FDA ConneKTion

Timely updates and insights on the latest issues affecting FDA-regulated companies from Kilpatrick Townsend

Category: Food

Posted on Wednesday, July 12 2017 at 9:19 pm by
The Deadline for Submitting Comments to USDA as it Prepares to Draft a Proposed Rule on GMO Labeling is Quickly Approaching – Submit your Comments Now.

On June 28, 2017, the U.S. Department of Agriculture (USDA or agency) Agricultural Marketing Service (AMS) posted a list of 30 questions for consideration by stakeholders in order to assist the agency in developing a Proposed Rule setting national standards and procedures for the labeling of bioengineered foods  (i.e., GMO labeling).

As you may recall, AMS has two years to implement the National Bioengineered Food Disclosure Standards Law which was enacted by Congress on July 29, 2016, and charged the agency with developing a national mandatory system for disclosing the presence of bioengineered material in foods. The law also preempted future and existing state laws attempting to establish GMO labeling requirements for foods containing bioengineered materials. See our previous blog post on the Vermont GMO Law here.

With about a year left to publish a final rule (AMS is mandated to publish a final rule by July 2018), AMS is publishing this list of questions in the hopes that it will use any input to draft the proposed rule. The questions cover an array of topics from the terms that AMS should consider as interchangeable with “bioengineering,” to the text that manufacturers should be required to use when it chooses to use text to disclose a bioengineered food.

AMS is only providing stakeholders until Monday, July 17, 2017 to submit any comments.  Comments may be submitted to the following email address: GMOlabeling@ams.usda.gov.

Interested parties will also have an opportunity to submit any comments once a proposed rule is published by AMS. We will be closely following this rulemaking, as it may directly impact the compliance deadline for the new Nutrition Facts Label and Serving Size Final Rules published by the Food and Drug Administration in May 2016.  FDA recently indefinitely delayed the compliance date for these Final Rules (see our blog post here), and that decision may have been in part in order to avoid having industry update food labels twice within a short period of time.



Posted on Tuesday, June 13 2017 at 7:41 pm by
FDA Announces Intent to Extend Compliance Date for Changes to Nutrition and Supplement Facts Labels and Serving Sizes – Federal Register Notice to Follow “At a Later Date”


Following last month’s announcement that the Food and Drug Administration (FDA or agency) had decided to delay the compliance deadline for the menu labeling regulations (see our previous blog post here); today, the agency announced its intent to extend the compliance dates for the Nutrition and Supplement Facts Labels and Serving Size Final Rules.

As you may recall, in May 2016, the FDA issued Final Rules making the most significant changes to the food labeling regulations since they were initially adopted in 1993. The details of the changes are discussed in our May 27, 2016 blog post found here.  Since the Final Rules were published, the agency has been working on providing additional guidance to industry on how to implement the changes (e.g., changes with regard to dietary fibers).  However, in March of this year, the food industry sent a letter to U.S. Department of Health And Human Services Secretary, the Honorable Thomas E. Price, MD., expressing concern with the current compliance deadline of July 2018 for manufacturers with more than 10 million dollars in annual food sales (and July 2019 for those with less than 10 million dollars), and requesting it be extended until May 2021, arguing that the current timeframe for implementation did not “sufficiently account for the time, resources, and complexity involved in label changes of this magnitude.”

After several months of speculation as to whether the Agency and its new Commissioner would be delaying the compliance dates for the new Final Rules, FDA announced that after careful consideration, it had determined that “additional time would provide manufacturers covered by the rules with necessary guidance from FDA, and would help them be able to complete and print updated nutrition facts panels for their products before they are expected to be in compliance.”

While the FDA will be issuing a Federal Register Notice outlining the details of the extension “at a later time;” it noted that “the framework for the extension will be guided by the desire to give industry more time and decrease costs, balanced with the importance of minimizing the transition period during which consumers will see both the old and the new versions of the label in the marketplace.”

Given that the U.S. Department of Agriculture (USDA) is mandated to issue GMO labeling rules in the near future, it is possible that FDA will delay the changes to the nutritional facts labels to coincide with those rules ( potentially until 2021) in order to avoid having industry update their labels twice.  However, we will need to wait until that future Federal Register Notice to see what the agency decides to do.


Posted on Friday, May 5 2017 at 8:53 pm by
Compliance Deadline For Menu Labeling Regulation Postponed Due To Implementation Challenges; Further Request for Comments

By: Alyson L. Wooten, Pharm.D.

For those anxious about today’s compliance date for Food and Drug Administration’s (FDA) regulations governing calorie labeling, the compliance deadline has been postponed. FDA has again decided to delay the compliance date for its regulations governing calorie and other nutritional labeling for menus and menu boards at restaurants and similar establishments.  The new date for compliance is May 7, 2018.

Cohen_Simms_FDA_menu_labelingThe additional year is necessary to allow the Agency to reconsider aspects of the regulations to “further reduce the regulatory burden or increase flexibility while continuing to achieve our regulatory objective.”[i]  Further, the Agency stated that “continued, fundamental questions and concerns with the final rule suggest that critical implementation issues, including some related to scope, may not have been fully understood and the agency does not want to proceed if we do not have all of the relevant facts on the matters.”[ii]

The final rule (79 FR 71156; codified at 21 C.F.R. § 101.11) had an original compliance date of December 1, 2014, which was later extended to July 10, 2015 (80 FR 39675), and ultimately to December 30, 2016 (81 FR 96364).

As part of this extension of time, FDA is seeking additional comments regarding the compliance date extension, implementation of the final rule, and three “fundamental issues that continue to pose significant implementation challenges:”[iii]

  • Calorie disclosure signage for self-service foods, including buffets and grab-and-go foods;
  • Methods for providing calorie disclosure information other than on the menu itself, including how different kinds of retailers might use different methods; and
  • Criteria for distinguishing between menu and other information presented to the consumer.

The deadline to submit comments is July 3, 2017.

[i] https://www.federalregister.gov/documents/2017/05/04/2017-09029/food-labeling-nutrition-labeling-of-standard-menu-items-in-restaurants-and-similar-retail-food

[ii] Id.

[iii] Id.



Posted on Thursday, April 6 2017 at 8:19 pm by
A Roundup of Some of the Latest FDA News . . . . From DUNS Numbers to Cosmetics

By: Carolina M. Wirth

It is no secret that since the Trump Administration took over in late January, the Food and Drug Administration (FDA or agency) has been quieter than usual with regard to guidance documents and Federal Register Notices most likely due to President Trump’s 2-for-1 Executive Order and the lack of a Commissioner.  However, the ties seem to be slowly turning and we are starting to see a bit more activity from FDA.  Of course, we expect that things will pick up as soon as the agency gets a new Commissioner and FDA refocuses its priorities for the next few years.  In the meantime, below is a roundup of a couple of the latest publications recently issued by the Agency. Read the rest of this entry »

Posted on Monday, March 20 2017 at 6:47 pm by
FDA’s Public Meeting on the Use of the Term “Healthy” in the Labeling of Human Food Products – Summary and Major Takeaways

By Carolina M. Wirth

On March 9, 2017, the Food and Drug Administration (FDA or Agency) held a public meeting in Rockville, MD, which FDA officials described as a way to engage in a dialog with the public and regulated industry and allow for opportunity to ask questions on how to redefine the term “healthy.” In the opening remarks, FDA noted that the food landscape has shifted from being “nutrient-focused” to more of a “food-based” focus, and that the current regulation for the use of the term “healthy” was issued in the early 1990s at a time when food science was focused on limiting total fat intake and on ensuring that consumers were able to meet certain nutritional deficiencies that were identified to be of concern at that time (e.g., Vitamins C and A).

As science has evolved, the focus has shifted from total fat reduction to encouraging consumers to eat certain types of fats and deficiencies in Vitamin D and potassium intake. With the modernization of the Nutrition Facts panel and serving size regulations to reflect more current science, FDA is seeking to, among other things, determine how to align the use of the term “healthy” with those recent changes.

The first part of the public meeting consisted of two panel discussions that focused on consumer attitudes, beliefs, and behavior and provided stakeholders with an opportunity to share their perspectives on how “healthy” should be defined. The second half of the meeting consisted of breakout sessions covering the following three topics: 1) Healthy as a nutrient-based claim; 2) Healthy as a food component-based claim; and 3) Consumer meaning and understanding of the term Healthy. The meeting ended with presentations from interested members of the public and industry. Read the rest of this entry »

Posted on Friday, February 17 2017 at 9:42 pm by
FDA to Hold Public Meeting to Discuss the Use of the Term “Healthy” in Food Labeling

 ucm505353By Carolina M. Wirth

The Food and Drug Administration (FDA or agency) announced this week that it will be hold a public meeting on March 9, 2017, from 8:30 a.m. to 5:30 p.m., to discuss the use of the term “healthy” in the labeling of food products.  As you may remember from our previous blog post, FDA issued a Federal Register Notice on September 28, 2016 inviting public comment on the term “healthy” generally, and as a nutrient content claim in the context of food labeling.   FDA was also seeking input on several specific questions.[i]

Following the FDA’s extension of the comment period until April 26, 2017, the public meeting will provide participants with an additional opportunity to engage in an open discussion about the use of the term “healthy.”  Specifically, interested parties will be able to provide information, share experiences and raise issues specifically related to the nutrient content claim “healthy,” including (but not limited to): “healthy” as a nutrient-based claim, food component-based claim, or both; “healthy” single definition or definition by category; consumer understanding of and responses to the term “healthy”; and when, if ever, the use of the term “healthy” may be false or misleading.

The public meeting will include an “introductory presentation, perspective panels, and multiple opportunities for individuals to express their opinions at the meeting through oral presentations, participation in breakout sessions, and submission of electronic or written comments.[ii]”  FDA will publish the agenda and other documents before the public meeting on its website.[iii]

FDA is encouraging interested parties to register early online to attend in person because space is limited.  Anyone interested in making an oral presentation must submit a request to the agency by February 21, 2017.  As noted above, FDA will continue to accept electronic or written comments on this topic until April 26, 2017.


[i] See Federal Register Notice entitled, Use of the Term ‘‘Healthy’’ in the Labeling of Human Food Products; Request for Information and Comments, 81 Fed. Reg. 66,562 (September 28, 2016), available at https://www.federalregister.gov/documents/2016/09/28/2016-23365/use-of-the-term-healthy-in-the-labeling-of-human-food-products-request-for-information-and-comments.

[ii] See Federal Register Notice entitled “Use of the Term ‘Healthy’ in the Labeling of Human Food Products; Public Meeting; Request for Comments, 82 Fed. Reg. 10,868 (February 16, 2017), available at https://www.federalregister.gov/documents/2017/02/16/2017-03117/use-of-the-term-healthy-in-the-labeling-of-human-food-products-public-meeting-request-for-comments.

[iii] The agenda and other documents will be accessible at http://www.fda.gov/Food/NewsEvents/WorkshipsMeetingsConferences/default.htm.


Posted on Wednesday, January 25 2017 at 8:19 pm by
Decoding New FDA Nutrition And Supplement Facts Guidance (Published by Law360)

Food-labelsHappy New Year 2017!   In early January, the Food and Drug Administration issued guidance on complying with new final rules amending the nutrition facts label regulations.  Here is my recent Law360 article which summarizes the key points of the guidance document: Decoding New FDA Nutrition And Supplement Facts Guidance.

Posted on Wednesday, December 14 2016 at 11:05 pm by
FDA Makes Public the Scientific Data Evaluated and Provides Draft Guidance Regarding the Inclusion of Certain Fibers in the Definition of Dietary Fiber

By: Alyson L. Wooten, Pharm.D.

getty_rm_photo_of_whole_grain_breakfast_nutritionAs previously reported here, in May 2016, the Food and Drug Administration (FDA or agency) published new final regulations on Nutrition and Supplement Facts labeling.  As part of the final rules, FDA defined “dietary fiber,” in relevant part, as “non-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units), and lignin that are intrinsic and intact in plants; isolated or synthetic non-digestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human health.”[i]  The final rule identified only 7 isolated or synthetic fibers that met this definition.[ii]  Under the prior method of identifying “dietary fibers” for labeling (which involved analytical methods for measuring levels of fiber present), there were many other types of isolated or synthetic non-digestible carbohydrates that manufacturers routinely declared as dietary fiber on Nutrition Facts labels.  In drafting the final regulations, FDA indicated that there was insufficient evidence of a beneficial physiologic effect for other previously considered dietary fibers to be included in the definition, but indicated that anyone could provide evidence to support the addition of other dietary fibers through the Citizen Petition process.  This immediately led to questions about what data had been reviewed and the standard the agency would apply to determine beneficial physiological effects.

Read the rest of this entry »

Posted on Tuesday, November 8 2016 at 7:55 pm by
“Nutella” No Longer Just a Dessert Topping – FDA Seeks Comments on Appropriate Reference Amount Customarily Consumed (RACC) and Product Category for Flavored Nut Butter Spreads

By: Carolina M. Wirth

As we previously reported, the Food and Drug Administration (FDA) issued a Final Rule in May of this year updating, modifying and establishing several reference amounts customarily consumed (RACCs) for a number of foods based on new consumption data showing that the amount of food consumed by Americans has changed since 1993.  In that Final Rule, the Agency recognized the need for a RACC for hazelnut spreads “outside of the dessert product category” and agreed that the “primary usage of hazelnut spread is as a spread for bread instead of as a dessert topping.”[1]  At the time, because the proposed rule did not address this issue, and because the Agency intended to provide an opportunity for the public to comment, FDA noted that it intended to “consider whether to move hazelnut spread to a different appropriate product category in a future rulemaking.”[2]

8a17fd49-134d-408a-a1e4-668c1200a01bMoving forward with that intent, on November 2, 2016, FDA started the rulemaking process by establishing a docket to receive comments, data, and other information on the appropriate RACC amount and product category for flavored nut butter spreads (e.g., cocoa, cookie, and coffee flavored) and products that can be used to fill cupcakes and other desserts, such as cakes and pastries.  In the Federal Register Notice, FDA noted that it was taking this action for two reasons: (1) the Final Rule updating certain RACCs, and (2) a Citizen Petition asking the Agency to either “issue a guidance recognizing that “nut cocoa-based spreads” fall within the “Honey, jams, jellies, fruit butter, molasses” category for purposes of RACC determination; or amend the regulation to establish a new RACC category for “nut cocoa-based spreads’ with an RACC of 1 tablespoon (tbsp.).”[3]  FDA also took this action in response to a request to establish a RACC and product category for cupcake filling.[4]

Read the rest of this entry »

Posted on Saturday, October 1 2016 at 1:57 pm by
FDA Seeks to Redefine the Term “Healthy” and Questions Whether this Could Help Consumers Make Better Food Choices

By: Carolina M. Wirth

Getting consumers to make informed food choices and encouraging the food industry to develop healthier foods continues to be a priority for the Food and Drug Administration (FDA) as the Obama administration comes to an end. After publishing a Final Rule updating the Nutrition Facts panel and serving sizes for some foods for the first time in over 20 years in May[1] of this year, FDA is now turning to redefining the term “healthy” as a nutrient content claim.

Currently, FDA regulations (21 C.F.R. § 101.65(d)) establish parameters for the use of the implied nutrient content claim “healthy” on the labeling of a food to suggest that the food, because of its nutrient content, may be useful in creating a diet that is consistent with dietary recommendations.[2]  The parameters include (1) specific criteria for nutrients to limit in the diet, such as total fat, saturated fat, cholesterol, and sodium; and (2) requirements for nutrients to encourage in the diet, including vitamin A, vitamin C, calcium, iron, protein, and fiber.[3]  While the nutrient criteria for using the term “healthy” can vary for different food categories, they are specifically linked to the elements in the Nutrition Facts panel and serving size regulations.[4]

Read the rest of this entry »