modified (GM) foods while pre-empting conflicting state laws, such as Vermont’s requirements (which took effect on July 1).  Sen. Bernie Sanders (I-Vermont) responded by placing a “hold” on the legislation by initiating a procedural maneuver that requires at least 60 votes for the bill even to be considered by the Senate
  • On July 6, the bill moved forward in a 65-32 vote and is now expected to gain final approval in the Senate as early as this week.  If enacted, the bill would require labeling of foods that “contain genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques” and has been modified in a way that could not be replicated through conventional breeding.
  • Now that Senate approval seems both likely and imminent, stakeholders are turning their eyes to the House, which voted in favor of voluntary labeling last year.  Companion legislation must be introduced in the House, receive a favorable vote, and be signed by President Obama before the long-awaited deal would become federal law.  It remains to be seen whether – and if so, when – these steps will take place.