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Posted on Tuesday, February 13 2018 at 7:05 pm by -

Will Kratom Be Restricted?

By: Alyson L. Wooten, Pharm.D.


Kratom, a popular alternative medicine used as a home remedy for opioid addiction, is now classified by the Food and Drug Administration (“FDA”) as an opioid – a step that may lead to the classification of the substance as a restricted drug under the Controlled Substance Act.

Kratom-e1518403746740-600x350Kratom lies at the intersection of the debate between natural product and drug of abuse. Thousands of people around the world have taken kratom, which grows naturally in areas of tropical Southeast Asia. The plant is part of the coffee family and is commonly crushed for use as an herbal supplement and traditional remedy for pain relief and as a stimulant.

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Posted on Friday, December 22 2017 at 9:08 pm by -

FDA Proposes a New Risk-Based Enforcement Approach for Certain Categories of Homeopathic Drug Products

By Carolina M. Wirth

More than 2 years after the Food and Drug Administration (FDA or agency) held a public hearing to obtain input from both the public and industry stakeholders regarding its current regulatory framework for homeopathic drug products, the agency has issued a draft guidance proposing a new, risk-based enforcement approach for drug products labeled as homeopathic.  Following the public hearing, FDA received more than 9,000 comments in response to its request for “broad public feedback on its enforcement policies related to drug products labeled as homeopathic.”[1]

According to FDA, after considering the information obtained from the public hearing, as well as the comments submitted to the public docket, it determined that

it is in the best interest of the public health to issue a new draft guidance that proposes a comprehensive, risk-based enforcement approach to drug products labeled as homeopathic and marketed without FDA approval.[2]

While the draft guidance provides a risk-based enforcement framework for products labeled as homeopathic, it leaves open the question as to how the agency will address the marketing of homeopathic drug products in the future considering that the draft guidance, when finalized, will withdraw FDA Compliance Policy Guide (CPG) 400.400, Conditions Under Which Homeopathic Drugs May be Marketed,[3] which was issued by the agency in 1988.
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Posted on Friday, September 22 2017 at 8:51 pm by -

Menu Labeling Litigation Between the FDA and Public Interest Groups May Be On Hold

By: Alyson L. Wooten, Pharm.D.

Following the 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), two public interests groups sued the FDA over the decision seeking to have the delay vacated and an immediate compliance date ordered.  Both of these groups, the Center for Science in the Public Interest (CSPI) and the National Consumers League (NCL), have agreed to stay the litigation if FDA will issue additional guidance before the end of the year and confirm that it will not provide another extension to the deadline.

CSPI and NCL sued FDA in June shortly after FDA extended the deadline for compliance asserting that the extension of time was unlawful because the Agency did not provide a rational explanation for the delay or provide for public comments before the delay took effect. In August, the government filed a motion to dismiss for lack of jurisdiction.  A few days later, on August 25, the Agency issued a statement that they would issue “additional guidance” about menu labeling before the end of the year and that the new guidance “should allow covered establishments to implement the requirements by next year’s compliance date.”

On September 15, prior to the deadline for Plaintiffs to file an opposition to Defendant’s motion to dismiss, the parties (CSPI, NCL and FDA) filed a joint motion to stay the case. If granted by the court, the case will be stayed until May 7, 2018, as long as the FDA issued new their guidance by the end of the year and confirmed a compliance date with the Menu Labeling Rule by no later than May 7, 2018.  If FDA does not confirm May 7, 2018 as the compliance date, gives any indication that the compliance deadline could be or will be extended beyond May 7, 2018, or fails to publish the additional guidance before the end of the year, the stay may be lifted and the litigation will proceed with “expedited consideration.”  However, the parties agree that if the compliance date goes into effect on May 7, 2018, the parties will dismiss the case.

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Posted on Tuesday, July 25 2017 at 2:24 pm by -

FDA Issues New Guidance on IRB Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations

By: Carolina M. Wirth

As July comes to an end, the Food and Drug Administration (FDA or agency) has issued a new guidance document for “immediate implementation” entitled “IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More than Minimal Risk to Human Subjects.”  The guidance document outlines FDA’s new enforcement policy with regard to IRB waivers or alterations of informed consent requirements for certain minimal risk clinical investigations.

According to FDA, the agency has received numerous inquiries over the years “from sponsors and investigators about conducting important minimal risk clinical investigations for which obtaining informed consent was not practicable[i].” However, FDA did not have the statutory authority to allow for a waiver of informed consent for these types of investigations until the recent passing of the 21st Century Cures Act (Cures Act).

The Cures Act, which was signed into law on December 13, 2016, amended the Federal Food, Drug and Cosmetic Act and provided FDA with the authority to “permit an exception from informed consent requirements when the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject.[ii]”  Currently, FDA regulations only allow an exception from the informed consent requirements in life-threatening situations (21 CFR 50.23) or for emergency research (21 CFR 50.24).  Thus, FDA intends to publish regulations to reflect this statutory change, including any appropriate human subject protection safeguards.

Until the new regulations are published, FDA does not “intend to object to an IRB approving a consent procedure that does not include, or that alters some or all the element of informed consent set forth in 21 CFR 50.25,” as long as the IRB finds and documents that:

  • The clinical investigation involves no more than minimal risk (as defined in 21 CFR 50.3(k) or 56.102(i)) to the subject;
  • The waiver or alteration will not adversely affect the rights and welfare of the subjects;
  • The clinical investigation could not practicably be carried out without the waiver or alteration; and
  • Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

According to FDA, it intends to “withdraw th[e] guidance after [it] promulgate[s] regulations to permit a waiver or alteration of informed consent under appropriate human subject protection safeguards consistent with Section 3024 of the Cures Act.[iii]”  However, the agency does not provide a timeframe for when it plans to issue these regulations.  In the meantime, while the guidance is for immediate implementation, the agency “will consider all comments received and will revise this guidance when appropriate.[iv]


[i] Guidance at 1.

[ii] Guidance at 2.

[iii] Guidance at 4.

[iv] Guidance at 2.

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 Wednesday, June 14 2017 at 3:26 pm by -

U.S. Supreme Court Finds that Dancing with Biosimilars is NOT Mandatory

By: Alyson L. Wooten, Pharm.D.

imagesThe U.S. Supreme Court had a busy day on Monday (June 12, 2017) issuing four unanimous decisions in recently argued cases.  Of particular note is the final decision in the Supreme Court’s 2016 term – the consolidated case of Sandoz Inc. v. Amgen Inc. and Amgen Inc. v. Sandoz Inc., which interpreted the Biologics Price Competition and Innovation Act (BPCIA).  As we reported here, this case originated out of the U.S. District Court for the Northern District of California where Amgen sued Sandoz for failure to engage in the BPCIA’s patent dance[1] and for inadequate notice of commercial marketing of Sandoz’s biosimilar version (Zarxio®) of Amgen’s Neupogen® product.

The Supreme Court decided that Sandoz had not violated the BPCIA by failing to engage in the patent dance. The justices found it compelling that the BPCIA expressly sets forth the consequences for failure to provide a copy of the FDA application and manufacturing information as required under 42 U.S.C. § 232(l)(2)(A).  This initial exchange of information sets into motion the patent dance.  The consequences, found in 42 U.S.C. § 232(l)(9)(C), permit the sponsor to bring an immediate declaratory judgment action for patent infringement.  Thus, the Supreme Court found the BPCIA does not require a biosimilar applicant to share its abbreviated biologics application and associated data, and, in the absence of voluntary sharing, a branded biologics developer must use injunctive relief to enforce its patents.  As such, the Supreme Court determined there is no requirement that a biosimilar applicant participate in the patent dance.  However, the Court remanded to the Federal Circuit to determine whether California state law may provide for injunctive relief to enforce 42 U.S.C. § 232(l)(2)(A) based on failure to comply with California’s unfair competition statute.

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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 Thursday, June 8 2017 at 8:25 pm by -

FDA Extends the UDI Compliance Date for Certain Class I and Unclassified Devices

By: Carolina M. Wirth

UpdateWith the deadline for compliance with the unique device identification system[i] (UDI system) requirements for certain Cass I and unclassified devices other than implantable, life-supporting, or life-sustaining devices (i.e., lower risk devices) over 3 years away (September 24, 2020), the Food and Drug Administration (FDA or agency) issued a letter on June 2, 2017, expressing its intend to extend the compliance date for these types of medical devices until September 24, 2022. In the letter, the FDA acknowledged that there have been some challenges associated with the implementation of the UDI requirements.

Specifically, the agency noted that

after fully considering the time needed to meet UDI requirements, many labelers asked FDA for extensions to comply. In addition, [the agency] identified complex policy and technical issues that need resolution such as how UDI applies to products such as medical procedure trays that contain implantable devices and instruments.  Providing accurate and timely support to labelers has also been challenging due to the sheer number and wide diversity of devices.

In addition to these concerns, FDA noted that in order to “fully reap the public health benefits and a return on investment of a UDI system, high quality UDI data must be available in standardized ways so that the health care community can and will use it with confidence.”

FDA plans to issue a guidance document outlining an enforcement discretion[ii] policy for labeling Global Unique Device Identification Database (GUDID) data submission, standard date formatting, and direct marking requirements for class I and unclassified devices as indicated in the table below.  The agency did not provide a date for when this guidance document will be available to the public and regulated community.

Type of Device Label (21 CFR 801.20), GUDID Submission (21 CFR Part 830, subpart E), and Standard Date Format (21 CFR 801.18) Requirements Direct Mark (21 CFR 801.45) Requirements


Class I devices[iii] September 24, 2020 September 24, 2022
Unclassified devices September 24, 2020 September 24, 2022

[i] The FDA published a Final Rule establishing a UDI system designed to allow adequate identification of devices throughout distribution and use on September 24, 2013.

[ii] Enforcement discretion will not apply to class I or unclassified implantable, life supporting or life-sustaining devices because labelers of these types of devices must already be in compliance with the UDI requirements.

[iii] Class I CGMP-exempt devices are excepted from the UDI requirements per 21 CFR 801.30(a)(2).

Posted on Thursday, May 11 2017 at 8:34 pm by -

New FDA Commissioner Scott Gottlieb, M.D. Sworn in Today

By Carolina M. Wirth

As many of you know, Scott Gottlieb, M.D. was confirmed by the Senate (57 to 42) on Tuesday, May 9, 2017, to serve as the 23rd Commissioner of the Food and Drug Administration (FDA or agency).   Today, he was officially sworn in as Commissioner and begins the task of leading the FDA.

drscottgottlieblHere are a few facts about the FDA’s new Commissioner:[i]

  • Dr. Gottlieb is a physician, medical policy expert, and public health advocate.
  • He previously served as FDA’s Deputy Commissioner for Medical Scientific Affairs and as Senior Advisor to the FDA Commissioner.
  • He worked on the implementation of the Medicare drug benefit when he served as a Senior Advisor to the Administration of the Centers for Medicare and Medicaid Services.
  • He was appointed by the Senate in 2013 to serve on the Federal Health Information Technology Policy Committee, which advises the Department of Health and Human Services on Healthcare Information Technology.

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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.