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FDA agenda gives priority to nutrition, modernizing standards of identity

FDA to reopen comments on criteria for updating and setting standards of identity

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True to its promise to industry, FDA appears to be putting modernization of standards of identity high on its priority list for at least the next six months.

According to FDA’s regulatory agenda, which was released Oct. 17, the agency is looking to revoke at least two outdated standards of identity for specific foods and seek input again on a proposed rule that updates the framework for setting food standards of identity.

The agenda also suggests that FDA will follow up on its efforts earlier this year to remove partially hydrogenated oils (PHOs) from food and is planning to issue a rule proposing to remove the remaining uses for PHOs.

The agency also plans to update the definition of “healthy” and is planning issue a proposed rule in March that will outline how the claim can be used on food labels. While it remains unclear what the agency’s approach would eventually look like, the agenda suggests that FDA is looking to establish a definition based on food groups recommended by the Dietary Guidelines for Americans (DGA) and address which nutrients should be limited.

According to FDA Commissioner Scott Gottlieb, these and other efforts outlined in the fall 2018 regulatory agenda reflect the agency’s commitment to advancing the public health goals of FDA’s new Nutrition Innovation Strategy.

But advocates at the Center for Science in the Public Interest (CSPI) are already pointing at gaps in the agency’s latest, six-month regulatory schedule and are suggesting that FDA, among other things, should be doing more to both advance FSMA implementation and achieve the agency’s large-scale goals of improving public health by implementing an updated approach to nutrition.

Gottlieb says agenda would advance key nutrition priorities

Gottlieb says that FDA’s semi-annual Fall 2018 Unified Agenda includes “key actions that will improve labeling and nutrition.”

The agenda, he said in an Oct. 17 blog, supports important steps for implementing FDA’s Nutrition Innovation Strategy – a multi-year plan for modernizing FDA’s approach to nutrition, which includes goals, such as establishing a definition for the claim “healthy,” modernizing standards of identity and simplifying ingredient lists.

Among other goals, that plan seeks to stimulate industry innovation and incentivize producers to develop healthier foods, while also empowering consumers to make better nutritional choices and reducing the incidence of nutrition-related diseases, Gottlieb said in his blog. 

“The Fall 2018 Unified Agenda reflects our continued commitment to these priorities,” explained Gottlieb.

One example of that is the agency’s plan to issue a proposed rule that would remove all mention of PHOs (which are also known as trans fat) in FDA regulations and revoke all prior sanctioned uses.

The proposed rule will allow FDA to follow up on earlier action on PHOs and help reduce deaths from coronary heart disease, Gottlieb wrote.

Noting that experts no longer believe PHOs to be generally recognized as safe (GRAS) in food, FDA in June ushered in the deadline for U.S. manufacturers to stop producing foods that contain artificial trans fats and gave companies until January 2020 to remove all foods with PHOs from the food supply. And in May, the agency also denied a petition from the Grocery Manufacturers Association (GMA), requesting that FDA allow producers to use of PHOs is small quantities for specific and limited applications, such as pan release agents in baked goods.

“We’re also working on updating the definition of the claim 'healthy' on food labels, so it reflects current nutrition guidelines and to encourage its use,” Gottlieb wrote.

Reflecting the goals of its new strategy, FDA is planning to issue two proposed rules seeking to revoke the outdated standards of identity for French salad dressing and frozen cherry pie, which seeks to support FDA new plan to update the agency’s collection of nearly 300 standards of identity.

“This is a down payment on a comprehensive effort to modernize food standards to reduce regulatory burden and remove old-fashioned barriers to innovation,” Gottlieb wrote. “To support this effort, we’ll also reopen the comment period on a proposed rule seeking to establish general principles to update the framework for standards of identity.”

Many of FDA’s existing standards of identity have not been revised since they were first developed in the 1930s and 1940s, which has resulted in complaints from food manufacturers that the standards today do not reflect new technologies and methods of food production.

FDA and USDA recognized that in 2005 and issued proposed rule, outlining a set of general principles that the two agencies can use to create, revise or eliminate an existing standard. But that rule was never finalized and updating the standards was pushed to the back-burner until Gottlieb made a commitment this spring to revisit the issue.

While FDA has already started soliciting comments of the modernizing the standards through input on the Nutrition Innovation Strategy, it appears that FDA is also preparing a rule that would reopen the past joint efforts with USDA to address the issue.

“We are reopening the comment period because of the time that has elapsed since the publication of the proposed rule,” the agency explained in the recently released Unified Agenda. At this point, the agency said, “there have been additional technological advances and other changes in the food industry which could help inform the development of a modernized food standards framework.”

In addition to these nutrition-related actions, FDA’s agenda also features a few proposals related to implementation of the Food Safety Modernization Act (FSMA), including a proposed rule seeking to “make clarifying changes to general provisions related to the registration of food facilities rule, including edits to the definition of ‘farm,’” and deregulatory action proposal to streamline provisions within the Current Good Manufacturing Practice and Preventative Controls Rule for human food that require disclosure to commercial customers and receipt of written assurances.

The latter of these proposals would remove requirements that currently apply “when a manufacturer/processor of human food has identified a hazard that requires a preventive control but does not control that hazard.”

 FDA’s agenda also outlines a few proposed rules that the agency does not plan to finalize at this time, including a 2008 proposed rule that would have required owners or consignees to label imported food that was refused entry into the United States.

Advocates point to gaps, say agenda fails to list proposal to set disqualifying limits for added sugars

While the regulatory agenda overall stands in line with FDA’s recent work on nutrition and its new Nutrition Innovation Strategy, the agenda is raising concerns among CSPI advocates, at least one of whom believes FDA is placing greater focus on helping industry with regulatory burdens than on making significant steps to advance public health.

Laura McCleery, policy director at CSPI, noted that in both the agenda and Gottlieb’s post about it, there is heavy focus on modernizing food standards, which is mostly a problem for industry.

“There is a long way from the promises that we’ve heard out of FDA to use big-picture strategies to blunt the progress of diet-related disease and changes to the standards on French salad dressing,” she said. “That’s very steep diminution of FDA’s ambition, so I would hope that we see a lot more out of the agency than what’s promised on this regulatory agenda on positive changes to diet-related disease.”  

The Fall 2018 Unified Agenda is also notably missing a proposal that establishes disqualifying levels of added sugars for “health-like” claims on product labels, which is what FDA had promised to do in the Nutrition Facts panel rulemaking, MacCleery noted.

“Right now, you can’t make certain … claims that make a food look healthier if you have disqualifyingly high levels of sodium or saturated fat,” she said. “We think that’s important to ensure that foods that are marketed with a range of healthy claims also don’t have a high level of added sugars in them.”

“Now, they have a daily value for added sugar, they should be able to easily set what level of added sugars is too high to permit packages to make other kinds of nutrient content or other sort of claims,” she added.

“There is a long way from the promises that we’ve heard out of FDA to use big-picture strategies to blunt the progress of diet-related disease and changes to the standards on French salad dressing. That’s very steep diminution of FDA’s ambition, so I would hope that we see a lot more out of the agency than what’s promised on this regulatory agenda on positive changes to diet-related disease.” - Laura MacCleery, CSPI 


CSPI also has issues with a proposal on the agenda to permanently certify color additive lakes as safe, MacCleery added. To permanently certify artificial food coloring as safe would mean that these colorings would no longer have to undergo an annual safety review, she noted. And to permanently certify them, the agency would have to find that these colorings safe, which CSPI believes is in dispute, because research has suggested they may have behavioral effects that are harmful for susceptible children, MacCleery explained.

“We wrote a report on this a few years ago called Seeing Red that walked through this science,” she noted. “So, it’s disappointing that FDA would consider moving these things into permanent listing."

CSPI says delay of water provisions will weaken FSMA Produce Safety Rule

CSPI is also concerned about some of FDA’s planned regulatory action related to FSMA. On Friday (Oct. 19) one of the group’s advocates criticized the agency over its plans to finalize a rule that would delay compliance with the agricultural water provisions in FSMA’s Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule.

While FDA has already indicated that it plans to delay compliance with those provisions and the agenda item does not come as a surprise, Sarah Sorscher, CSPI’s deputy director for regulatory affairs, said consumer advocates vehemently oppose the change, as they fear it may diminish the benefits from FSMA’s Produce Safety Rule. “Our biggest concern is with the Produce Safety Rule,” said Sorscher on Friday as she discussed FSMA-related changes outlined in FDA’s latest six-month schedule.

Implementing the agricultural water provisions built into the Produce Safety rule is a crucial step for ensuring the safety of produce, especially because contaminated irrigation water has been identified as a major factor contributing to foodborne illness outbreaks, Sorscher said. “They are looking to weaken the rule. But if anything, the rule needs to be stronger,” she said. 

Water contaminated with animal feces caused a deadly outbreak of E.coli in Dole baby spinach in 2006 and now, twelve years later, FDA has found that another, equally deadly outbreak of E.coli in romaine lettuce was likely linked to contaminated canal water, Sorscher noted. 


Food Standards: General Principles and Food Standards Modernization (Reopening of Comment Period) (0910-AC54)

FDA has signaled it will reopen comments on a proposal for a set of standard principles that define how modern food standards should be structured. The proposal was developed in 2005 through a joint effort between FDA and USDA.

FDA now says it plans to solicit new comments on the proposal, as food technologies have evolved since the original proposal was developed.

Status: FDA plans to reopen the comment period for a proposed rule by June 2019. The action was originally proposed in 2005.

Nutrient Content Claims, Definition of Term: Healthy (0910-AI13)

FDA is proposing to redefine "healthy" to make it more consistent with current public health recommendations, including those captured in recent changes to the Nutrition Facts label.  The existing definition for "healthy" is based on nutrition recommendations that were developed in the 1990s, with a specific focus on individual nutrients to avoid (such as fat, saturated fat, cholesterol) as well as nutrients that Americans were not getting enough of at the time.

But nutrition recommendations have evolved since then, so FDA is looking to define “healthy,” as way to provide quick signals to consumers about the healthfulness of a food or beverage.

FDA is proposing to update the existing nutrient content “healthy” claim based on the food groups recommended by the Dietary Guidelines for Americans (DGA), while also including nutrients to limit to ensure the claim can help consumers build healthier diets and reduce their risk of diet-related chronic diseases.

Status: First time published in the Unified Agenda. A proposal is expected by March 2019.

Streamlining Provisions Requiring Disclosure to Commercial Customers and Receipt of Written Assurances From Commercial Customer is in Current Good Manufacturing Practice and Preventative Controls; Human (0910-AH77)

This proposal seeks to remove certain requirements that currently apply when a manufacturer/processor of human food has identified a hazard that requires a preventive control, but does not control that hazard.

If the proposal is approved, manufacturers and processors would no longer be required to obtain written assurance from the commercial customer that the identified hazard will be controlled. However, that manufacturer or processor would still be mandated to provide documentation that the food has not been processed to control the identified hazard.

Status: FDA expects to publish a proposed rule by December 2018. The proposal has appeared in the two previous agendas. In the spring, FDA had expected to develop the rule by Nov. 2018.

Laboratory Accreditation for Analyses of Foods (0910-AH31)

A critical component to nearly all of FSMA’s final rules, this proposed rule would establish a program for the testing of food by accredited laboratories, as well as a publicly available registry of accreditation bodies and accredited laboratories. The mandate will enable FDA to recognize accreditation bodies to ensure that laboratories use the appropriate equipment, personnel, and procedures to conduct reliable food analyses. A program for accredited laboratories will increase the number of qualified laboratories eligible to perform testing of food, which will help FDA improve the safety of the U.S. food supply.

Status: FDA expects to issue a proposed rule by November 2018, a slight delay from the last agenda’s goal of September 2018.

Permanent Listing of Color Additive Lakes (0910-AH80)

A proposal to streamline and clarify the regulations for color additive lakes (insoluble pigments prepared by chemically reacting water-soluble dyes with water-insoluble substances).  This proposed rule would consolidate 40 current regulatory provisions into three provisions, and permanently list certain color additive lakes as suitable and safe for use in foods, drugs, and cosmetics. The proposal would also prescribe conditions for the preparation of these lakes, allowing the use of more than one dye in a single lake.

Status: FDA expects to release a proposed rule by January 2019, a month later than the agency estimated in the spring agenda. In the Fall 2017 Unified Agenda, the proposal was slated for August 2018.

Amendments to Registration of Food Facilities (0910-AH82)

The proposed regulatory action would make clarifying changes to the registration of food facilities rule. Among the changes include edits to the definition of “farm” to better align how facilities and farms that perform similar activities are treated under the preventive controls and produce rules.

Status: FDA in expecting to develop a proposed rule April 2019, in line with the schedule laid in the last agenda.

Amendment to Add a New Method for the Analysis of Sulfites in Foods (0910-AI02)

This rule adds a second methodology that will improve the speed and efficiency in FDA testing for sulfites in food for enforcement activities.

Status: FDA expects to issue a proposed rule by March 2019, in line with the last agenda. The proposed rule was first listed on the agenda in the spring.

Proposed Rule to Revise the Allowable Level of Fluoride Added to Bottled Water (0910-AI03)

The proposal seeks to revise FDA’s quality standard regulations for fluoride in fluoridated bottled water to make them consistent with a 2015 recommendation for the U.S. Public Health Service for optimal fluoride concentration in community water systems. The proposal would not affect the allowable levels of fluoride in non-fluoridated bottled water, however.

Status: The proposal is slated for release in November 2018, several months after last agenda’s estimate of June 2018. The rule first appeared on the agenda in the spring.

Rule to Revoke Uses of Partially Hydrogenated Oils in Foods (0910-AI15)

A proposed rule that seeks to remove all mention of partially hydrogenated oils (PHOs) and revoke all prior sanctioned uses. The proposed rule would implement FDA’s findings that PHOs used in food may cause the food to be unsafe.

FDA first determined in 2015 that there was no longer a scientific consensus PHOs are generally recognized as safe (GRAS) for any use in human food. Later, in May 2018, the agency denied a food additive petition from the Grocery Manufacturers Association (GMA) requesting that the food additive regulations be amended to provide for the safe use of PHOs in certain food applications. And in June, FDA implemented the deadline for manufacturers to stop producing foods that contain PHOs.

Status: The proposed rule appears in the agenda for the first time and slated for release by June 2019.

French Dressing; Proposed Revocation of Standards of Identity (0910-AI16)

This proposal would amend FDA’s standard of identity regulations to remove the existing standard of identity requirements for the production of French dressing. If finalized, the action would provide manufacturers with greater flexibility in the production of those products.

Status: FDA expects to issue a proposed rule by May 2019. The proposal appears for the first time on the agenda.

Frozen Cherry Pie; Proposed Revocation of Standards of Identity (0910-AI17)

FDA is proposing to remove the standard of identity requirements at 21 CFR 152.126 for the manufacture of frozen cherry pies, which are the only fruit pies on the market for which FDA has a standard of identity. So, if finalized the proposed rule would provide food manufacturers with greater flexibility for production of such products.

Status: FDA expects to issue a proposed rule by May 2019. The proposal appears for the first time on the agenda.

The FDA Food Safety Modernization Act: Amendments to Exemption Provisions in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Regulation (0910-AI25)

FDA is proposing to revise certain requirements that currently apply to produce that satisfies criteria for an exemption from the produce safety regulation because that produce will receive commercial processing to adequately reduce the presence of microorganisms of public health significance.

Status: FDA expects to issue a proposed rule by December 2018. The proposal appears on the agenda for the first time.

Food Additives: Food Contact Substance Notification That Is No Longer Effective  (0910-AI01)

FDA is proposing to amend its food additive regulations to allow a Food Contact Substance Notification (FCN) to become no longer effective for reasons other than safety. Under the proposed rule, FDA would provide manufacturers or suppliers an opportunity to address any safety concerns earlier in the determination process.

Status: FDA plans to issue the proposed rule by March 2019, which is a three-month delay from the target release date in the last agenda.


Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods (0910-AH00)

The final rule would establish requirements for “gluten-free” labeling for foods that are fermented or hydrolyzed or that contain these ingredients for which there is no scientifically valid analytical method available that can reliably detect and accurately quantify the presence of 20 parts per million (ppm) gluten in the food.

Status: Final rule is expected by 2018, which represents not change from the last agenda.

Health Claims; Soy Protein and Coronary Heart Disease (0910-AH43)

A final rule seeking to amend FDA's regulation authorizing the use of health claims regarding the relationship between soy protein and coronary heart disease on the label or in the labeling of foods.

FDA plans to publish a proposed rule that revokes a 1999 regulation that authorized a health claim on the benefits of soy protein intake for reducing the risk of coronary heart disease (CHD).  The science supporting this claim no longer meets standards for FDA authorization, but there has been some evidence supporting a soy protein benefit on coronary heart disease.

Status: FDA hopes to develop a final rule by September 2019, which represents no change from the agency’s last agenda.

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, Extension of Compliance Dates for Subpart E       (0910-AH93)

This final rule would extend, for covered produce other than sprouts, the dates for compliance with the agricultural water provisions in the FSMA Produce Safety Rule. The extension would give FDA more time to address questions about the practical implementation of compliance with certain provisions and to consider how to reduce further the regulatory burden or increase flexibility for businesses affected by the rule.

Status: The final rule is expected to be ready for release November 2018, a few months after the June 2018 projected date in the last agenda.


Label Requirement for Food That Has Been Refused Admission Into the United States (0910-AF61)

A proposal issued in September 2008 that would have required owners or consignees to label imported food that was refused entry into the United States.

Status: FDA does not have plans to finalize the rule.


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