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.


[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

[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

[iii] The agenda and other documents will be accessible at


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 Friday, December 23 2016 at 5:12 pm by

FDA Recommends Maximum Level of Lead in Cosmetic Products . . . But Finds that Most Products Surveyed are Already Well Below the Recommended Levels


By Carolina M. Wirth

As 2016 comes to an end, the Food and Drug Administration (FDA or agency) is turning its attention to cosmetics by issuing a draft guidance on December 21, 2016 recommending a limit of “no more than 10 parts per million (ppm) of lead as an impurity in cosmetic lip products (such as lipsticks, lip glosses, and lip liners) and externally applied cosmetics (such as eye shadows, blushes, compact powders, shampoos, and body lotions).[i]”  This is the first guidance since 2014,[ii] that the agency has published involving cosmetics.  The draft guidance is in part a response to a 2011 Citizen Petition by the Personal Care Products Council (PCPC) requesting that the FDA establish a limit of 10 ppm for lead in lipsticks and other types of externally applied cosmetics.  After completing its own testing of cosmetics products and conducting exposure analysis, the FDA decided to grant the PCPC’s Petition.  The draft guidance does not apply to “topically applied products that are classified as drugs or to hair dyes that contain lead acetate as an ingredient.[iii]

Read the rest of this entry »

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 Friday, October 21 2016 at 6:56 pm by

Forty Years in the Making — FDA Issues Propose Rule Requiring Electronic Submission of Labeling and Package Inserts for Class II and Class III Home-Use Medical Devices

By: Carolina M. Wirth

This past summer, the Food and Drug Administration (FDA or Agency) celebrated the 40th anniversary of the enactment of the Medical Device Amendments of 1976, which in part amended Section 510(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to add requirements for the registration of device manufacturers and the listing of medical devices.  As enacted, the statute also required that the listings be accompanied by copies of the device label.[1]   However, because the registration and listing information was required to be provided in paper form for many years, FDA did not enforce the requirement that medical device establishments submit labeling information because “there was no practical way for FDA to compile, update, or access the information submitted on these forms, much less provide routine public access to the information.”[2]  Therefore, FDA decided to require by regulation that medical device manufacturers maintain a historical file of labels, labeling, and advertisements for restricted devices, and “make all or part of that file available to FDA upon request.”[3]  This practice has remained in place since a final rule was issued in 1978.

In 2002, Congress began to recognize the impact of the internet when it passed the Medical Device User Fee and Modernization Act, providing FDA with the authority to collect registrations and listings “at such time as FDA determined it was feasible . . . . through electronic means.”[4]  Amendments to the Medical Device User Fee Modernization Act in 2007 finally made the submission of registration and listing information by electronic means mandatory in all instances, unless a waiver is granted by the Agency.

Now, almost 10 years after the requirements for electronic submission of registration and listing information, FDA is issuing a Proposed Rule amending its regulations to require the electronic submission of the label and package insert for certain “home-use” medical devices when the devices are listed with FDA.[5]  The Proposed Rule defines a “home-use” medical device as “a medical device that is labeled for use in any environment outside a professional health care facility.”[6]  The types of “home-use” devices that would be subject to the Proposed Rule, if finalized, are those that are regulated by FDA as Class II or Class III devices, which are considered moderate-to-high risk medical devices.[7]

Read the rest of this entry »

Posted on Thursday, October 13 2016 at 6:53 pm by

FDA’s Hatch-Waxman Regulations Get a Long Overdue Update

By: Alyson L. Wooten, Pharm.D.

On December 5, 2016, twenty-two (22) pages of new Hatch-Waxman regulations will be codified in the Code of Federal Register. These new regulations bring several significant changes to the Hatch-Waxman landscape, which has been largely unchanged for over a decade.

The Final Rule,[1] titled “Abbreviated New Drug Applications and 505(b)(2) Applications” (Final Rule) was published in the Federal Register twenty (20) months after the Food and Drug Administration (FDA or Agency) published the Proposed Rule, which outlined Agency’s plan for implementing portions of Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA).[2]

Specifically, the Final Rule implements portions of the MMA that pertain to:

  • Notices provided to the patent owners and the new drug application (NDA) holder for certain patent certifications made in 505(b)(2) applications or ANDAs;
  • The availability of 30-month stay of approval for 505(b)(2) applications or ANDAs that are otherwise ready to be approved;
  • Submission of amendments and supplements to 505(b)(2) applications and ANDAs; and
  • The types of bioequivalence and bioavailability data that may be used to support 505(b)(2) applications or ANDAs.

Read the rest of this entry »

add_filter('wp_headers', 'cdfie_add_header');