FDA requests comments on “healthy” definition and issues guidance regarding the use of the term “healthy” in the labeling of human food products.

  • FDA regulations prescribe qualifying criteria for foods to bear the claim that they are “healthy” (including related terms) (21 CFR 101.65(d)).  Among other factors, a “healthy” food generally must contain 3 grams or less of total fat per serving and 1 gram or less of saturated fat per serving.  (Fish and meat are required to contain 5 grams or less of total fat per serving and 2 grams or less of saturated fat per serving).  As previously covered on this blog, FDA received a Citizen Petition last December 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.
  • Today, FDA announced that it is now officially requesting information and public comment on the use of the term “healthy” as a nutrient content claim on food labeling.  While FDA considers how to redefine the term “healthy”, food manufacturers may continue to use the term “healthy” on foods that meet the current regulatory definition. FDA has also issued a guidance document, effective today, 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.
  • In its request for comment, FDA poses a series of nuanced questions, including – but not limited to:
    • whether the term “healthy” is most appropriately categorized as a claim based only on nutrient content;
    • whether nutrients for which intake is encouraged should be intrinsic to the foods, or whether the nutrients could be provided in part – or in total – via fortification; and
    • whether “healthy” is the best term to characterize foods that should be encouraged to build healthy dietary practices.
  • The Agency also requests feedback on consumer perceptions of the term “healthy” as it relates to food and the public health benefits of defining the term “healthy” or similar terms in food labeling.
  • FDA will be accepting comments on the “healthy” definition for 120 days following its imminent publication in the Federal Register.

The American Beverage Association (ABA) is spearheading a lawsuit challenging Philadelphia’s soda tax which is slated to take effect on January 1, 2017. 

  • As previously covered on this blog, on June 16, 2016, the Philadelphia city council voted 13-4 to approve a 1.5 cent per ounce tax on sugar-sweetened beverages.  The tax, which is slated to take effect on January 1, 2017, covers a variety of beverages, including soda and diet soda, non-100% fruit drinks; sports drinks; flavored water; energy drinks; pre-sweetened coffee or tea; and non-alcoholic beverages intended to be mixed into alcoholic drinks.  The tax will be levied on distributors, and the city expects to begin collecting tax revenues on January 1, 2017.
  • On September 14, 2016, the American Beverage Association (ABA) together with retailers, distributors and consumers filed a complaint in a Court of Common Pleas challenging Philadelphia’s soda tax.  The plaintiffs claim that the tax represents a violation of the Sterling Act, a Pennsylvania state law declaring that cities and local governments “shall not have authority to levy, assess and collect… any tax on a privilege, transaction, subject or occupation, or on personal property, which is now or may hereafter become subject to a State tax.”  This lawsuit follows on the ABA’s promise to take legal action against the tax in a June 16, 2016 press release responding to the passage of the Philadelphia soda tax earlier that day.
  • The reaction to Philadelphia’s tax continues to be predictably mixed, with industry largely opposed to the measure, and consumer advocacy groups lauding the potential benefits from the standpoint of reducing sugar consumption.  It remains to be seen what, if any, impact the outcome of the Philadelphia lawsuit will have on the appetite of other U.S. jurisdictions to pursue such legislation.

A district court judge has denied USDA’s motion to dismiss a lawsuit alleging that the Agency illegally changed its process for reviewing synthetic substances used in organic production.

  • By way of background, the U.S. Department of Agriculture (USDA) administers the National Organic Program (NOP), which includes standards for “organic” food in the United States.  The use of synthetic substances generally is prohibited in organic foods, with the exception of specific materials that have been evaluated and added to a National List of allowed and prohibited substances.  On September 16, 2013, USDA published a notice in the Federal Register, indicating a change in its listing process for synthetic substances.  Prior to September 2013, synthetic materials were removed by default from the National List after a five-year “sunset” period, absent a specific vote to keep them on the list.  Post-September 2013, the new process permits synthetic materials to remain by default on the national list, absent a specific vote to remove them.  As previously covered on this blog, in response to this change, the Center for Food Safety (CFS) and other groups sued USDA in a California federal court, asserting that USDA’s change in policy — which did not allow for public comment — violates the Administrative Procedure Act and the Organic Food Production Act.
  • On September 8, 2016, U.S. District Judge Haywood Gilliam for the Northern District of California issued a ruling denying USDA’s motion to dismiss the lawsuit.  In denying the Agency’s motion, Judge Haywood determined that the Plaintiffs adequately established injury-in-fact, finding that Plaintiffs alleged a concrete and particularized harm resulting from the revised sunset procedure.  More specifically, Judge Haywood noted that the Plaintiffs cited specific substances that they allege remain used in organic production because of the revised procedures, and contend that as a result of the continued presence of these substances on the National List, Plaintiffs must use increased effort to advocate for changes to the National List due to the revised sunset notice procedure.
  • Should the court ultimately overturn USDA’s revised sunset notice, certain substances relied upon by many in the production of organic foods will automatically expire in the absence of NOSB review and approval.  Given increasing consumer demand for organic foods, and the corresponding increasing market share for such products, the disposition of this case continues to be of great interest to industry and consumers alike.

FSIS has issued a new Directive addressing steps it would take in the event of an HPAI or agro-terrorism incident.

  • As our readership is well aware, USDA’s Food Safety and Inspection Service (FSIS) is the federal agency charged with protecting the nation’s poultry and meat supply. Highly pathogenic avian influenza (HPAI) and agro-terrorism concerns prompted FSIS to issue a Directive targeting both issues back in 2009.
  • On September 21, 2016, FSIS issued a new directive, updating procedures established in 2009, to instruct its inspectors at poultry slaughter facilities on steps to take in the event of a highly pathogenic avian influenza (HPAI) outbreak or agro-terrorism incident.  Highlights of the enhanced inspection procedures include:
    • USDA’s Animal and Plant Health Inspection Service (APHIS) has responsibility activities in the event of an outbreak, including defining the control areas and issuing permits for flock movement.
    • Public health veterinarians are to examine every truckload of birds from control areas during ante-mortem inspection.
    • Inspectors must retain all carcasses exhibiting signs of HPAI for veterinary disposition.
    • When public health veterinarians suspect that birds or carcasses exhibit clinical signs or lesions consistent with HPAI, they are to stop the establishment from further slaughtering the flock, retain all affected birds, carcasses and parts, and contact the district office.
  • Poultry industry stakeholders should review this Directive to understand the steps that FSIS and APHIS will take should an HPAI or agro-terrorism event arise.

Lawmakers are seeking to upend the controversial USDA Catfish Program. (subscription to Food Chemical News required)

  • As previously covered on this blog, earlier this year, FDA transferred jurisdiction over catfish inspection to USDA.  By way of background, FDA regulates the majority of the U.S. food supply, while USDA exercises jurisdiction over meat, poultry, and egg products.  Although FDA historically has regulated fish and fishery products, the 2008 Farm Bill required FDA to divest its authority over the inspection of Siluriformes fish (including catfish) to USDA’s Food Safety Inspection Service (FSIS).
  • On September 13, 2016, two hundred lawmakers sent a letter to House of Representative leaders calling for “immediate consideration” of a bipartisan resolution that would scrap USDA’s catfish program, arguing that the best use of taxpayer dollars is to have one regulator for seafood – FDA.
  • The catfish inspection program continues to prove controversial, with some industry stakeholders insisting that USDA jurisdiction over catfish provides a marketplace advantage, while many others contend that it is a waste of regulatory and taxpayer resources.  It remains to be seen how the House leadership will respond, but in the meantime, it remains clear that this inspection program will continue to generate controversy.

NRDC and six other advocacy groups have petitioned FDA, requesting the withdrawal of approvals for several medically important antibiotics in livestock and poultry.

  • 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.
  • On September 13, 2016, the Natural Resources Defense Council (NRDC) and six other groups petitioned the FDA to withdraw approval of the use of medically important antibiotics in livestock and poultry for disease-prevention or growth-promotion purposes.  The petition specifically calls for approvals to be withdrawn for seven classes of antibiotics recognized as important to human medicine: macrolides, lincosamides, penicillins, streptogramins, tetracyclines, aminoglycosides, and sulfonamides.  NRDC’s petition contends that FDA’s guidance, which promotes the judicious use of therapeutic antimicrobial drugs in food animals, has not gone far enough in reducing antibiotic use.
  • In light of FDA’s demonstrated preference for working with industry to gradually phase out the use of medically important antimicrobials in food animals for production purposes (e.g., to enhance growth or improve feed efficiency), it appears that the petitioners have a hard road ahead.  Regardless of how FDA responds to this petition, it is clear that antibiotic resistance remains a hot-button public health concern.

On the heels of recently released draft guidance concerning substantiation for infant formula structure/function claims, FDA has issued guidance regarding the labeling of infant formula.

  • Infant formula is clearly receiving attention at FDA in 2016.  Just earlier this month, as covered on this blog, FDA released draft guidance concerning appropriate substantiation for structure/function claims made in infant formula labeling.  Earlier this year, FDA issued guidance on production of exempt infant formula.
  • On September 16, 2016, FDA issued guidance entitled, Labeling of Infant Formula.  This guidance, which represents the current Agency thinking on this topic, clarifies requirements pertaining to the following infant formula labeling elements:
    • Statements of identity;
    • “Exempt” infant formula;
    • Nutrient content claims;
    • Health claims and qualified health claims
    • Additional infant formula labeling requirements, including directions for preparation and use, pictograms, use-by dates, water statement and symbol, warning statements, and physician’s recommendation; and
    • General labeling requirements, including intervening material, foreign language and religious symbols, statements intended for specific religious needs, and allergen statements.
  • In issuing this guidance document, FDA noted its concerns regarding the number of infant formula products that bear the same or similar statements of identity but are different in composition or intended use.  The Agency also noted that it has observed an increased use of nutrient content claims that render products misbranded under the Federal Food, Drug, and Cosmetic Act.
  • The issuance of this latest guidance could result in additional scrutiny of infant formula labels.  As such, infant formula manufacturers should be certain to ensure that their products’ are appropriately labeled, and well-positioned to defend them against any potential challenges.

This week, FDA began issuing warning letters to retailers for improper sale of newly deemed tobacco products.

  • On August 8, 2016, FDA’s Deeming Rule went into effect.  Although many parts of the regulations will not be enforced for months or years, several important provisions are active and impacting industry.  Specifically, FDA is now inspecting retailers of newly deemed covered tobacco products, such as cigars or e-liquids, for compliance with youth access restrictions.  On September 15, 2016, FDA announced it issued warning letters to 55 retailers for the sale of newly-regulated tobacco products to minors.
  • Over the last several years, CTP has developed a nationwide compliance check inspection program.  FDA inspectors are commissioned through contracts with states and third-party contractors to conduct undercover buy and advertising and labeling inspections at tobacco retailers.  FDA reviews the evidence and retailers observed violating the youth access restriction provisions of the Tobacco Control Act and accompanying regulations are first issued a warning letter.
  • If inspectors observe retailers committing multiple violations within one to two years, tobacco product retailers may receive civil money penalties, which can now reach up to $11,002.  If a retailer is cited for five or more repeated violations within 36 months, they may receive a no-tobacco-sale order, which start at 30 days and escalate to a permanent prohibition on the sale of tobacco products.
  • To comply with FDA’s tobacco sale restrictions, retailers should always check photo identification of anyone under age 27 who requests to purchase a tobacco product.  Retailers should never sell tobacco products to customers under age 18.  FDA’s instructions regarding these and other provisions that apply to retailers are available here.

FDA will continue reviewing how medically important antimicrobials are given to animals in feed or water.

  • FDA announced this week that it is “entering the next phase” of efforts to avoid increased antimicrobial resistance.  This phase will involve limiting use of “medically important antimicrobials” – those that are also important for human disease treatment – by first seeking additional information from the public regarding the feeding of those products to animals “without a defined duration of use.”
  • FDA will accept public comments regarding this issue for 90 days after September 14, 2016.  FDA wants to learn about currently approved products “that lack defined durations of use on their labels.”  Specifically, FDA seeks comments regarding the underlying diseases requiring these drugs, targeted use regimens, livestock husbandry practices, and labeling strategies to update drug labels with a defined duration of use.
  • FDA reiterated its expectation that on January 1, 2017, medically important antimicrobials will only be used for “therapeutic animal health purposes.”  Interested parties should submit comments by December 13, 2016.

FDA awards funding to states to help implement FSMA

  • Late last week, FDA announced it would award $21.8 million to 42 states, with the amount per state based on the estimated number of farms growing produce covered by FSMA in that state.  The goals of the partnership are to provide states with financial assistance to develop the data and infrastructure necessary to implement produce safety rules at the local, state, and national level, and encourage states to create inspection, compliance, and enforcement programs.
  • The funding was offered through two channels.  First, funding was offered for state or territory food agencies to develop infrastructure for education and farm inventories.  The program will focus on creating an inventory of farms, developing regulatory infrastructure, and preparing for future enforcement and outreach programs. 
  • Additionally, states were invited to apply for funding that would become available in future years to help states implement compliance programs for the FDA Produce Safety Rule.  States that pursued this second tier of funding were required to “confirm their jurisdiction’s intent to adopt the FDA Produce Safety Rule in its entirety” or make state employees available to FDA commissions to assist in inspection and enforcement activities.
  • This funding will increase state (and, by extension, FDA) resources available to monitor and enforce safety standards for the production of fruits and vegetables.  Under this program, FDA will likely receive more granular data regarding state and local growers, which it could use to guide future enforcement or educational activities.