The FDA has issued Draft Guidance for Industry entitled “Questions and Answers Regarding Food Facility Registration (Seventh Edition)”

  • As previously covered on this blog, over the past several months, FDA has issued guidance documents to support the implementation of various FSMA requirements,see e.g., here, here, and here.
  • On November 7, 2016, the FDA issued a Draft Guidance for industry entitled “Questions and Answers Regarding Food Facility Registration (Seventh Edition):  Guidance for Industry.”  The Draft Guidance contains 15 sections of a multi-section guidance which sets forth the Agency’s current thinking on FDA’s registration requirements.  Of note, FDA has issued a revised (Seventh Edition) version of this Draft Guidance as Level 1 Draft Guidance pursuant to 21 CFR 10.115, and includes additional questions and answers relating to the Amendments to Registration of Food Facilities final rule (Registration Final Rule) (81 FR 45912; July 14, 2016) that revised FDA’s registration regulations and other questions and answers regarding food facility registration.  The new questions and answers are identified with the date that they were added to the Guidance with the newest revisions marked as “[Added November 2016].”  The issuance of this Draft Guidance comes in the midst of the 2016 Food Facility Registration biennial renewal period which began on October 1, 2016 and will end on December 31, 2016.
  • Comments on the Draft Guidance may be submitted to FDA at any time, but comments received by February 6, 2017 will be considered in the drafting of the final version of this Guidance.

Packaging Color Impacts Consumers’ Perception of Both “Healthiness” and “Taste” of Foods

  • As reported on this blog in September, FDA is considering how to redefine the term “healthy” and has requested public comments on the use of the term as a nutrient content claim on food labeling. In addition to labeling, food manufacturers also often use light colored packages to draw attention to a food products’ healthiness. However, this can be a double-edged sword, according to new research published in the Journal of Retailing.
  • The article, “Light and Pale Colors in Food Packaging: When Does This Package Cue Signal Superior Healthiness or Inferior Testiness?” reported that manipulating different aspects of real food products resulted in conflicting color/taste associations. For example, study participants that were not particularly health-conscious rated the same product in lighter colored packages as healthier, but also less tasty, even when they were allowed to taste the product. “Since human abilities are too limited to distinguish more or less healthy products by taste…healthiness evaluations were guided by package color even after the consumers had tried the product,” explained the authors in a release on the research. Although, when tasting wasn’t involved, the more health-conscious participants paid less attention to the packaging color.
  • Consumer perception of the healthiness of a food product is impacted by a number of factors, all of which food manufacturers need to take into consideration when formulating and marketing that product.

Massachusetts will vote on a ballot initiative that would ban certain means of confining farm animals in the state.

  • Consumers are increasingly demanding ethically-minded foods such as “Cage Free” and “Pasture Raised”.  Coupled with a heightened focus from animal welfare advocacy groups on animal raising conditions, it should come as no surprise that, earlier this summer, the Massachusetts Supreme Court approved a ballot initiative proposing that Massachusetts prohibit breeding pigs, calves raised for veal, and egg-laying hens from being held in confined spaces.  The law would also apply to business owners who knowingly sell pork, veal, or eggs from animals held in a prohibited manner, even if the source is outside of Massachusetts.
  • The“Massachusetts Minimum Size Requirements for Farm Animal Containment,” also known as Question 3, is on the November 8, 2016, ballot in Massachusetts as an indirect initiated state statute.  Voting “yes” on this ballot initiative would support a prohibition on the sale of eggs, veal, or pork of a farm animal confined in spaces that prevent the animal from lying down, standing up, extending its limbs, or turning around.  The measure proposes a maximum fine of $1,000 for each violation.  If Massachusetts voters approve this ballot initiative, Massachusetts would become the first state to regulate containment conditions for food animals.
  • It remains to be seen whether and to what extent the Massachusetts vote on this ballot initiative will influence similar legislative or regulatory efforts.

 

Natural Resources Defense Council (NRDC) recently filed a petition with USDA calling on the Agency to offer chicken produced without the routine use of antibiotics important to human medicine (“certified responsible antibiotic use chicken”) in the National School Lunch Program.

  • As previously covered on this blog, for years, FDA, USDA, and various stakeholders have grappled with how to address concerns about the use of medically important antibiotics to promote growth or feed efficiency in food-producing animals.  For example, in 2013, FDA asked animal pharmaceutical companies to voluntarily revise the FDA-approved conditions of use on antibiotic labels to remove production indications.  In March 2015, Dianne Feinstein (D-CA) and Susan Collins (R-ME) reintroduced a bill that would require FDA to withdraw its approval of medically important antibiotics that are at a high risk of abuse in food-producing animals.  And in October 2015, California passed legislation to curb the use of antibiotics in livestock.  Most recently, on September 21, 2016, the United Nations held a ministerial meeting on antimicrobial resistance (see previous blog coverage here).
  • On October 20, 2016, the NRDC filed a petition with USDA calling on the Agency to offer chicken produced without the routine use of antibiotics important to human medicine (“certified responsible antibiotic use chicken”) to schools in the National School Lunch Program through the USDA Foods program.  In particular, the petition asks the USDA to create commodity specifications for certified responsible antibiotic use chicken products, and add those products to the USDA Foods List, so that schools and State Distributing Agencies may order them.
  • NRDC’s petition is not unprecedented given the increased spotlight on antibiotic resistance fears, and consumers increasing penchant for “antibiotic free” foods.  Regardless of how USDA responds to this petition, it is clear that antibiotic resistance remains a trending public health concern.

Following on the recent issuance of a final rule updating reference amounts customarily consumed (RACCs) for various foods, FDA has issued a Request for Information (RFI) on the appropriate RACCs for flavored nut butter spreads.

  • As previously covered on this blog, earlier this year, FDA issued a final rule related to various aspects of the serving size regulations, including updates to RACCs for previously established product categories and the creation of RACCs for new products and product categories.  This final rule became effective on July 26, 2016.  The compliance date is July 26, 2018 for manufacturers with $10 million or more in annual food sales, and July 26, 2019 for manufacturers with <$10 million in annual food sales.
  • On November 2, 2016, FDA issued a request for information (RFI) to invite comments, data and other relevant information on the appropriate RACC and product category for flavored nut butter spreads (e.g., cocoa, cookie, and coffee flavored), as well as products that can be used to fill cupcakes and other desserts.  The Agency notes that it has issued this RFI in response to:
  1. A comment received on the proposed version of the final rule discussed above.  This comment requests that FDA amend the serving size regulations to establish a RACC and product category for cupcake fillings.  In the preamble to the final rule, the Agency responded to the comment by noting that it intended to establish a RACC for cupcake fillings, as well as for other types of cake or pastry fillings, in a future rulemaking.  The RFI issued on November 2, 2016 represents the first step in the Agency’s evaluation of the appropriate RACC and product category for products used as a filling for cupcakes and other desserts; and
  2. A citizen petition asking that FDA either: (a) issue guidance recognizing that “nut cocoa-based spreads” fall within the “Honey, jams, jellies, fruit butter, molasses” category for the purposes of RACC determination, or (b) amend the current regulation relating to RACCs to establish a new RACC category for “nut cocoa-based spreads” with a RACC of 1 tablespoon.
  • FDA will be accepting comments on the RFI through January 3, 2017.

FDA has released small entity compliance guidances under the Food Safety Modernization Act (FSMA) to support the implementation of the Preventive Controls for Human Food and Preventive Controls for Animal Food rules for small and very small businesses.

  • As previously covered on this blog, over the past several months, FDA has issued guidance documents to support the implementation of various FSMA requirements, see e.g., here, here, and here.
  • On October 31, 2016, FDA released small entity compliance guidances (available here and here) under FSMA to assist small and very small businesses with the implementation of the Preventive Controls for Human Food and Preventive Controls for Animal Food. This follows on guidance issued in August 2016 for both the human and animal food rules. Key takeaways from the small entity compliance include:
    • Small businesses, i.e., those with fewer than 500 full-time employees, must comply with the human and animal food rules by September 18, 2017.
    • Very small businesses, i.e., those typically averaging less than $1 million per year in human food sales or $2.5 million per year in animal food sales, are required to maintain records supporting Qualified Facility status as of January 1, 2016.
    • Qualified facilities must come into compliance with the human and animal food rules by September 17, 2018.
  • Comments may be submitted to FDA on the small entity compliance guidances at any time.  Additional FDA guidance documents to support the implementation of FSMA are forthcoming.

• Attacks on excess sugar in the diet are coming from all directions. On September 1, 2016, we reported that, The American Heart Association Recommends Dramatically Reducing “Added Sugar” Intake; and, last month on this blog, we discussed the number of jurisdiction in the U.S. and abroad that have or are planning to tax sugary products, and the effectiveness of those taxes. Also, in less than two years, on July 26, 2018, manufacturers with $10 million or more in annual food sales will be required to list “added sugars,” in grams and as percent Daily Value on the Nutrition Facts panel of packaged foods and beverages sold in the U.S.

• As attacks on sugar consumption heat up, consumers are taking notice. Recent research by CivicScience found that consumers are more concerned about the amount of sugar in their diet than previously. In response to the question, “Which of these do you feel is most harmful to your nutritional health?” 26% choose “added and total amount of sugar” in 2016, up from 24% in 2015. The only category to have a higher response is “preservatives/chemicals,” although that category decreased from 36% to 33% between 2015 and 2016. CivicScience noted that 15% of adults believe that the total amount of sugar is most harmful, while 12% believe added sugar is the most harmful. Since responses to both categories increased by the same amount, the research company combined the options.

• As a result of the increased concern about sugar in the diet, CivicScience suggested that companies may want to switch the focus from “preservative-free” and “all natural” to terms such as “made from natural sugars” or “no sugar added.” At a minimum, food and beverage manufacturers need to carefully consider the level of sugar when (re)formulating products and developing labels since this is a trend that will continue into the foreseeable future.

FDA has released draft guidance for industry regarding suppliers’ disclosure of uncontrolled hazards in foods as required by four rules implementing the Food Safety Modernization Act (FSMA).

  • As previously covered on this blog, over the past several months, FDA has issued guidance documents to support the implementation of various FSMA requirements, see e.g., here and here.
  • On October 28, 2016, FDA issued a draft guidance document that addresses disclosures required to be provided by a supplier when certain hazards in food have not been controlled.  A disclosure requirement is included in four of the FSMA rules—the preventive controls rule for human food, the preventive controls rule for animal food, the produce safety rule, and the foreign supplier verification program (FSVP) rule.  The draft guidance reflects FDA’s current thinking on how to describe the hazard under each of the four rules, and which documents the Agency considers to be “documents of the trade” for the purpose of the statements accompanying the food.  Key takeaways from the guidance include:
    • Under the human and animal food preventive controls rules and the FSVP rule, FDA would consider a general disclosure for biological hazards (e.g., “microbial pathogens” as opposed to “Salmonella”) to be adequate, but not for chemical or physical hazards.  FDA expects chemical or physical hazards to be disclosed in more specific terms (e.g., “mycotoxins”, “aflatoxin”, “stones”).
    • With respect to the appropriate method of disclosure, FDA expects the disclosures to be made via documents such as “labels, labeling, bill of lading, shipment-specific certificates of analysis, and other documents or papers associated with the shipment that a food safety manager for the customer is likely to read”.
    • The disclosure requirements under the produce safety rule align with those applicable to human and animal food preventive controls rule and the FSVP rule except that the draft guidance does not specifically address chemical and physical hazards as these are not required to be controlled under the produce safety rule.
  • Comments submitted to FDA by May 1, 2017 will be considered in preparing the final version of the guidance.

USDA’s National Organic Program recently held a webinar updating the public on developments surrounding improvements to its Organic INTEGRITY Database.

  • As our readership is well aware, organic production in the U.S. is regulated by the U.S. Department of Agriculture’s National Organic Program (NOP) under the Organic Foods Production Act of 1990 (OFPA) (Public Law 101-624, Nov. 28, 1990).  To support the continued development of organic production in the U.S., the NOP recently rolled out the Organic INTEGRITY Database, funded by the 2014 Farm Bill.   The database, formally launched in September 2015, contains up-to-date information on certified organic farm or business around the country, and may be used to readily search for an operation with specific characteristics. For example, the site contains a classification system for categorizing products that carry USDA organic certification.
  • On October 26, 2016, the NOP held a webinar updating the public about recent improvements to the Organic INTEGRITY Database.  An archive of NOP’s webinar is available here.  Major takeaways from the webinar included:
    • Certifiers can now log in to the database, and regularly update the list of organic operations they certify;
    • Certifiers can now track the history of an operation to support certification and compliance activities;
    • Industry and the public can now perform increasingly sophisticated advanced searches by operation status effective date, exact product name, and other criteria;
    • Certifiers can now avoid recertifying suspended operations that have not been reinstated by NOP; and
    • Certifiers can now produce and operations can verify federated organic certificates through INTEGRITY
  • The NOP continues to engage industry and the public to make improvements to the Organic INETGRITY Database and, in particular, is working with organic certifiers to encourage regular data submittals and accurate data.

The Grocery Manufacturers of America (GMA) has requested that the short-term sodium reduction goals be extended to at least four years, and that FDA account for differing functional roles of sodium in its proposed sodium targets for certain food categories.

  • As previously covered on this blog, on June 1, 2016, FDA issued a draft guidance document that provides voluntary sodium reduction targets for various food categories, specifically aimed at food manufacturers, restaurants, and food service operators. The draft guidance sets forth a 2-year goal of reducing intake to 3,000 mg per day and a 10-year goal of reducing intake to 2,300 mg per day.  As also covered on this blog, FDA subsequently announced an extension of the comments period for its draft guidance such that the comment period for 2-year sodium reduction targets was extended to October 17, 2016 (instead of August 31, 2016), and the comment period for the 10-year targets is now December 2, 2016 (instead of October 31, 2016).
  • In response to FDA’s proposed 2-year sodium reduction targets, on October 17, 2016, GMA submitted comments to FDA recommending that the timeline to meet the short-term reduction goals be extended to at least four years. GMA also proposed accounting for differing functional roles of sodium in its proposed sodium targets for certain food categories. GMA’s comments are available here.
  • The food industry has been voluntarily reducing sodium in products for years and, as evidenced by GMA’s recent comments, is eager to continue working with FDA to achieve the Agency’s sodium reduction goals.