FDA issues Q&A on spice safety.

  • In October 2013, FDA released a draft risk profile on the public health risks associated with spices.  The risk profile identified the presence of pathogens, such as Salmonella, and filth in spices as systemic challenges and determined that the problem relates in part to poor or inconsistent use of appropriate controls to prevent contamination.
  • On February 26, FDA issued a Q&A document on spice safety, updating the public on the Agency’s progress and continued activities in this area.  In the Q&A, the Agency references its 2-year nationwide study to collect data on the presence of Salmonella in retail spice products and indicates its hope to complete its analysis and share these results (via the FDA website) “as soon as possible.”  In terms of steps FDA is taking to improve the safety of spices, the Agency notes that it has increased its inspection of spice manufacturing facilities in recent years.  FDA also notes the future application of new requirements under the FDA Food Safety Modernization Act (FSMA) to the spice industry, with spice facilities and spice importers needing to implement hazard analysis and risk-based preventive controls (HARPC) and a Foreign Supplier Verification Program (FSVP) for imported spices.
  • On a positive note, FDA concludes its Q&A document by stating that it is “not recommending that consumers change their consumption or use of spices.”  Nevertheless, the spice industry should stay tuned for future developments and regulatory activity in this area, including the upcoming release of the retail study results.

NYC sodium warning upheld in court.

  • As previously covered on this blog, New York City (NYC) health officials have adopted the nation’s first sodium warning requirement.  The rule requires restaurants that are part of chains with more than 15 locations nationwide to post warning statements about high sodium consumption levels and to display a salt shaker icon on menus and menu boards next to any food item with a high sodium content (>2,300 mg of sodium) or on tags next to any food on display that is a food item with a high sodium content.  The rule took effect on December 1, 2015, and the National Restaurant Association sued the NYC health department, seeking a preliminary injunction to halt its implementation.
  • On February 24, 2016, a New York Supreme Court judge upheld the sodium warning requirement, reasoning that “information is power” and that — unlike in the case of NYC’s controversial failed big soda ban — consumers will be free to use this information to make their own purchasing decisions.
  • The National Restaurant Association maintains that the sodium requirement is arbitrary, capricious, and poised to cause “irreparable harm” to chain restaurants.  An attorney for the association has indicated a plan to appeal, noting that the judge did not address the group’s claim that the sodium rule violated New York’s separation of powers doctrine, premised on the rule’s adoption without legislative guidance from the city or state.  In the meantime, affected chain restaurants have until March 1 to comply with the sodium rule, or else face the possibility of fines.

Maple industry groups ask FDA to take action against alleged imposters.

  • It is unquestionable that the maple syrup industry takes product labeling very seriously.  Illustrative of this vested interest, although the Federal Food, Drug, and Cosmetic Act restricts the ability of states to establish separate standards of identity (SOI) or labeling requirements for foods in general, the preemption clauses contain express carve-outs that permit states to establish their own SOIs and labeling requirements for maple syrup.  Vermont has implemented its own robust maple syrup regulatory framework, and stakeholders in that state remain vocal and active in their efforts to police and protect the marketplace for genuine maple syrup.
  • Earlier this month, several maple syrup industry groups sent a letter to FDA requesting that the Agency take enforcement action against food products labeled as “maple,” but that do not contain maple syrup.  The letter was sent by maple syrup producer groups in Connecticut, Indiana, Maine, Massachusetts, Michigan, Minnesota, New York, Vermont and Wisconsin, as well as the International Maple Syrup Institute and the North American Maple Syrup Council.   The petitioners collectively ask FDA to require companies to remove the “maple” branding from nine specified products (including oatmeal and ice cream, among others) or to add maple syrup to those products.
  • According to media reports, FDA has said it is reviewing the letter and will respond directly to the petitioners.  Although it is not yet clear how the Agency plans to respond, the publicity surrounding this incident highlights the potential risks associated with “maple” claims and the willingness of the maple industry to take concrete action in this area.

FDA issues guidance to help food companies comply with final rule for omega-3 fatty acid claims.

  • In April 2014, FDA published a final rule prohibiting certain nutrient content claims for foods and dietary supplements containing the omega-3 fatty acids:  docosahexaenoic acid (DHA); eicosapentaenoic acid (EPA); and alpha-linolenic acid (ALA).  In short, the rule eliminated a number of proposed nutrient content claims for DHA, EPA, and ALA, but FDA agreed that it would not take action against certain nutrient content claims for ALA.  The rule became effective on January 1, 2016 (which was the uniform compliance date for all labeling regulations that FDA issued between January 1, 2013 and December 31, 2014).
  • FDA has now issued a Small Entity Compliance Guide to help food companies comply with the final rule.  The guidance restates the requirements of the rule using plain language and a Q&A format.  It clearly indicates which types of nutrient content claims for DHA and EPA are prohibited by the rule, and which claims for ALA remain permissible, namely “High,” “Good Source,” and “More” claims.
  • The food industry has had some time to adjust to these changes in the landscape for omega-3 fatty acid claims, but the new user-friendly guidance document still may serve as a helpful resource to companies seeking guidance in this area.

FDA reportedly to begin testing for glyphosate residues in foods.

  • Glyphosate is the active ingredient in Roundup and is reported to be the most-used agricultural chemical in the world.  The International Agency for Research on Cancer (IARC) has labeled this herbicide as “probably carcinogenic to humans,” although the European Food Safety Authority (EFSA) disputes that conclusion.  In the United States, FDA has not routinely tested foods for the presence of glyphosate, in spite of a U.S. Government Accountability Office (GAO) recommendation that the Agency improve its testing methods and be more transparent with the public regarding the limitations of its analytical testing.
  • According to numerous media reports, an FDA spokesperson recently announced that the Agency will begin testing foods for glyphosate residues.  The Agency reportedly has developed more “streamlined” methods to test for this chemical and is preparing plans to measure glyphosate levels in soybeans, corn, milk, and eggs, among other potential food products, in Fiscal Year 2016.
  • Glyphosate remains the subject of global controversy, with some environmental groups calling for a ban on use of the substance in agriculture.  Monsanto, the maker of Roundup, maintains that the herbicide is safe and has expressed confidence that FDA’s residue testing — if done in a scientifically rigorous manner — will reaffirm glyphosate’s safety.

Vermont issues GM labeling FAQs.

  • As food manufacturers are well aware, Vermont’s GM labeling requirements remain on track to take effect on July 1, 2016.  Although the requirements are being challenged in the Second Circuit and some still hope for a federal legislative fix, neither avenue is guaranteed to provide relief to the industry before the effective date.
  • Recently, the Vermont Attorney General’s Office issued a series of Frequently Asked Questions (FAQs) to assist stakeholders with understanding the labeling requirements and the timeline for implementation.  The FAQs are intended to complement the formal guidance document issued last September.  Among other issues, the FAQs clarify the existence of a “safe harbor” for foods distributed in Vermont prior to July 1, 2016 and offered for retail sale until January 1, 2017.  After the latter date, manufacturers of products that do not comply with the GM labeling requirements may be liable for penalties, regardless of the date the product was produced or distributed.
  • Although many food manufacturers may have adopted a “wait-and-see” approach to their compliance strategies in 2015, there is no concrete legal basis to justify further delay at this stage.  In fact, these FAQs are further evidence that Vermont has no intention of providing any further delay or relief in enforcing the law.  On the federal front, Senator Pat Roberts (R-Kansas) has just introduced legislation to establish a national voluntary labeling standard for GM foods.  The bill is similar to the Safe and Accurate Food Labeling Act of 2015 (which the House of Representatives passed in July 2015) and would preempt state requirements in this area, including Vermont’s.  As before, we will track the progress of this bill and continue to report on GM labeling developments as the clock ticks down to July 1.

Parmesan cheese makes headlines for alleged economic adulteration.

  • The concept of “food fraud” or “economic adulteration” refers to the whole or partial replacement of genuine foods and food ingredients with cheaper substances without informing the customer or consumer of the substitution.  Food fraud can also refer to the fraudulent mislabeling of a product grade or quality, or adulterating the product with undisclosed and typically less expensive additives to boost the bottom line.  A prime example of food fraud is mislabeled extra virgin olive oil, identified by the EU Parliament as the top food fraud problem in the world.  Extra virgin olive oil is often rancid, or mixed with refined olive oil or cheaper seed oils.  Food fraud can destroy margins for honest producers, and can cause consumer confusion which can erode margins for higher quality product categories  in the long run.
  • Recently, parmesan cheese has been making headlines due to allegations that products marketed as “100% parmesan” may contain unexpectedly high quantities of cellulose fiber.  In 2013, FDA warned Castle Cheese, Inc. for marketing “parmesan cheese” products that did not contain any actual parmesan cheese.  Those allegations ultimately crippled the company and resulted in criminal charges being filed against its president.  This week, a new report by Bloomberg News suggests that parmesan cheese purity problems may now be an industry-wide issue.  Although FDA technically permits cheese makers to use cellulose in cheese to prevent clumping, the Bloomberg report indicates that some producers are using as much as four times the amount necessary to serve this function.
  • One problem with high-profile food fraud examples is their ability to call into question the integrity of the entire market for that product category, creating headaches for finished food marketers and problems throughout the supply chain.  As part of FDA’s hazard analysis and risk-based preventive control (HARPC) requirements, companies soon will be required to take economic adulteration into consideration as part of their mandatory food safety compliance strategies.  For more information on the complex interplay between new food safety requirements, potential liability, and insurance considerations, we invite you to register for an upcoming webinar on March 29, 2016 at 1 p.m. Eastern Time.  More information about this program (including a registration link) is available here.

Federal law preempts California slack fill challenges for USDA-regulated products.

  • Under the California Fair Packaging and Labeling Act, companies can be challenged for including “nonfunctional slack fill” in product packaging.  Slack fill is the empty space between products and their packaging, and the goal of California’s requirements is to prevent consumer deception when products are packaged in containers that are larger than necessary for any technical reason related to packaging and shipping.  California is very active in enforcing its slack fill requirements.  In 2012, several counties threatened enforcement action against a company’s meat and poultry products for alleged violations of the state’s nonfunctional slack fill provisions.
  • The Ninth Circuit now has ruled that California’s nonfunctional slack fill provision is preempted as it relates to meat and poultry products.  In its ruling, the court found that the legislative history of the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA) showed Congressional intent to create a uniform national labeling standard for meat and poultry products.  The three-judge panel concluded that the “same concern about uniformity applies to the packaging standards [in the instant case] and counsels against allowing the states to develop variant standards.”  Although the FMIA and PPIA contain no express requires related to nonfunctional slack fill, USDA regulations prohibit products from being sold in packages or containers that are filled in a “misleading” manner.  The Ninth Circuit found express federal preemption of the state requirements in this case.
  • The preemption ruling applies only to meat and poultry products, which are subject to stringent USDA standards and label pre-approval.  Although the case may be a welcome relief to processors of USDA-regulated products in California (and states that similarly attempt to enforce slack fill requirements in this area), the marketers of FDA-regulated food products must remain vigilant.

House passes bill to increase flexibility in FDA’s menu labeling requirements.

  • As previously covered on this blog, FDA has issued a final rule to implement the menu labeling provisions added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by the Affordable Care Act.  Under the new requirements, restaurants or similar retail food establishments (in chains of 20 or more locations doing business under the same name and selling substantially similar menu items) must provide calorie and other nutrition information for standard menu items.  Although the menu labeling requirements originally were scheduled to take effect on December 1, 2015, FDA extended the compliance date to December 1, 2016.  Then, as part of the omnibus spending legislation passed in December 2015, Congress further delayed FDA’s ability to enforce compliance with menu labeling requirements until one year after final guidance is published.  Despite the issuance of draft guidance and delays in implementation, many industry stakeholders have remained concerned about FDA’s requirements and how they apply to different food service models and food products.
  • On February 12, the House of Representatives passed H.R. 2017, the “Common Sense Nutrition Disclosure Act,” which is intended to give restaurants and retailers more flexibility to comply with FDA’s menu labeling requirements.  Specifically, the bill would:
    • permit the designation of a “primary” menu or menu board in a restaurant or similar retail establishment where all required nutrition information may be displayed;
    • clarify that ads are not menus or menu boards and thus do not need to bear nutrition labeling;
    • permit “reasonable” variations between nutrient content disclosures and actual nutrient content, such as variations in serving size, inadvertent human error in formulation or preparation of menu items, variations in ingredients, or “other reasonable variations”;
    • permit restaurants where most orders are placed remotely (e.g., pizza chains) to provide nutrition information via “a remote-access menu” (such as a menu available on the Internet), as opposed to needing to supply information on-site;
    • permit restaurants to provide nutrition information in a calories-per-serving format based on the number of servings reasonably believed to be in a “standard menu item” (e.g., on a “per slice” basis), as opposed to listing the number of calories in the whole item (e.g., a whole pizza or a whole cake);
    • permit the use of alternative disclosure methods (e.g., ranges, averages, individual labeling, or the labeling of one “preset standard build”) for standard menu items that come in different flavors, varieties, or combinations, but which are listed as a single menu item;
    • eliminate criminal penalties for menu violations;
    • give restaurants and similar retail establishments found to be in violation of the requirements 90 days to correct their error(s), penalty-free, after receiving notice of the violation(s) from FDA; and
    • bar private civil actions for violations of the FDA menu labeling requirements or similar requirements under state law.
  • The White House and consumer advocacy groups (such as the Center for Science in the Public Interest) oppose the bill, asserting that the additional flexibility would undermine the public health goals of the menu labeling requirements.  However, industry stakeholders view the bill as a welcome source of relief from what many view as FDA’s overly rigid, “one-size-fits-all” approach to menu labeling.  At this point, it is up to the Senate — and then, potentially up to the President’s veto power — to decide whether this bill ultimately will grant the industry the flexibility it seeks.

FDA extends comment period on proposed rule for gluten-free labeling of fermented or hydrolyzed foods.

  • As previously covered on this blog, FDA issued a proposed rule to address the application of “gluten-free” labeling requirements to fermented and hydrolyzed foods and foods that contain fermented and hydrolyzed ingredients.  The underlying issue is that uncertainty prevails in interpreting the results of current test methods for detecting gluten in such foods.
  • On February 12, FDA announced its intent to extend the comment period for this proposed rule.  Although the comment period technically closes on February 16, FDA will be reopening it to extend the timeframe for an additional 60 days (to be counted from the date that a notice reopening the comment period appears in the Federal Register).
  • The proposed rule would affect the labeling of foods and ingredients such as yogurt, hydrolyzed soy protein, distilled vinegar, and FDA-regulated beers (i.e., beers that are not made from malted barley and hops).  The rule also could affect beers regulated by the Alcohol and Tobacco Tax and Trade Bureau (TTB), as TTB has indicated that it may revise its own gluten claim policy once FDA has issued a final rule or other guidance.  Interested stakeholders are invited to submit comments via Regulations.gov (Docket Number FDA-2014-N-1021).