FDA Shares Stakeholder Voices, Issues Guidance for Qualified Importers

In a significant milestone in the Food and Drug Administration’s implementation of FSMA, the agency is expected to issue a final rule next month on preventive controls for human and animal foods.

FDA released a series of videos on FSMA implementation last month featuring comments and insights from stakeholders and agency officials. Many of those speakers expressed the view – and I agree with them – that outreach and education by the agency will be the key to the successful implementation of the new requirements.

Also last month, FDA released draft guidance on the Voluntary Qualified Importer Program (VQIP) for importers of human or animal food, for companies that might become participants in the user-fee-funded program. The agency estimates that the annual fee would be approximately $16,400 for participation in the voluntary program.

The program would allow for expedited importation of food from importers who volunteer to participate. The draft guidance describes the eligibility criteria and also reviews what might cause VQIP eligibility to be revoked, as well as criteria for reinstatement. And it describes how the agency plans to set user fees to fund the voluntary program.

FDA says the program will incentivize companies to adopt robust supplier verification programs and will allow the agency to focus its resources on food shipments that pose a higher risk to public health.

The agency estimates it will take an applicant 80 person-hours to compile all the information and complete the application for the VQIP program. FDA expects that it will receive 200 notices of intent to participate in the first year. It also expects to be able to review 200 applications in the first year, depending on the available resources. It anticipates that the program will cost $3.4 million in FY 2018, including the costs of the application review process for 200 applications, the costs of conducting inspections of importers (both foreign and domestic) accepted into the program, the costs of the final determination of eligibility into the program, and annual information technology maintenance costs.

FDA is inviting comments on the draft guidance by August 19, 2015.

FDA’s New Labeling Requirements for Restaurants and Vending Machines

For more than 20 years, FDA has required full nutrition information on the labels of packaged foods. Late last year, the agency published two final rules requiring calorie and other nutrition information for foods sold in restaurants and similar retail food establishments – effective December 1, 2015 – and calorie labeling for food sold in vending machines – effective December 1, 2016. The two rules implement provisions of the Affordable Care Act of 2010.

Menu Labeling

The final rule for menu labeling covers restaurants and similar retail establishments with 20 or more locations, doing business under the same name and offering for sale substantially the same menu item. The covered establishments include:

  • Quick service or sit-down restaurants
  • Take-out restaurants
  • Pizza delivery establishments
  • Food establishments in entertainment venues (e.g., movie theaters, bowling alleys)
  • Cafeterias
  • Coffee shops
  • Superstores
  • Grocery and convenience stores

Food covered by the menu labeling requirements is “restaurant-type” food, which is defined as food usually eaten on the premises, while walking away, or soon after arriving at another location and either served in the establishment or processed and prepared primarily in the establishment. Examples of such foods are:

  • Meals in sit-down restaurants
  • Foods purchased at drive-through windows
  • Take-out food
  • Food ordered from a menu or menu board at a grocery store or convenience store
  • Foods you serve yourself from a salad or hot food bar at a restaurant or grocery store
  • A muffin at a bakery or coffee shop
  • Popcorn purchased at a movie theater or amusement park
  • A scoop of ice cream, milk shake or sundae from an ice-cream store

Alcoholic beverages are covered by the new requirements if they are standard menu items on menus or menu boards in covered establishments. Foods not covered are “grocery-type” foods which are eaten over several occasions or stored for later use (e.g., whole cakes, loaves of bread), foods intended for more than one person or requiring additional preparation before eating (e.g., pounds of deli meats and cheeses, large deli salads), and certain foods bought from bulk bin cases in grocery stores (e.g., nuts, dried fruits, olives from bulk bins).

Covered establishments must post calories for their standard menu items on their menus or menu boards and on signs for self-service food and food on display and provide to the consumer additional written nutrition information for these foods upon request. The covered establishments must also post a statement concerning suggested daily caloric intake and a statement about the availability of the additional nutrition information on menus and menu boards and on the signs for self-service food and foods on display.

A covered establishment must have a reasonable basis for the nutrition information it provides and be able to substantiate the nutrient values if requested by FDA. Restaurants and similar retail food establishments must comply with the menu labeling requirements by December 1, 2015.

Vending Machine Labeling

The final rule for vending machine labeling requires calories to be posted for foods sold in vending machines operated by a person who owns or operates 20 or more vending machines. Vending machines covered by the rule include those that sell:

  • Soft drinks and packaged snacks
  • Hot and cold cup beverages
  • Refrigerated prepared foods
  • Bulk candy and nuts

The calories must be placed on a sign near the article of food or selection button or electronically. If the food item placed in the vending machine permits the perspective customer to view the Nutrition Facts or otherwise provides visible nutrition labeling at the point-of purchase (e.g., front of pack labeling), no further calorie posting is required. Manufacturers of packaged food may want to consider providing front-of- pack labeling that includes calorie declarations for their products that will be sold in vending machines so that vending machine operators are not required to provide additional labeling.

Vending machine operators must provide their contact information on the vending machine so that FDA may contact them for enforcement purposes. Vending machine operators must comply with the vending machine labeling requirements by December 1, 2016.

Detailed information on these final rules is available on FDA’s website: http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm217762.htm

EAS consultants can assist you in understanding and complying with these new menu labeling and vending machine requirements.

  • On July 9, 2015 FDA announced an extension of the Menu Labeling Compliance date to December 1, 2016.  Read FDA’s announcement here.