• As our readers are well aware, in May 2016, FDA issued final rules to implement changes to the nutrition and dietary supplement labeling and serving size regulations.  Detailed summaries of both rules may be found here.  On August 3, 2016, FDA published a Nutrition Facts label “Industry Resources” web page (available here), which includes some questions and answers, to assist the food industry with compliance with the requirements of the final rules.
  • Today, FDA announced in the Federal Register (here and here) the publication of two draft guidance documents related to the final rules on Nutrition Facts labeling and Serving Sizes to help industry comply with those rules.  See 82 Fed. Reg. 1344 (Jan. 5, 2017) and 82 Fed. Reg. 1347 (Jan. 5, 2017).
  • The first draft guidance provides the Agency’s thinking on the following topics:
    • labeling of added sugars;
    • rounding as it relates to the declaration of quantitative amounts of vitamins and minerals, and
    • label format (thickness of lines and space between lines).
  • Importantly, this draft guidance document also clarifies that products that are labeled on or after July 26, 2018 (and July 26, 2019 for manufacturers with less than 10 million in annual food sales) must bear a nutrition label that meets FDA’s new nutrition labeling requirements).  Products that are labeled before July 26, 2018 (and July 26, 2019 for manufacturers with less than 10 million in annual food sales), however, do not need to be in compliance with the new labeling requirements, and therefore, may bear the old nutrition label.  FDA’s position differs from their original position, which stated that the new nutrition labeling must appear on foods that were initially introduced into interstate commerce on or after July 26, 2018.
  • The second draft guidance provides examples of food products that belong to product categories included in the tables of Reference Amounts Customarily Consumed (RACCs) per Eating Occasion that are established in FDA’s serving size regulations.  The Agency intends for these examples to assist industry in identifying the appropriate food categories for their products and, in turn, determine the serving size on a product’s Nutrition Facts label.
  • FDA is currently accepting comments on the two draft guidance documents; comments submitted to FDA by March 6, 2017 will be considered in the development of the final versions of each document.  Keller and Heckman attorneys are well-versed in the nutrition labeling and serving size requirements and would be glad to assist interested parties in preparing comments for submission to FDA.
  • By way of background, on October 24, 2016, Canada’s Minister of Health launched the Healthy Eating Strategy for Canada. Part of this strategy involves revising Canada’s food labeling requirements over the next 2 years in consultation with Canadians and stakeholders.
  • As part of Health Canada’s Healthy Eating Strategy, on December 14, 2016, final amendments to the Food and Drug Regulations (FDR) – Nutrition Labelling, Other Labelling Provisions and Food Colours were published in Canada Gazette, Part II.
  • Changes to the nutrition facts requirements include:
    • requiring the declaration of the % Daily Value (DV) for sugars (based on the 100 g DV for total sugars established in this amendment);
    • updating the list of nutrients to add potassium and remove vitamin A and vitamin C
    • requiring vitamins and minerals to be declared in both quantitative terms and on the basis of % DVs;
    • requiring a “rule of thumb” footnote to the Nutrition Facts table that states “*5% or less is a little, 15% or more is a lot.”;
    • requiring all sugar-based ingredients to be grouped in the list of ingredients following the term “Sugars”;
    • changes to increase the legibility of the list of ingredients, including:
      • requiring the use of uppercase and lowercase letters;
      • instituting minimum type height requirements for ingredients;
      • requiring good contrast of color (black text or equivalent dark shade of another color on a white or other uniform, neutral color background), with a border around the list or one or more lines above, below or at the sides of the list;
      • prohibiting the practice of horizontal scaling of text (i.e., condensing the width of letters so they take up less space horizontally); and
      • mandating bolding of titles such as “Ingredients” and, when used, “Contains” and “May Contain”;
    • changes to improve the legibility of labeling concerning food allergens, gluten sources and added sulphites when a “Contains” statement is used. Specifically, when a “Contains” statement is used:
      • it must follow the same legibility requirements as those for the list of ingredients; and
      • if the list of ingredients is bound by a border or lines, the “Contains” statement must also be inside the border or lines; and
    • requiring that all food colors be identified by common name as specified in the Food and Drugs Regulations (rather than under the generic name “colours”)
  • See Health Canada’s summary of the food labeling changes here for additional information.
  • While Health Canada develops the nutrition labeling regulations, the Canadian Food Inspection Agency is charged with enforcement.  Industry has a transition period of 5 years (December 14, 2021) to come into compliance with the new labeling requirements.
  • By way of background, on July 14, 2016, FDA issued a final rule to amend and update the Agency’s food facility registration requirements and implement revisions mandated by the Food Safety Modernization Act (FSMA). To support industry compliance with the updated food facility registration requirements, on November 7, 2016, FDA issued a Draft Guidance for Industry entitled “Questions and Answers Regarding Food Facility Registration (Seventh Edition):  Guidance for Industry.” (See previous blog coverage here).  The Draft Guidance contains 15 sections of a multi-section guidance which sets forth the Agency’s current thinking on FDA’s registration requirements.
  • On December 27, 2016, FDA announced the availability of an updated version of the draft guidance, “Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry.” This updated Draft Guidance supersedes the November 2016 version.
  • The December 2016 version of the seventh edition of the Draft Guidance includes 15 sections that were in the November 2016 version, along with two additional sections, namely, “Who is Exempt from Registration?” and “Definitions.” FDA has also revised some of the existing questions and answers and made other editorial changes. A Federal Register notice about the December 2016 version can be found here.
  • All comments submitted by March 27, 2017—for both the November 2016 and December 2016 draft guidance documents—will be considered in the drafting of the final version of the Guidance.
  • Under a standard of identity “milk” is defined as “the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more health cows” (21 C.F.R. Section 131.110).
  • Mike Simpson (R-ID) and Peter Welch (D-VT) and 32 other member of the U.S. House of Representatives sent Food and Drug Commissioner Robert M. Califf, M.D. a letter on December 16, 2016, requesting that FDA enforce the standard of identity for milk. In the letter, the lawmakers stated, “the use of the term ‘milk’ by manufacturers of plant-based products is misleading to consumers, harmful to the dairy industry, and a violation of milk’s standard of identity” and requested that FDA “exercise its legal authority to investigate and take appropriate action against the manufacturers of these misbranded products.” In the letter, lawmakers cited a recent Neilson survey revealing that sales of certain plant-based products labeled as “milk” grew 250% in the past five years while sales of milk fell 7% in 2015.
  • This is an ongoing debate. Dairy organizations have voiced similar concerns in the past (see press release from the National Milk Producers Federation and the International Dairy Foods Association). However, so far, FDA has not sided with the dairy industry.

The Daily Intake is taking a holiday hiatus and will return on January 3, 2017.  We wish you a joyous holiday season and a happy new year. 

FDA has issued an interim final rule to allow more raw fruits and vegetables to bear health claims concerning the relationship between dietary saturated fat and cholesterol and the risk of coronary heart disease.

  • To make a claim regarding the relationship between dietary saturated fat and cholesterol and the risk of coronary heart disease (CHD) a food must typically, among other requirements, contain a certain amount of vitamin A, vitamin C, iron, calcium, protein, or fiber and meet the definitions of a “low saturated fat,” “low fat” and “low cholesterol” food.  Some fruits and vegetables had been ineligible to bear the claim because they do not meet the health claim requirements for containing a minimum amount of certain nutrients and/or they do not meet the definition of a “low fat” food.  For example, grapes, plums, and cucumbers do not contain the threshold levels of vitamin A, vitamin C, iron, calcium, protein, or fiber and avocados do not meet the requirement for “low fat.”  In October 2012, the American Heart Association (AHA) submitted a citizen petition asking the FDA to amend the existing regulation about health claims and the relationship between dietary saturated fat and cholesterol and risk of CHD to expand the use of the claim to certain raw fruits and vegetables that were previously ineligible to make the claim.
  • Today, FDA published an interim final rule (81 FR 91716) to amend 21 C.F.R. 101.75 to expand the use of the heath claim for dietary saturated fat and cholesterol and risk of coronary heart disease (CHD) to certain raw fruits and vegetables that were previously ineligible to make the claim.  More specifically, the Agency is amending the regulation authorizing a health claim on the relationship between dietary saturated fat and cholesterol and risk of coronary heart disease (CHD) to permit raw fruits and vegetables that fail to comply with the “low fat” definition and/or the minimum nutrient content requirement to be eligible to bear the claim.  The Agency is not amending the health claim requirements for frozen or canned vegetables at this time, but invites comment on the issue.
  • The interim final rule takes effect immediately, but industry may submit comments to FDA through March 6, 2017.
  • As previously covered on this blog, BPA was added to the Prop 65 list as a reproductive toxicant in May 2015, with an effective date in May 2016. On April 18, 2016, California’s Office of Environmental Health Hazard Assessment (OEHHA) implemented an emergency rulemaking that allowed the use of point-of-sale (POS) signage to indicate exposures from BPA present in cans, lids, and caps of packaged food and beverages at retails stores until October 17, 2016.  As also reported on this blog, OEHHA issued a proposed rule on July 22, 2016, that would permit the POS signage for BPA until December 30, 2017.
  • On December 2, 2016, OEHHA finalized its regulation regarding POS warnings for foods and beverages packaged in cans or with lids or caps that can cause exposures to BPA. POS warnings will be permitted for such foods and beverages until December 30, 2017. After that date, manufacturers will need to provide warnings pursuant to the more general clear and reasonable warning provisions of the regulations, unless OEHHA further extends the expiration date for use of POS warnings.  To rely on the signage as a safe harbor, however, OEHHA is requiring that manufacturers submit information to OEHHA (and is “encouraging” manufacturers to do so by the end of the year) for inclusion in an online database of products. The POS signage will not apply to products with cans, lids, or caps containing BPA if they are not listed in the database. Additional details on the final rule are summarized in Keller and Heckman’s news alert here.
  • Keller and Heckman LLP attorneys actively advise clients on compliance issues and enforcement actions related to California’s Prop 65. Should you have any questions, please feel free to email us at prop65@khlaw.com.
  • As previously covered on this blog, in November 2015, the FDA announced a final rule regarding the “Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications” which established a voluntary program to certify that foreign food facilities and food produced by such facilities meet applicable FDA food safety requirements.  As our readership is well aware, this final rule is one of several that implement the FDA Food Safety Modernization Act (FSMA).  As also covered on this blog earlier this week, FDA issued final guidance for industry containing recommendations on third-party certification body qualifications for accreditation to conduct food safety audits and to issue food and/or facility certifications under this voluntary third-party certification program.
  • On December 14, 2016, the FDA published a final rule to establish a user fee program to assess fees and require reimbursement for the work the agency performs to establish and administer the third-party certification program.  FDA also announced the fiscal year 2017 application fee for accreditation bodies that wish to be recognized in the third-party certification program ($35,100). The fee is effective January 13, 2017, and will remain in effect through September 30, 2017.
  • Keller and Heckman attorneys regularly advise on FSMA-related compliance, including the third-party certification program, and stand ready to assist interested parties.
  • As our readership is well aware, fruit juice and vegetable juice can be used under certain conditions as color additives in food under 21 C.F.R. 73.250 (fruit juice) and 21 C.F.R. 73.260 (vegetable juice).  The color additive “fruit juice” is defined at § 73.250 as the juice expressed from mature varieties of fresh, edible fruits, or by the water infusion of the dried fruit. Similarly, the color additive “vegetable juice” is defined in § 73.260 as the juice expressed from mature varieties of fresh, edible vegetables, or by the water infusion of the dried vegetable.  Of note, just because a specific plant material can be consumed as food does not necessarily mean that juice from such plant material meets the specifications of the aforementioned regulations.
  • Today, FDA announced the publication of Draft Guidance on “Fruit Juice and Vegetable Juice as Color Additives in Food” to assist manufacturers in determining whether a color additive derived from a particular plant material meets the specifications for fruit juice under § 73.250 or vegetable juice under § 73.260.  This guidance, including FDA’s interpretation of the terms used in § 73.250 and § 73.260, is limited to these specific color additive regulations.  The Agency notes that this guidance does not address the use of fruit- or vegetable-derived color additives that are authorized under different color additive regulations or that are the subject of a color additive petition.
  • The draft guidance issued today follows numerous inquiries submitted to FDA over the years regarding whether certain color additives made from various plant materials would meet the specifications in the fruit juice or vegetable juice color additive regulations. The FDA web page that discusses the draft guidance includes a chart (not in the guidance itself) of the Agency’s responses to questions about whether juice made from a particular source would comply with 21 CFR 73.250 or 73.260 (see here).  The draft guidance published today addresses many of the same points noted in FDA’s responses to industry questions over the years.  Most notably, in its draft guidance, the Agency emphasizes that “only minimal processing methods may be used for the production of the color additives fruit juice and vegetable juice. Such processing does not fundamentally alter a raw fruit or vegetable.” Other than drilling down on this point (with several examples), the draft guidance offers no further new clarity on the processing of the fruit or vegetable into juice, or the extent to which processing is permitted under the regulation.
  • FDA is currently accepting comments on the draft guidance; comments submitted to FDA by February 13, 2017 will be considered in the development of the final version of the guidance. Keller and Heckman attorneys are well-versed in the food additive regulations, particularly the color additive regulations at issue, and would be glad to assist interested parties in preparing comments for submission to FDA.
  • In November 2015, the European Union (EU) adopted a new regulation on novel food, (EU) 2015/2282, which replaces a previous 1997 regulation. (We reported on the European Parliament vote to adopt the new novel food regulation on this blog on November 2, 2015.) Novel food refers to food that Europeans have not consumed to a significant degree prior to May 1997. It includes food from new sources and food obtained through the application of new technologies. Traditional food is a subset of novel foods and refers to food traditionally consumed in countries outside of the EU. Examples include chia seeds, baobab fruit, insects and water chestnuts.
  • The new novel food regulation introduces a centralized assessment and authorization procedure. The two guidance documents on novel food and traditional food, published by the European Food Safety Authority (EFSA), explain what information is required to conduct a risk assessment of these foods. They also clarify how the information should be presented in order for EFSA to assess the safety of the novel or traditional food. For novel food, information should include data on the compositional, nutritional, toxicological and allergenic properties of the food, along with information on the production process and proposed uses and use levels. For traditional food, applicants need to present evidence of safe use of the food in at least one country outside of the EU for a period of at least 25 years.
  • The new novel food regulation comes into effect in January 2018. The guidance document on novel food and the guidance document on traditional food from third countries will assist applicants in preparing the necessary documentation under the new regulation.  Keller and Heckman’s Brussels office is very familiar with the new regulation and the guidance and will be happy to assist or answer any questions.
  • For years, the seafood industry has grappled with the issue of “seafood fraud,” which includes the substitution of cheaper species for more expensive ones.  As previously covered on this blog, on February 5, 2016, the Commerce Department’s National Oceanic and Atmospheric Administration (NOAA) issued a proposed rule to establish a new traceability program for certain seafood species associated with a high risk of illegal, unreported, and unregulated (IUU) fishing and seafood fraud.  The “at risk” list represents approximately 40% of U.S. seafood imports by value.
  • On December 9, 2016, NOAA published a final rule (81 FR 88975) which formally establishes a “Seafood Import Monitoring Program” comprising permitting, reporting and recordkeeping procedures relating to the importation of certain fish and fish products, identified as being at particular risk of IUU fishing or seafood fraud.  The goal of the program is to curb the import of products from IUU fishing and to decrease the incidence of seafood fraud.
  • The mandatory compliance date for most priority species listed in the final rule is January 1, 2018.