In the midst of continued enforcement regarding coronavirus marketing, FDA sent a warning letter to NeuroXPF concerning advertising for its CBD products alleging that they can boost immune systems to help consumers avoid contracting the virus. Citing the need to take “urgent measures to protect consumers” in the midst of the coronavirus outbreak, FDA advised NeuroXPF to remove claims indicating that the company’s products mitigate, prevent, treat, diagnose, or cure COVID-19.

NeuroXPF’s website included claims that consumers should “take CBD and take advantage of its potential to help prepare your body to fight a coronavirus infection.” According to the company, taking CBD “right now” “can help keep your immune system at the stop [sic] of its game.” NeuroXPF’s products had not, however, undergone the FDA’s new drug approval process.

Suggesting that NeuroXPF products can mitigate, prevent, treat, diagnose, or cure any disease, including coronavirus, without having undergone FDA new drug approval, makes the products unapproved drugs in violation of the FDCA, per the FDA.  NeuroXPF has 48 hours to email the agency detailing the steps the company has taken to correct any violations.

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As we’ve written about on our sister blog, Ad Law Access, federal and state regulators have been active in pursuing purveyors of scam products and price gougers.  For other helpful information during this pandemic, visit our COVID-19 Resource Center and our Advertising and Privacy Law Resource Center.

FDA took action earlier this week to relax regulatory standards for gowns, hoods, and surgeons’ and patient examination gloves during the pandemic.  The policy applies to the following products:

Table 1

Classification
Regulation
Device Type Product
Code6
Class
21 CFR 878.4040 Conductive Shoe and Shoe Cover BWP I (exempt)
21 CFR 878.4040 Operating-Room Shoes FXW I (exempt)
21 CFR 878.4040 Surgical Apparel Accessory LYU I (exempt)
21 CFR 878.4040 Non-surgical isolation gowns OEA I (exempt)
21 CFR 878.4040 Surgical suits FXO I (exempt)
21 CFR 878.4040 Operating-room shoe covers FXP I (exempt)
21 CFR 878.4040 Surgical helmets FXZ I (exempt)
21 CFR 878.4040 Surgical dress FYE I (exempt)
21 CFR 878.4040 Surgical caps FYF I (exempt)
21 CFR 878.4040 Surgical gown/toga FYA II
21 CFR 878.4040 Patient gown FYB II
21 CFR 878.4040 Surgical isolation gown FYC II
21 CFR 878.4040 Surgical hood FXY II

Table 2

Classification
Regulation
Device Type Product
Code
Class
21 CFR 880.6250 Patient examination glove FMC I (reserved)
21 CFR 880.6250 Latex Patient Examination Glove LYY I (reserved)
21 CFR 880.6250 Polymer Patient Examination Glove LZA I (reserved)
21 CFR 880.6250 Finger Cot LZB I (exempt)
21 CFR 880.6250 Vinyl Patient Examination Glove LYZ I (reserved)
21 CFR 880.6250 Powder-Free Guayle Rubber Examination Glove OIG I (reserved)
21 CFR 880.6250 Powder-Free Polychloroprene Patient Examination Glove OPC I (reserved)
21 CFR 880.6250 Radiation Attenuating Medical Glove OPH I (reserved)
21 CFR 880.6250 Specialty Patient Examination Glove LZC I (reserved)
21 CFR 878.4460 Surgeon’s Gloves KGO I (reserved)
21 CFR 878.4460 Powder-Free Non-Natural Rubber Latex Surgeon’s Gloves OPA I (reserved)

As it has for face masks and respirators, FDA is exercising enforcement discretion with respect to non-surgical gowns, surgical gowns, patient exam gloves, and surgeon’s gloves.  Provided that these items are marketed using labeling that expressly delineates the uses for which they are appropriate, warns against uses that may create excessive risk, meets applicable barrier protection/flammability/sterility standards, and does not indicate a use that may increase risk, FDA is relaxing standards for device registration and listing, premarket notification (where applicable), and quality system regulation compliance.  The guidance includes specific labeling criteria for each of these items.  The policy is effective immediately.

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For other helpful information during this pandemic, visit our COVID-19 Resource Center and our Advertising and Privacy Law Resource Center.

 

 

 

On March 25, FDA issued immediately effective guidance regarding its enforcement policy for face masks and respirators.  In light of widespread reports of mask and respirator shortages, the purpose of the guidance is to expand the availability of general use face masks for use by the general public, and of filtering facepiece respirators (N95 respirators) for use by health care professionals.  The guidance applies to the following products:

DA issued immediately effective guidance regarding its enforcement policy for face masks and respirators

FDA acknowledges that face masks and respirators are regulated by FDA when they meet the definition of a medical device and are intended for a medical purpose.  The intended use may be indicated by labeling indicated that the products that are intended for use by a health care professional or in a health care facility or environment.  It may also be indicated by inclusion of any drugs, biologics, or anti-microbial/anti-viral agents.

FDA Does Not Intend To Object To Use Of Non-FDA-Cleared Masks When FDA-Cleared Masks Are Not Available

However, FDA also acknowledges that these same products may be manufactured to the same specifications but not intended for use as a medical device.  Face masks and filtering facepiece respirators are marketed to the general public for non-medical purposes, such as use in construction.  Because these are non-medical uses, FDA does not have jurisdiction over these products.  The agency does not intend to object to individuals’ distribution and use of improvised PPE (a mask that is not FDA-cleared) when no FDA-cleared alternatives are available.

Face Masks (Not Respirators) That Are and Are Not Intended To Provide Liquid Barrier Protection

The guidance delineates specific conditions under which it will not object to the distribution of face masks (but not respirators) that are not intended to provide liquid barrier protection along with surgical masks intended to provide liquid barrier protection, e.g., required labeling and directions, compliance with consensus standards, and compliance with flammability standards.

Reprocessing FFRs and Emergency Use Authorizations (EUA) for Face Masks Intended For A Medical Purpose, Surgical Face Masks and N95 Respirators

The guidance also addresses EUAs of filtering facepiece respirators (FFR) and face masks intended for a medical purpose, surgical face masks and N95 respirators.  FDA is interested in interacting with manufacturers regarding reprocessing of otherwise disposable N95 particulate filtering facepiece respirators to facilitate marketing via an emergency use authorization.  The guidance lists specific reprocessing informational standards that FDA would find useful.

Further, regarding face masks intended for a medical purpose, surgical face masks, and N95 respirators, FDA is seeking to interact with manufacturers whose products do not fall within the prior EUAs to determine whether their products may be able to meet EUA requirements. The guidance lists specific informational elements that FDA would find useful in such discussions.

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For other helpful information during this pandemic, visit our COVID-19 Resource Center and our Advertising and Privacy Law Resource Center.

FDA issued updated guidance regarding manufacture of alcohol-based hand sanitizerAs reports of hand sanitizer shortages have circulated and consumers have taken to using even Tito’s Vodka as a replacement (yes, on their hands), FDA has stepped in to provide clarity.  Last Friday, FDA issued updated guidance regarding manufacture of alcohol-based hand sanitizer.

The first guidance document, Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19), is immediately in effect. It outlines that the agency does not intend to take action against manufacturing firms that prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs during this ongoing public health emergency, provided they comply with specific conditions, including the following:.

  1. The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:
  2. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20; or Isopropyl Alcohol (75%, v/v) in an aqueous solution.
  3. Glycerol (1.45% v/v).10
  4. Hydrogen peroxide (0.125% v/v).
  5. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients.

  1. The firm pays particular attention to ensure the ethanol or isopropyl alcohol active ingredient is correct and the correct amount of the active ingredient is used. A simple record should be used to document key steps and controls to assure each batch matches the formula developed for the drug product.
  2. The hand sanitizer is prepared under sanitary conditions and equipment utilized is well maintained and fit for this purpose.
  3. The firm uses the most accurate method of analysis available at the site for verification of alcohol content in samples of the finished drug product before each batch is released for distribution. Methods can include gas chromatography (GC), alcoholmeter, hydrometer, or other chemical analysis of at least equivalent accuracy.  The sample tested can be performed on in-process material before filling into the final containers to be distributed.
  4. The hand sanitizer is labeled consistent with the antiseptic monograph. Sample Drug Facts labels are included with the guidance.
  5. Firms register their facility and list these products in the FDA Drug Registration and Listing System.

In addition, FDA released a second guidance for pharmacies seeking to compound hand sanitizer.  The second guidance, Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency, is in effect for the temporary compounding of certain alcohol-based hand sanitizers by pharmacists in state-licensed pharmacies or federal facilities and registered outsourcing facilities.

Finally, on the medical device side, FDA has also expressed flexibility to undertake expedited reviews for manufacturers seeking to address PPE shortages.  Earlier this month, FDA released answers to frequently asked questions regarding the shortages of certain types of personal protective equipment (PPE).  FDA states that it may offer expedited review of submissions from manufacturers looking to produce PPE, especially surgical masks and gowns.  Interested parties can contact FDA per the FAQ.

For other helpful information during this pandemic, visit our COVID-19 Resource Center and  Advertising and Privacy Law Resource Center.

FDA Releases Industry Guidance Regarding Adverse Event Reporting During COVID-19On March 19, the Food and Drug Administration (FDA) released guidance providing recommendations to industry regarding postmarketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic, including COVID-19. The guidance revises and replaces final guidance released in 2012 entitled “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic.”

At bottom, the FDA recommends that companies should maintain normal adverse event reporting procedures as much possible during a pandemic. However, the guidance recognizes that a pandemic may lead to high levels of employee absenteeism that could delay submission. In such a case, the FDA advises that companies focus their limited resources on the following types of reports:

  • reports related to medical products indicated for the treatment or prevention of the pathogen causing the pandemic;
  • reports on products presenting special concerns as specified and communicated by FDA; and
  • other reports indicated Table 1 of the FDA guidance.

Where a company is able to report more than this minimum amount, the FDA advises that companies prioritize the order of reports. For example, companies should submit 15-day reports before 30-day reports, and should submit both before periodic safety reports.

In the event that adverse event reporting is delayed during a pandemic, the company should retain documentation of:

  1. the declaration of the pandemic, including date of declaration of the pandemic and ending date of the pandemic, and
  2. high absenteeism and/or other factors that prevent the company from meeting normal adverse event reporting requirements.

When business operations return to normal, the FDA expects that companies will submit any adverse event reports stored during the duration of the pandemic. The guidance states that companies should submit all reporting requirements within 6 months of restoration of the adverse event reporting process to its pre-pandemic state. Companies should submit stored reports in order of priority (e.g. 15-day reports first, then 30-day reports, followed by periodic safety reports.)

The guidance also recommends that companies create a continuity of operations plan (COOP) in the event of a pandemic. Such COOP should include instructions for reporting adverse events and provide a plan for the submission of any stored reports at the end of the pandemic. Companies can refer to the HealthCare Emergency Preparedness Information Gateway site, which provides resources for developing a COOP.

More resources on the FDA’s response to COVID-19 are available on its website here. We will continue to monitor for updates from the FDA regarding advice to industry. In the meantime, stay well!

For other helpful information during this pandemic, visit our COVID-19 Resource Center.

This week, the Food & Drug Administration (FDA) made a series of announcements in connection with its efforts to address the outbreak of COVID-19.  The Agency sought to reassure the American public that the U.S. food supply remains safe and that there is no evidence of food or food packaging being associated with the transmission of COVID-19.  The Agency also announced plans to scale back domestic and foreign food facility inspections and temporarily halt enforcement of supplier verification onsite requirements for receiving facilities and importers under the Food Safety Modernization Act (FSMA).

We’ll continue to monitor for updates and post them here.  More details follow on these and other FDA COVID-19 related developments.

  • Food safety, shortages, and COVID-19 transmission.  In a press conference on Wednesday, the Agency reiterated that the food supply is safe and robust, and that industry has reassured the Agency that current shortages in stores are indicative of heavy consumer demand and not an overall issue with food supply.  Also in a release and in FAQs from the Centers for Disease Control and Prevention (CDC) published on FDA’s website, the Agency noted that while “possible that a person can get COVID-19 by touching a surface or object that has the virus on it and then touching their own mouth, nose, or possibly their eyes,” this is not thought to be the primary way the virus is transmitted and “there is no evidence to support transmission of COVID-19 associated with food.”  As a result, FDA indicated that food does not need to be recalled or otherwise removed from commerce if a food industry employee tests positive for COVID-19.
  • Domestic food facility inspections.  Also on Wednesday, FDA announced that it would temporarily postpone all domestic routine surveillance facility inspections.  Some for-cause inspection assignments may proceed if determined to be “mission-critical,” and if there is a “way to get there to accomplish them in a way that does not put anyone at risk,” according to Michael Rogers, the assistant commissioner for human and animal food operations in the Office of Regulatory Affairs (ORA).  In a departure from current practice of conducting unannounced inspections, Mr. Rogers indicated that the majority of domestic inspections would be announced for the foreseeable future.
  • Supplier verification requirements.  On Tuesday, the Agency issued guidance announcing its intention to exercise enforcement discretion in connection with supplier verification onsite audit requirements for receiving facilities and importers.  These requirements derive from three separate rules promulgated to implement FSMA, the Preventive Controls for Human Food (PC Human Food) rulePreventive Controls for Animal Food (PC Animal Food) rule, and Foreign Supplier Verification Programs (FSVP) rule– and require receiving facilities and importers to conduct supplier verification activities based on the hazard analysis conducted as part of their written Food Safety Plan or FSVP.   The Guidance explained that FDA does not intend to enforce these requirements, provided the following criteria are met:
    • A receiving facility or FSVP importer has determined that an onsite audit is the appropriate verification activity for an approved supplier, as reflected by its written food safety plan or FSVP;
    • The supplier that is due for an onsite audit is in a region or country covered by a government travel restriction or travel advisory related to COVID-19;
    • Because of the travel restriction or travel advisory, it is temporarily impracticable for the receiving facility or FSVP importer to conduct or obtain the onsite audit of the supplier; and
    • The receiving facility or FSVP importer temporarily selects an alternative verification activity or activities, such as sampling and testing food or reviewing relevant food safety records, and modifies its food safety plan or FSVP to incorporate the alternative activity or activities. The alternative verification activity or activities are designed to provide temporary assurance that the hazard requiring a supply-chain-applied control (or, for FSVP, the hazard that is being controlled by the foreign supplier) has been significantly minimized or prevented during the period of onsite audit delay.
  • Foreign food facility inspections.  Earlier this month, FDA announced that it planned to postpone most foreign facility inspections through April.  The Agency plans to conduct “mission-critical” inspections on a case-by-case basis and work with the U.S. Customs and Border Protection to target products intended for importation into the U.S. that violate applicable legal requirements for FDA-regulated products.

The Agency has also emphasized that it has a strong partnership across public and private sectors and is coordinating daily with industry and other agencies.  FDA also noted that the food and agriculture sectors are classified as critical infrastructure for purposes of federal and state directives and thus employees should be able to continue to go to and from work in communities with curfews and shelter-in-place directives.  FDA urged food companies that experience any supply-chain problems to contact FEMA’s National Business Emergency Operations Center at NBEOC@fema.dhs.gov.

More resources on the FDA’s response to COVID-19 are available on its website here.

hat products they can use to disinfect their homes and offices to protect against the coronavirus that causes COVID-19With the ongoing spread of the coronavirus, and as stories of hording Purell and antimicrobial wipes abound, this practitioner* has been inundated recently by questions — from clients, co-workers, family, and friends — about what products they can use to disinfect their homes and offices to protect against the coronavirus that causes COVID-19.  Unfortunately, there is no shortage of unproven remedies being touted on websites and in mass emails, not to mention the rumor mill.  (*Remember, I’m a lawyer practicing in the antimicrobial regulatory field, not a medical doctor!)

The good news:  According to the U.S. Environmental Protection Agency (EPA) and the Centers for Disease Control and Prevention (CDC), coronaviruses are among the class of viruses that are the most easy for many disinfectant products to kill.  EPA’s “emerging pathogens” policy (more details of which can be found here in my prior blog post) establishes a three-tiered hierarchy of viruses according to how resistant they are to being killed (or “inactivated”) by typical disinfectant products.  “Enveloped viruses,” such as the coronavirus, are in the third tier, meaning that they “are the least resistant to inactivation by disinfection.”

The structure of these viruses includes a lipid envelope, which is easily compromised by most disinfectants. Once the lipid envelope is damaged, the integrity of the virus is compromised, thereby neutralizing its infectivity.   

EPA is now implementing its “emerging pathogen” policy and has issued a list of disinfectants that the agency believes to be effective against SARS-CoV-2 (the formal name of the novel coronavirus that causes COVID-19).  The EPA list is available here.

Typically, to be registered for use against a specific bacteria or virus, disinfecting/antimicrobial products must submit to EPA test data showing that the product is effective against that particular microbe.  EPA’s “emerging pathogens” policy was established to allow for the legal use of disinfectants against a novel virus for which no product would as yet have EPA approval and for which test data and methods may not exist.  The policy recognizes that a disinfectant that is effective against viruses in the same family as the novel virus, or which are effective against “harder to kill” viruses under the three-tier hierarchy noted above, should be effective against the new pathogen.

So, as a consumer, how does one know if a particular disinfectant for sale at the store (or, perhaps more likely in these quarantine days, for sale on-line) is likely to be effective against SARS-CoV-2?  Here are a few things to look for:

(1) Any legal disinfectant product must have an EPA registration number on the product label.  Look for “EPA Reg. No.” (followed by a series of numbers) in the fine print on the product label, usually near where other manufacturer or distributor information is provided. (Of course, not all registered disinfectants will be effective against the novel coronavirus, but to be legal it must at least have an EPA registration.)

(2) Check to see if that EPA Reg. No. is on the EPA list noted above.  However, as EPA is still working through submissions to include specific products on that list, there are others out there that may be effective, but just have not finished the expedited approval process for making coronavirus claims.

(3) Look for “coronavirus” in the list of microbes against which the product has been tested to be effective, as specified on the product label.  While no product labels as yet will state effectiveness against the SARS-CoV-2 novel coronavirus, they may have been tested for effectiveness against other coronaviruses (such as SARS and MERS).

(4) While on-product labels are not allowed to carry “emerging pathogen” claims, EPA’s policy allows registrants who meet certain criteria to provide information about effectiveness against an emerging pathogen on a product website, in social media, and in communications with health care professionals.  If the policy criteria are met, these products can include on such platforms a statement similar to the following:

Product X has demonstrated effectiveness against viruses similar to SARS-CoV-2/the novel coronavirus on hard surfaces. Therefore, Product X can be used against the novel coronavirus when used in accordance with the directions for use against [name of similar supporting virus(es)] on
hard surfaces. Refer to the CDC website for additional information.

Hope this is helpful and that everyone stays healthy and well-sanitized!

As the novel coronavirus (COVID-19) has reached pandemic levels, companies of all sizes and in all industries face myriad impacts to business operations and the health and well-being of employees.

To help clients navigate these new challenges, including the unpredictability of any outbreak-related business disruption, Kelley Drye has compiled a free resource center to help businesses navigate this uncertain environment.

Check it out for articles, webinars, and blog posts that cover a range of topics, including the following:

  • Legal exposure due to business interruptions and unsatisfied contracts, including counsel on contractual obligations, especially for significant business concerns.
  • Supply chain disruptions that are impacting the manufacture of consumer goods forcing manufacturers to seek alternative product sources that meet U.S. consumer regulations.
  • All types of employment issues, including how to communicate to your employees, managing affected employees, remote work policies, privacy of record and employee travel, among other pressing issues.
  • Evaluating disruptions to trading and markets, M&A/corporate transactions, commercial contracts, corporate governance (contingency planning for annual meetings) and disclosures for publicly traded companies.
  • Monitoring the federal government’s efforts to address these issues, as well as emerging issues that businesses may face.

We are updating the COVID-19 Resource Center as events unfold so check back regularly.

Greater than the Sum of Its Parts: FDA Releases Supplemental Draft Completing its Draft Guidance Regarding Protecting Food Against Intentional AdulterationFDA’s recently released Supplemental Draft Guidance entitled “Mitigation Strategies to Protect Food Against Intentional Adulteration:  Guidance for Industry” serves as a substantial supplement to the lengthy Revised Draft Guidance that FDA issued in March 2019 which shares the same title.[1]  Once finalized, these guidance documents will together serve to help covered companies comply with FDA regulations that require companies to have and implement a “food defense plan” (FDP) as a safeguard against intentional food adulteration risks.[2]

These FDA regulations implement provisions of the Federal Food, Drug and Cosmetic Act that result from the FDA Food Safety Modernization Act amendments. For businesses other than small and very small businesses, the compliance date for these regulations was July 26, 2019, but FDA has announced that it will not start routine inspections until March 2020.

FDA specifically describes the purpose of this guidance as helping covered entities develop and implement an FDP. The Revised Draft Guidance and Supplemental Draft Guidance together offer nine chapters, each addressing a specific consideration for developing an FDP. The following identifies the chapters introduced in both the Revised Draft Guidance and Supplemental Draft Guidance:

Revised Draft Guidance Supplemental Draft Guidance
Chapter 1: The Food Defense Plan Chapter 5: Mitigation Strategies Management Components: Food Defense Corrective Actions
Chapter 2: Vulnerability Assessment to Identify Significant Vulnerabilities and Actionable Process Steps Chapter 6: Mitigation Strategies Management Components: Food Defense Verification
Chapter 3: Mitigation Strategies for Actionable Process Steps Chapter 7: Reanalysis
Chapter 4: Mitigation Strategies Management Components: Food Defense Monitoring Chapter 9: Records
Chapter 8: Education, Training, or Experience

The Revised Draft Guidance and Supplemental Draft Guidance also include appendices that offer worksheets and assessments to aid covered entities with compliance efforts.

Interested parties have until June 15, 2020 to submit comments on this final round of guidance to ensure FDA will consider

_____________________________________

[1] Revised Draft Guidance. “Mitigation Strategies to Protect Food Against Intentional Adulteration:  Guidance For Industry” (March 2019)(revising and superseding draft guidance issued in June 2018), available at https://www.fda.gov/media/113684/download.

[2] 21 C.F.R. Part 121 (“Mitigation Strategies to Protect Food Against Intentional Adulteration”); Final Rule.  81 Fed. Reg. 34166 (May 27, 2016).

 

On the latest episode of the Ad Law Access Podcast, partner Kristi Wolff discusses FDA’s recent CBD warning letters, Commissioner nominee Dr. Stephen Hahn’s confirmation hearings, and a preview of this week’s Cannabis Law Update webinar.

On Thursday, December 5, from Noon – 1:00 Eastern we will be holding a webinar on the emerging cannabis regulatory and litigation landscape. This program will cover several areas, including the following:

  • Litigation trends
  • Prop 65 applicability
  • Trade and customs issues
  • What cannabis legalization means for government contractors

Register here: https://kelleydrye.zoom.us/webinar/register/WN_KnY4hTq-RVSpoLS7a7O4Xw

For additional information see the Cannabis Law Update blog.

The Ad Law Access podcast is available now through Apple PodcastsSpotifyGoogle PlaySoundCloud, and wherever you get your podcasts.