While you were (hopefully) lounging at the beach or hiking mountains, the FDA was hard at work in Washington D.C. churning out final rules and guidance documents that impact food companies in various, and sometimes substantial, ways.

Some of those updates were expected (e.g., Nutrition Facts updates) and some were a surprise (e.g., a finalized GRAS rule, nineteen years after its first proposal). Recognizing that not everyone considers these rules and guidance documents fun summer reading (as they are for us #foodlawnerds), we’ve provided a brief overview of some of those changes to help food companies prepare for the next year. Over the coming weeks, look for more in-depth blogs about what these changes mean for food companies.

Before we jump in to the FDA’s accomplishments, let’s not forget that in July Congress managed to pass a bipartisan piece of legislation establishing mandatory labeling of genetically-engineered food. The law, which preempts Vermont’s genetically-engineered food labeling law, gives food companies three options for disclosing the presence of genetically-engineered food. The United States Department of Agriculture’s Agricultural Marketing Service is spearheading the rulemaking process and is required to have rules in place within the next two years. Check out our blog on it here. Without further ado, the FDA’s summer food-related accomplishments include:

Consumer Packaged Goods Food Labeling & Other

  1. Nutrition Facts Label – Final Rule: The Nutrition and Supplement Facts panels got a makeover this summer (we blogged about it here). The changes indicate an important shift, which will influence marketing and consumption trends, from specific nutrient levels to the source of those nutrients. Here are some of the highlights:
  • Manufacturers will be required to disclose “added sugars” – in both grams and as percent daily value – as well as “Total Sugars.” This was the most controversial of the FDA’s changes; companies objected saying that there is no difference between naturally present sugars and added sugars.
  • “Calories from fat” is no longer required to be labeled, with the FDA noting that “research shows that the type of fat is more important than the amount.”
  • Serving sizes (a.k.a. reference amounts customarily consumed) for certain food products (like ice cream and soda) have been updated to reflect the amount of that food consumers actually eat in one sitting. Packages that are between one and two servings will be required to be labeled as one serving.
  • “Calories” will be more prominent – must be in a larger font size and bolded.
  • “Dietary fiber” is now defined and the calculation of calories for fiber content has changed.
  • Vitamins A and C are no longer required to be disclosed, but vitamin D and potassium are (along with iron and calcium).
Companies with $10 million or more in annual food sales must comply with the new regulations by July 26, 2018; others will have an extra year to comply.
  1. Use of “Evaporated Cane Juice” – Final Guidance: Over the past few years, numerous food companies have been sued for their use of “evaporated cane juice” on their food labels. This summer, the FDA finally provided its views in the form of guidance: it is “FDA’s view that sweeteners derived from cane sugar should not be declared on food labels as ‘evaporated cane juice.’” Instead, the FDA says, the ingredient should be labeled as “sugar.”
  2. Generally Recognized as Safe (GRAS) – Final Rule: In August, the FDA released a final rule concerning substances that are “generally recognized as safe” (GRAS) and therefore not subject to FDA pre-market approval, like food additives. This final rule formalized the voluntary GRAS notification procedure that has been in place for nearly two decades and clarified the criteria for GRAS status.  The rule has been criticized by some as allowing companies to make GRAS determinations without informing the FDA.
  3. Voluntary Sodium Reduction Initiative – Draft Guidance: The FDA released draft guidance that establishes two voluntary sodium reduction targets for the food industry: a short-term (2-year) target to reduce sodium intake to approximately 3,000 mg per day, and a long-term (10-year) target to decrease sodium intake to approximately 2,300 mg per day. The FDA is seeking comment on this voluntary initiative. Comments for the short-term target are due by Oct. 17, 2016 and comments on the long-term target are due by Dec. 2, 2016.
Restaurant/Vending Machine Labeling
  1. Menu Labeling – Final Guidance: In late April, the FDA published its final guidance for the industry on compliance with federal menu labeling laws, which require restaurants and retail food establishments with twenty or more locations to provide calorie and other nutrition information for standard menu items and food on display. The guidance appears to be the final step to enforcement of the previously released regulations – the compliance date is one year from publication in the Federal Register, and the FDA says it will start enforcement in May 2017.
  2. Calorie Labeling on Vending Machines – Small Entity Compliance Guide and Draft Guidance: Under the Affordable Care Act, persons who own or operate twenty or more vending machines are required to post calorie information about the food sold in the vending machine. The FDA released a Small Entity Compliance Guide (SECG) and draft guidance to assist businesses in complying with the final vending machine labeling rule, and seeks comments on both guidance documents. Comments should be submitted by Sept. 30, 2016 to be considered in during drafting of the final guidance.
Food Safety
  1. Preventive Controls for Human Food Rule – Draft Guidance for Qualified Facilities: Under the Food Safety Modernization Act, food facilities that have less than $500,000 in annual food sales and sell primarily to local and regional markets (called qualified facilities) are subject to certain modified requirements for the processing and manufacturing of food. The FDA released draft guidance to assist those facilities in complying with the requirements of the Preventive Controls for Human Food Rule. The draft guidance is open for public comment until Nov. 14, 2016.
  2. Food Defense – Final Rule: Under the Food Safety Modernization Act, most food facilities are required to prepare and implement a food defense plan that addresses issues of intentional adulteration of food. The final rule outlines and further describes the requirements for a company’s food defense plan, which include identifying
    vulnerabilities and actionable process steps, mitigation strategies, and procedures for food defense monitoring, corrective actions and verification.
  3. Amendments to Food Facility Registration – Final Rule: Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, food facilities are required to register with the FDA. The final rule published by the FDA this summer, as part of the Food Safety Modernization Act, requires food facilities provide additional information in their registration with the FDA. The rule took effect July 14, 2016, and food facilities whose registration renewal period is October-December 2016 must comply with those new requirements.
  4. Extension of Certain Compliance Dates under the Food Safety Modernization Act: Sept. 19, 2016 is a marker day for food facilities as the enforcement date for many of the new regulatory requirements under the Food Safety Modernization Act. Over the summer, the FDA announced it would extend the compliance date for certain requirements, which include: (1) provisions regarding customer assurances when preventive controls are applied by other entities further down the distribution chain; (2) requirements for facilities solely engaged in packing and/or holding of raw agricultural commodities that are produce and for certain facilities that qualify as “secondary activities” farms; (3) provisions under the Foreign Supplier Verification Program for the importing of food contact surfaces; and (4) requirements for certain facilities producing certain Grade “A” milk and milk products to comply with current good manufacturing practices.