• As previously covered on this blog, the general compliance date for the foreign supplier verification program (FSVP), under the Food Safety Modernization Act (FSMA), is May 30, 2017. The U.S. Food and Drug Administration recently issued updated fact sheets, and new guidance on how to identify the importer under the FSVP Rule.
  • The May 30th deadline generally applies to importers whose foreign supplier falls into one of the following categories:
  • Although not reflected in the newly-issued guidance, FDA announced in August 2016 that with respect to food contact substances (FCSs), importers have an additional two years to meet the FSVP requirements; as a result, the earliest FSVP compliance date for FCSs is May 28, 2019.
  • In the guidance, FDA has clarified that it will be permissible to use the code “UNK” (to represent “unknown”) in the unique facility identifier (UFI) field if the FSVP importer is temporarily unable to obtain a Dun & Bradstreet (D&B) Data Universal Numbering System (DUNS) number.
  • We will continue to monitor and report on FDA’s activities to implement the FSVP rule and other FSMA related activities. Please feel free to contact us at fooddrug@khlaw.com with any questions.
  • As previously covered on this blog, in December 2016, FDA announced the publication of Draft Guidance on “Fruit Juice and Vegetable Juice as Color Additives in Food” to assist manufacturers in determining whether a color additive derived from a particular plant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.  The issuance of this draft guidance followed numerous inquiries submitted to FDA over the years regarding whether certain color additives made from various plant materials would meet the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  The Agency was initially slated to accept comments on the Draft Guidance through February 13, 2017, and subsequently reopened the comment period through May 1, 2017.
  • On May 12, 2017, FDA announced the withdrawal of the 2016 Draft Guidance based on comments received that raised substantive technical concerns. The concerns include that the guidance promoted practices that may be inconsistent with current industry practices intended to enhance food safety.  In particular, Archer Daniels Midland Company (ADM) contended that the Draft Guidance did not reflect current industry practices as it appeared to set into motion a premarket consultation process.  And the Grocery Manufacturers Association (GMA) expressed concerns that the Draft Guidance’s focus on “minimal processing” would preclude the use of a number of existing industry practices for making safe colors from fruit and vegetable juices.
  • Although FDA is withdrawing this draft guidance, the Agency notes that the regulations authorizing certain plant-derived color additives remain in place and that the Agency will continue its practice of responding on a case-by-case basis to industry questions on these topics.  At the same time, the Agency intends to continue evaluating information submitted to its docket and consulting with stakeholders to consider next steps.
  • As previously covered on this blog, U.S. beef has been denied access to China for nearly 14 years due to concerns stemming from a case of bovine spongiform encephalopathy that occurred in Washington state in December 2003.  In September 2016, China announced that it had lifted its ban on imports of U.S. beef, but attempts to negotiate the technical terms of access faltered in the ensuing months, and so – to date – American beef producers have not yet been able to resume exports to China.
  • Late yesterday, the White House announced that China would resume beef imports no later than July 16, 2017 as part of a broader trade agreement with China that also aims to improve access of American electronic payment providers and natural-gas exporters to the Chinese market.  In return, in the realm of agriculture, the U.S. has pledged that it will remove obstacles to importing cooked Chinese poultry meat.
  • The restoration of U.S. beef access to China represents a financial win for American beef producers as the Chinese market for American beef exports stands at an estimated $2.6 billion. Following the White House announcement, The National Cattlemen’s Beef Association issued a press release noting that “It’s impossible to overstate how beneficial this will be for America’s cattle producers.”
  • As background, whole genome sequencing (WGS) essentially provides insight into the genetic fingerprint of a pathogen by sequencing the chemical building blocks that make up its DNA.  Since 2012, FDA has regularly turned to WGS to better understand foodborne pathogens, including identifying the nature and source of microbes that contaminate food and cause outbreaks of foodborne illness. For example, FDA reports that WGS was recently used to help match samples of soft cheese to the genetic fingerprint of Listeria monocytogenes involved in a deadly foodborne illness outbreak in early March 2017.
  • Two FDA officials leading the Agency’s WGS efforts in the food safety realm recently explained in a podcast that FDA laboratories are currently testing new genome sequencers that are said to be faster, cheaper and more mobile – with the potential to fit into a briefcase that could go out to the consumer safety officer and actually do field testing.  FDA is also working with global partners to advance this technology.
  • It remains to be seen the extent to which WGS may potentially revolutionize the way in which food regulatory bodies, including the FDA, achieve their enumerated food safety and public health goals.
  • As previously covered on this blog, on January 19, 2017, USDA published a controversial final rule on organic livestock and poultry which establishes minimum indoor and outdoor space requirements for chickens as a function of type of production and stage of life, as well as adds new provisions for livestock handling and transport for slaughter. 82 FR 7042.  The effective date for this rule was initially March 20, 2017.  On February 9, 2017, USDA delayed the effective date to May 19, 2017.
  • Today, USDA published a Notice in the Federal Register (82 FR 21677) delaying the effective date of the final rule for an additional six months to November 14, 2017.  The Agency also concurrently published a Second Proposed Rule (82 FR 21742) requesting comments on the final rule through June 9, 2017.  USDA is specifically requesting feedback on which of the following four actions USDA should take with regard to the disposition of the final rule:
    • Let the rule become effective. This means that the rule would become effective on November 14, 2017.
    • Suspend the rule indefinitely. During the suspension, USDA could consider whether to implement, modify or withdraw the final rule.
    • Delay the effective date of the rule further, beyond the effective date of November 14, 2017.
    • Withdraw the rule so that USDA would not pursue implementation of the rule.
  • Today’s announcement comes on the heels of the Organic Trade Association (OTA) sending a letter late last month to USDA urging the Agency to avoid further delays to the implementation of the final rule.  OTA’s letter noted that the rule has received strong support throughout the organic chain, from organic producers to the organic consumer.  Critics of the rule include some “farm-state” lawmakers and farm groups who believe the rule could raise food prices and force some farmers out of business.
  • Given the controversial nature of the final rule, the ultimate fate of this rule continues to remain unclear.

As we predicted on this blog in November 2016, more jurisdictions have now followed the lead of cities like Berkeley, Philadelphia, San Francisco, Oakland and Boulder by introducing legislation to tax sweetened beverages. However, these efforts are not always successful.

  • On May 2, 2017, Santa Fe, New Mexico voters rejected a proposed tax of two cents per fluid ounce on sugar-sweetened beverages to be paid by distributors. Funds raised from the tax would have supported early childhood education. It is noteworthy that in Santa Fe political spending on the soda tax initiative was estimated at $163 per vote, higher than any other city that has voted on implementing a sugar-sweetened beverage tax.
  • In Massachusetts, the FY 2018 budget was passed without an amendment that would have established a tiered tax on sugar sweetened beverages. The bill’s sponsor, Rep. Kay Khan (D), withdrew the amendment but will continue to advocate for a tax on sugar sweetened beverages during the current legislation session. (See Bloomberg BNA.) She introduced H.3329, “An Act to Promote Healthy Alternatives to Sugary Drinks,” in January 2017. Two other jurisdictions that recently proposed sweetened beverages taxes are Seattle and Multnomah County (where Portland, Oregon is located).
  • In April, Seattle Mayor Ed Murray announced a proposed ordinance to impose a tax on distributors of sugar sweetened drinks to fund programs “aimed at eliminating the opportunity gap between white students and African American/Black and other students of color.” The proposed tax of 1.75 cents per ounce of sweetened beverage would apply to sodas, energy and sports drinks, fruit drinks, sweetened teas, and ready-to-drink coffee drinks. Infant formula, 100% fruit juice, medicine and milk-based products would be exempt.
  • Voters in Multnomah County, Oregon may have an opportunity to decide in November if the county should impose 1.5 cents per ounce tax on sugary drinks—including soda, energy drinks and sweetened teas—to help pay for early childhood education and other educational programs. Diet sodas would be among the beverages exempted from the tax. Health advocates will need to gather 17,381 signatures to get the measure placed on the ballot, according to the Portland Patch.
  • As more states and local jurisdictions look at taxing sweetened beverages to compensate for budget short falls, we will continue to report on this trend.
  • As our readership is well aware, the use of antibiotics in food-producing animals has become a hot button issue in the food industry, with at least one leading consumer advocacy group formally calling for food labeling on meat and poultry products that discloses antibiotic use or nonuse.  While such efforts are not likely to move forward in today’s regulatory climate, many consumers have expressed a penchant for “ethically-raised”, clean label foods such as “Cage Free” and “Pasture Raised.”
  • In the realm of antibiotic claims for food products, on May 3, 2017, NSF International launched a “Raised Without Antibiotics” certification program to certify animal products have been raised without exposure to antibiotics. NSF International developed the “Raised Without Antibiotics”  certification protocol in partnership with the food industry and veterinary stakeholders. Of note, the use of ionophore chemical coccidiostats – which are not considered contributors to antimicrobial resistance – may be permitted to prevent infections, depending on labeling regulations in the region of product sale.  The certification may be sought for a variety of animal products, including meat, poultry, seafood, dairy, eggs, leather and certain supplement ingredients.
  • This new NSF certification program provides industry with a key marketing tool amid consumer concerns associated with the use of medically important antibiotics to promote growth or feed efficiency in food-producing animals.
  • As previously covered on this blog, on September 9, 2015, NYC health officials voted unanimously to adopt the nation’s first sodium warning requirement.  The rule, which went into effect on December 1, 2015, applies to all restaurants that are part of chains with more than 15 locations nationwide.  Restaurants are required to display a salt shaker icon on menus and menu boards next to any food item — whether a standard menu item or a combination meal — 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.  Restaurants also must post the following statement conspicuously at the point of purchase:  “Warning: [salt shaker icon] indicates that the sodium (salt) content of this item is higher than the total daily recommended limit (2300 mg).  High sodium intake can increase blood pressure and risk of heart disease and stroke.” The City began issuing notices of violations for non-compliance of this rule on June 6, 2016.
  • The National Restaurant Association (NRA) sued to halt the rule soon after the rule became effective, calling it “arbitrary and capricious” and initially kept it from being enforced for months.  In February 2017, however, a New York appeals court ruled in favor of New York City, agreeing with a lower court that the New York City Board of Health “did not exceed their authority” by adopting the warning rule.  The NRA immediately announced plans to explore its legal options, but failed to file an appeal by last Wednesday’s deadline for doing so.
  • It remains to be seen the extent to which other jurisdictions will follow New York City’s lead in imposing sodium warning requirements and, in particular, whether New York City’s recent win on the sodium warning score combined with their related regulatory measures (i.e., trans fat ban and calorie count disclosure requirements in restaurants) will further embolden other jurisdictions to move forward with similar plans.
  • Enacted in 2010, the Healthy, Hunger-Free Kids Act (HHFKA) set rigid nutrition standards for schools and paved the way for the subsequent implementation of school meal rules that many in the industry argue have limited the flexibility of school foodservice providers, led to increased food waste in school cafeterias, and resulted in declining participation in the National School Lunch and Breakfast Programs. USDA’s Final Rule: Nutrition Standards in the National School Lunch and School Breakfast Programs, for example, imposes stringent sodium limits and whole grain and dairy requirements.  Recently, there have been increasing calls to scale back on these requirements.  For example, just last month (and as previously covered on this blog), U.S. Senator Pat Roberts (R-Kan.), Chairman of the Senate Committee on Agriculture, Nutrition, and Forestry, sent a letter to the USDA urging regulatory relief from rigid school meal standards.
  • On May 1, 2017, U.S. Secretary of Agriculture Sonny Perdue announced that the USDA will provide greater flexibility in nutrition requirements for school meal programs in order to make food choices both healthful and appealing to students.  Perdue signed a proclamation which begins the process of restoring local control of guidelines on whole grains, sodium, and milk. The specific flexibilities provided for under the proclamation include:
    • USDA will allow states to grant exemptions to schools experiencing hardship in serving 100 percent of grain products as whole-grain rich for school year 2017-2018.
    • For School Years 2017-2018 through 2020, schools will not be required to meet Sodium Target 2. Instead, schools that meet Sodium Target 1 will be considered compliant.
    • Perdue will direct USDA to begin the regulatory process for schools to serve 1 percent flavored milk through the school meals programs.
  • The granting of this regulatory relief is a win for industry, but is sure to be followed by at least some push back from public interest groups.  Margo Wootan, Director of Nutrition Policy for the Center for Science in the Public Interest, for example, described the Perdue’s May 1st announcement as “discouraging”, noting that “ninety percent of American kids eat too much sodium every day.” But given the data that the more stringent nutrition requirements led to increased food waste in school cafeterias and declining participation in the National School Lunch and Breakfast Program, it is clear that USDA will be moving towards increased flexibility when it comes to school meal program nutrition requirements, with the complete rolling back of the Obama-era school nutrition requirements a possibility.
  • As previously reported on this blog, FDA received a Citizen Petition from KIND in December 2015 requesting that the Agency revisit the definition of “healthy” — which has not changed since 1994 — to take into account present-day scientific understanding about the health benefits of many nutrient-dense foods, and in September 2016, FDA issued a request for comments on the use of the term “healthy” on food labels. The Agency received over 1,000 comments by the time the comment period closed on April 26, 2017.
  • In its request for comments, FDA pointed out that the KIND Citizen Petition specifically requested that the Agency update its nutrient content claim regulations to be consistent with current federal dietary guidance, and that the regulation defining the nutrient content claim “healthy” be amended to emphasize whole foods and dietary patterns rather than specific nutrients. Many of the comments from industry focused on specific food products.
    • The New York City Departments of Health and Mental Hygiene, and of Consumer Affairs support allowing all raw, single-ingredient nuts, legumes, seeds, fruits and vegetables to be called “healthy.” However, several industry groups would like that list expanded. Sun-Maid Growers of California suggested that dried fruit with no added sugars should be equally eligible as raw, canned or frozen fruit to use the claim “healthy” on their labels, and the Juice Products Association requested that 100% fruit and vegetable juices and 100% juice blends should also be eligible. The Cranberry Institute stated that FDA should not negate a food’s ability to be labeled as “healthy” if it does not meet criteria for a single nutrient, such as total fat or added sugars; rather, it should be based on a food’s total nutrient content and its role in a healthy eating pattern.
    • Citing evolving scientific evidence supporting the health benefits of unsaturated fats like the type found in avocados, the Hass Avocado Board suggested that limiting the use of “healthy” to foods that are low in total fat is inconsistent with current federal dietary guidance. Also citing advances in science, the United Egg Producers stated that the regulatory threshold for cholesterol content is outdated and should be deleted in its entirety. The group added, “FDA should exempt foods from meeting the low-saturated-fat requirement for the ‘healthy’ claim if they are specifically identified as nutrient-dense.”
  • FDA has not provided a timeline as to when revisions to the definition of “healthy” might occur.  While FDA considers industry’s comments on how best to redefine the term “healthy”, food manufacturers may continue to use the term “healthy” on foods that meet the current regulatory definition (21 CFR 101.65(d)). FDA has also issued a guidance document, stating that FDA does not intend to enforce the regulatory requirements for products that use the term “healthy” provided that certain criteria described in the guidance document are met.