In May 2016, FDA issued final rules to implement changes to the nutrition labeling and serving size regulations. Mandatory compliance with the new nutrition labeling requirements for food products was initially slated for July 26, 2018 (or July 26, 2019 for manufacturers with less than $10 million in annual food sales). As previously covered on this blog, however, FDA announced earlier this year that the compliance dates for the new nutrition labeling requirements will be extended.
On Thursday, September 14, FDA Commissioner Gottlieb tweeted that the Agency intends to propose an extended compliance date for the new nutrition labeling requirements somewhere in the range of “closer to 18 months.”
We will monitor developments concerning the compliance date for this rule and report them to you here.
The plant-based eating trend continues. On September 13, 2017, the Plant Based Foods Association and the Good Food Institute released new data commissioned from Nielsen reporting that retail sales of plant-based foods intended to replace animal products rose 8.1 percent since last year, topping $3.1 billion in sales.
In particular, Nielsen found that:
plant-based “meats” grew at 6 percent from a year ago;
plant-based meat constituted 2.1 percent of sales in refrigerated and frozen meat products sold at retail, as defined by the Nielsen data set; and
plant-based milk comprised 9.3 percent of milk sales.
Nielsen analyzed data in several categories over a 52-week period ending August 12, 2017. The data represent foods that directly replace animal products, including meat, seafood, eggs, and dairy, as well as meals that contain animal foods replacements. For additional details on this survey click here.
As our readership is well aware, USDA’s Food Safety and Inspection Service (FSIS) regulates the production of meat, poultry, and egg products. To help achieve its enumerated food safety goals, FSIS is continuously seeking to develop and promote best practices at slaughter that may be used to prevent, eliminate, or reduce levels of potential microbiological contamination of the food products subject to its jurisdiction. To this end, in 2014, FSIS published a final rule called the “Modernization of Poultry Slaughter Inspection” (79 FR 49566, Aug. 21, 2014) which amended the poultry regulations to establish an additional inspection system, called the New Poultry Inspection System (NPIS), for young chicken and turkey slaughter establishments. Under the final rule, the maximum line speed for young chicken slaughter establishments that operate under NPIS is 140 birds per minute. See 9 C.F.R. 381.69(a).
On September 1, 2017, the National Chicken Council (NCC) petitioned USDA-FSIS to implement a waiver system to permit young chicken slaughter establishments participating in the NPIS and the Salmonella Initiative Program (SIP) to operate without the line speed limitations imposed under the NPIS.
In particular, NCC requested that USDA structure the waiver program as follows:
An eligible establishment would have to participate in both NPIS and SIP
The establishment would develop a process for monitoring and ensuring it is maintaining process control at its chosen line speed, along with corrective actions to regain process control if lost; and
USDA would waive the line speed limitation in 9 C.F.R. § 381.69(a) and instead allow participating establishments to operate at any line speed at which they can maintain process control.
NCC contends that this waiver program will encourage more establishments to opt into NPIS, will not compromise food safety, and will promote and enhance Agency and industry efficiency.
To support its petition, NCC notes that, since 2007, twenty (20) plants participating in USDA’s HACCP-Based Inspection Models Project (HIMP) have been authorized to operate with line speeds up to 175 birds per minute (bpm) since 2007, and the Agency has recognized that these plants provide the same or better levels of food safety than plants operating with a maximum line speed of 140 bpm.
NCC argues that “granting establishments a waiver of the arbitrary line speed limitation in section 381.69(a) would allow all NPIS establishments the flexibility to choose to operate at appropriate line speeds based on their ability to maintain process control, thereby leveling the playing field within the U.S. chicken industry, eliminating competitive barriers between the U.S. and international chicken producers, removing arbitrary limitations on operational control in establishments, and encouraging more establishments to participate in NPIS.”
Last month, forty (40) groups representing the public health, consumer protection, labor, employer and civil rights sectors asked USDA Secretary Sonny Perdue to oppose any increase in line speeds at U.S. poultry plants.
It remains to be seen how USDA will respond to NCC’s petition.
FDA’s Produce Safety Rule, implemented under the Food Safety Modernization Act (FSMA), establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption. Our detailed summary of the rule is available here. FDA’s Produce Safety Rule, implemented under the Food Safety Modernization Act (FSMA), establishes agricultural water standards. In particular, the Produce Safety Rule sets microbial quality standards for agricultural water, including irrigation water that comes into contact with produce. In March 2017, the U.S. Food and Drug Administration (FDA) announced that it was exploring ways to simplify the agricultural water standards established by FSMA’s Produce Safety Rule in light of feedback from stakeholders that some of the requirements were too complex to understand and implement. Earlier this summer, FDA announced its intention to extend the compliance dates for agricultural water requirements in the Produce Safety Rule (other than for sprouts).
Today FDA issued a proposed rule (82 FR 42963) that, if finalized, would extend the compliance dates for the agricultural water requirements by an additional two to four years (for produce other than sprouts). The proposed extension will give the Agency time to take another look at the water standards to ensure that they are feasible for farmers in all regions of the country, while protecting public health. The new agricultural water compliance date the FDA is proposing for the largest farms is January 26, 2022. Small farms and very small farms would have until January 26, 2023 and January 26, 2024, respectively.
The Agency notes that the proposed extension would also simplify the compliance framework to give all of the water requirements a four-year delay compared to farms’ primary compliance dates. The produce rule currently includes a delay of two years in the compliance dates for certain agricultural water requirements, but for others there is no delay. The FDA indicates that it does not intend to take action to enforce the agricultural water requirements for produce other than sprouts while the rulemaking to extend the compliance dates is underway. Sprouts remain subject to applicable agricultural water requirements in the final rule and their original compliance dates due to their unique vulnerability to contamination.
The publication of the proposed rule comes on the heels of a speech by FDA Commissioner Scott Gottlieb to the annual conference of the National Association of State Departments of Agriculture (NASDA), yesterday, outlining a number of immediate next steps in a comprehensive approach to ensuring successful implementation of the Produce Safety Rule. Gottlieb noted that these steps included measures the Agency will be taking in such areas as compliance dates for agricultural water standards, recognized water-testing methods, and inspections related to non-water requirements of the produce rule.
FDA will be accepting comments on the proposed rule for the next 60 days (i.e., through November 13, 2017).
As previously reported on this blog, the White House issued Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs” on January 30, 2017. A few weeks later, on February 24, 2017, the White House issued Executive Order 13777, which directs each Agency to establish a Regulatory Reform Task Force (RRTF) to evaluate existing regulations and identify those that may merit repeal, replacement, or modification. To assist with implementation of those orders, the U.S. Food and Drug Administration (FDA) asked for input on how the Agency can “can change our regulations to achieve meaningful burden reduction while continuing to achieve our public health mission and fulfill statutory obligations.”
FDA’s call for public comments appeared in seven, separate Federal Register Notices published on September 8, 2017, one directed to each of the FDA Centers, as well as one applicable to general regulatory and information collection requirements that affect multiple FDA Centers. In each Notice, FDA provides a list of questions to help the public in providing comments. The questions include:
Is the regulation still current, or is it outdated or unnecessary in some way? (This could be due to scientific advances, duplicate regulation, etc.)
Have regulated entities had difficulties complying with the regulation?
Does the regulation impose requirements that are also provided for in voluntary or consensus standards or guidance by third party organizations (e.g., International Council for Harmonisation, International Organization for Standardization, Codex Alimentarius)?
Does the regulation contain redundant, outdated, or unnecessary collections of information or retention of records?
Could the goal of the regulation be achieved by less costly means that would provide the same level of public health protection?
What factors should FDA consider in selecting and prioritizing regulations and reporting requirements for reform?
More information, including how to submit comments (which are due by December 7, 2017), is available at the links below:
This is the first request by FDA on how to reduce regulations in response to the Executive Orders mentioned above. However, the Department of Commerce (DOC) asked for input on the impact burdensome Federal regulations this past March. We discussed some of the responses from the food industry to that request on our April 4, 2017 blog. These included the compliance date for the Nutrition Facts Panel and too broad of a definition for “produce” in the FSMA Produce Safety Rule.
As previously reported on this blog, legislation requiring labeling of genetically modified (GM) foods and food ingredients was signed into law on July 29, 2016. This law, entitled the National Bioengineered Food Disclosure Standard, directs the U.S. Department of Agriculture (USDA) to develop regulations and standards to create mandatory disclosure requirements for bio-engineered foods by July 2018. Under the new law, food companies would have three options to disclose GMO ingredients: the use of on-package text, a USDA-created symbol, or an internet link — i.e., a QR code printed on the package that directs customers to GMO information. As part of the development of mandatory disclosure requirements for bioengineered foods, USDA was required to complete a study to identify potential technological challenges that may impact whether consumers would have access to the bioengineering disclosure through electronic or digital disclosure methods. This study was slated to be released in July 2017. As of late August 2017, the study had not been released and so the Center for Food Safety sued USDA to release the study.
On September 6, 2017, USDA released the mandated study (the Study of Electronic or Digital Link Disclosure). The study considered five factors:
The availability of wireless Internet or cellular networks;
The availability of landline telephones in stores;
Challenges facing small and rural retailers;
The efforts that retailers and other entities have taken to address potential technology and infrastructure challenges; and
The costs and benefits of installing in retail stores electronic or digital link scanners, or other evolving technology that provide bioengineering disclosure information.
Highlights of the study’s findings include:
The majority of Americans own a smartphone (77%) and ownership rates are trending upward;
Most Americans live in areas with sufficient broadband access (93.6%) to scan a digital link to access bioengineering food disclosure information;
All national chain stores and most regional chain stores (97%) provide Wi-Fi in store;
Of small retailers, 37 percent already provide Wi-Fi to consumers in store;
Consumers may recognize digital links but lack familiarity with scanning;
Many consumers (85%) experienced technical challenges using certain mobile software applications (“apps”) for scanning digital links; and
Scanning digital links requires access to the internet; therefore, some retailers may need to install Wi-Fi networks for consumers without access to cellular data or local Wi-Fi networks.
Industry groups have had favorable reactions to the study. The Food Marketing Institute, for example, released a statement noting that “in the tradition of food retail’s strong history of customer service, we recognize the need to provide supplemental education to our customers about the information available to them and how to best use the QR Code. And, we are planning to do so in a concerted effort as soon as the final rule is issued and implementation begins.” The Grocery manufacturers Association (GMA) also issued a statement along similar lines noting that it “strongly supports consumers having tools and information to make informed decisions about the products they buy and use” and that “[a] consumer education campaign will be a vital part of the implementation and rollout of the bioengineering disclosure regulation.” However, the study focused on potential challenges that may impact whether consumers can access the bioengineered food disclosure through electronic or digital links. Thus, it will be interesting to see whether QR codes will be an acceptable mechanism for communicating that food is bioengineered.
We will continue to monitor developments on the National Bioengineered Food Disclosure Standard and report them to you here.
A health claim characterizes the relationship between a substance and its ability to reduce the risk of a disease or health-related condition (see21 C.F.R. 101.14). A health claim must contain the elements of a substance and a disease or health-related condition. In addition, health claims are limited to claims about disease risk reduction, and cannot be claims about the diagnosis, cure, mitigation, or treatment of disease. Health claims are required to be reviewed and evaluated by FDA prior to use via a petition process. There are two types of health claims: (1) health claims that meet the standard of significant scientific agreement (SSA) and (2) qualified health claims.
A qualified health claim does not meet the “significant scientific agreement” standard. Therefore, the FDA requires qualified health claims to be accompanied by qualifying language or a disclaimer communicating the level of scientific evidence supporting the claim. Qualified health claims are currently evaluated under FDA’s interim guidance for such claims. FDA issues letters of enforcement discretion when there is credible evidence to support a qualified health claim. For a food to bear a qualified health claim, it is required to be low in fat and contain 10% or more of the Reference Daily Intake or the Daily Reference Value of the nutrients specified in 21 C.F.R. 101.14(e)(6) (i.e. vitamin A, vitamin C, iron, calcium, protein, or fiber per RACC).
On September 7, 2017, the FDA announced that the Agency intends to exercise enforcement discretion for the use of a qualified health claim for infants with severe eczema and/or egg allergy characterizing the relationship between the consumption of foods containing ground peanuts beginning between 4 and 10 months of age and a reduced risk of developing peanut allergy by 5 years of age. The claim, which manufacturers can use immediately, reads:
“For most infants with severe eczema and/or egg allergy who are already eating solid foods, introducing foods containing ground peanuts between 4 and 10 months of age and continuing consumption may reduce the risk of developing peanut allergy by 5 years of age. FDA has determined, however, that the evidence supporting this claim is limited to one study.”
FDA Commissioner Scott Gottlieb released a statement highlighting the Agency’s decision and noting that the FDA will continue to monitor the research related to peanut allergy and, if new scientific information emerges, FDA will evaluate whether the claim should be updated.
FDA’s Produce Safety Rule, implemented under the Food Safety Modernization Act (FSMA), establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption. Our detailed summary of the rule is available here.
On September 5, 2017, FDA announced the availability of a Small Entity Compliance Guide (SECG) to help small businesses comply with the Produce Safety Rule mandated by FSMA. In particular, the SECG is designed to help farmers determine whether they are eligible for a qualified exemption, which would modify the requirements they are subject to under the Produce Safety Rule.
The main compliance dates for small businesses and very small businesses under the Produce Safety Rule are January 28, 2019, and January 27, 2020, respectively, but certain agricultural water requirements have extended compliance dates (see previous blog coverage here). Sprout operations also have different compliance dates, and sprout operations that are small businesses and very small businesses have compliance dates of January 26, 2018, and January 28, 2019, respectively. Businesses that intend to claim a qualified exemption by their primary compliance date were required to begin keeping documentation supporting their eligibility for a qualified exemption on January 26, 2016.
Manufacturers or distributors of new dietary ingredients (NDIs) must submit a pre-market notification called a new dietary ingredient notification (NDIN) to FDA at least 75 days before marketing a dietary supplement that contains an NDI (i.e., one not marketed in the U.S. prior to October 15, 1994). On August 12, 2016, FDA issued a revised Draft Guidance on NDIs and NDINs. The guidance addresses the circumstances under which an NDIN is required, the contents of an NDIN, and the process and timeline associated with NDIN submission and review. Of note, FDA indicated in the draft guidance that it was willing to develop an authoritative list of dietary ingredients that were marketed before October 15, 1994, and consequently exempt from the NDIN requirements in DSHEA.
Today, FDA announced in a Federal Notice (82 FR 42098) that it will hold a meeting on October 3, 2017 to discuss its future development of an authoritative list of old dietary ingredients exempt from notification requirements in the law. The meeting is slated to address two distinct issues that have elicited various opinions among stakeholders:
The standard of evidence required to show an ingredient belongs on the pre-DSHEA list; and
The process by which ingredients should be added to the list, such as the process for nominating and reviewing pre-DSHEA ingredients and how to treat confidential information.
FDA states in the Notice that “by providing clarity as to which ingredients do not require notifications, it would alleviate the burden on industry of preparing and submitting unnecessary notifications.” FDA further states that “by eliminating unnecessary notifications, an authoritative list would enable [the Agency] to more efficiently use [its] limited resources to review notifications for truly ‘new’ ingredients. In addition, an authoritative list would allow [the Agency] to better focus [its] enforcement efforts in alignment with [its] strategic priorities of consumer safety, product integrity and accurate information.”
The registration deadline for the October meeting is September 25, 2017. FDA recommends early registration as seating is limited. To register for the public meeting, click here.
FDA will allow interested parties to comment on the public meeting by submitting electronic or written comments through December 4, 2017. Keller and Heckman LLP has significant expertise in advising the dietary supplement industry. Interested parties with any questions regarding the upcoming meeting or who would like assistance in preparing comments regarding the development of a list of Pre-DSHEA dietary ingredients are encouraged to email us at email@example.com.
As previously reported on this blog, there is an ongoing debate on whether the use of the term “milk” by manufacturers of plant-based products—such as soy milk and almond milk—is a violation of milk’s standard of identity. On one side of the debate, the dairy industry has called on FDA to crack down on the use of dairy-related terms for plant-based products. In January 2017, Senator Tammy Baldwin (D-WI) introduced the DAIRY PRIDE Act, which would have required non-dairy products made from nuts, seeds, plants and algae to no longer be mislabeled with dairy terms such as milk, yogurt or cheese (for more details see our January 31, 2017 blog); but no action was taken on the bill before the end of the 2016/17 Congressional session.
On the other side of the debate, the Good Food Institute (GFI) submitted a petition to FDA in March 2017 requesting that the Agency issue a regulation clarifying that “new foods may be named by reference to other ‘traditional’ foods in a manner that makes clear to consumers their distinct origins or properties.” The group specifically mentioned in the petition that a significant and growing group of consumers has sought to reduce or eliminate dairy product from their diet and that plant-based alternatives to traditional dairy products are becoming more common.
In a letter dated August 29, 2017, FDA told GFI that it had not reached a decision on the petition within the first 180 days of its receipt due to other competing priorities. The Agency added, “We will complete our review of your petition and consider any amendments to our regulations as warranted in the context of other program priorities within the Center.”
Despite requests from both sides for FDA to weigh in on the plant-based milk labeling controversy, the recent letter to GFI does not give any indication of when FDA will address this issue.