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.
USDA has issued a request for information (RFI) to inform the design of studies intended to assist the Agency with developing mandatory disclosure requirements for bioengineered foods.
- As previously discussed on this blog, on July 29, President Obama signed S. 764 into law, establishing a federal framework for the labeling of genetically modified (GM) foods and food ingredients. This law directs the U.S. Department of Agriculture (USDA) to develop regulations and standards to create mandatory disclosure requirements for bioengineered foods by July 2018.
- USDA’s Agricultural Marketing Service (AMS) has issued an RFI to help inform the design of two studies needed to establish a National Bioengineered Food Disclosure Standard. One study will identify potential nationwide technological challenges that may impact whether consumers would be able to rely on electronic or digital links on food packages. The second will evaluate the likelihood consumers will use electronic or digital disclosures.
- This RFI, which primarily seeks input from vendors interested in conducting the Food Disclosure Standard studies, represents one of the first substantial Agency actions in connection with the implementation of the new federal GMO labeling law. Comments are due to USDA by September 15, 2016.
California is considering adding aspartame to its Proposition 65 Listing. Proposition 65 is the California state law requiring labeling warnings on products containing substances “known by the state of California to cause cancer.” (subscription to Food Chemical News required)
- Aspartame is an artificial, low-calorie, non-saccharide sweetener used as a sugar substitute and flavor enhancer in certain foods and beverages. One of the most extensively studied substances in the human food supply – aspartame was originally approved by FDA in 1981 for uses, under specific conditions, as a tabletop sweetener, and in chewing gum, cold breakfast cereals, and dry bases for certain foods (i.e., beverages; instant coffee and tea; gelatins, puddings, and fillings; and dairy products and toppings). In 1983, FDA approved aspartame for use in carbonated beverages and carbonated beverage syrup bases, and in 1996 FDA approved it for use as a “general purpose sweetener”. In addition, numerous studies conducted by the FDA, the Joint Expert Committee on Food Additives (JECFA) of the World Health Organization and Food and Agriculture Organization, and the Scientific Committee on Food of the European Union (SCF) – among others – support the safety of aspartame.
- Despite an abundance of studies from regulatory agencies in more than 100 countries supporting aspartame’s safety, aspartame will be the subject of an upcoming November 15, 2016 meeting in which the Carcinogen Identification Committee (CIC) – California’s qualified experts on carcinogenicity for purposes of Prop 65 – will be providing the state’s Office of Environmental Health Hazard Assessment (OEHHA) with advice on the prioritization of aspartame for possible preparation of hazard identification materials. The potential listing of aspartame comes against the backdrop of FDA’s 2014 denial of two Citizen Petitions, available here and here, that sought a ban of aspartame; in denying the petitions, FDA noted that numerous studies support the safety of aspartame for use in human food among the general population. See FDA’s denial letters here and here.
- Given the substantial scientific literature favoring the safety of aspartame, and FDA’s fairly recent denial of petitions seeking to ban aspartame, it remains to be seen whether California will ultimately add aspartame to its Prop 65 listing.