Ron Lanton 12/2/21 Ron Lanton 12/2/21

New Congressional Pharmacy Benefit Manager Bill Aimed at Spread Pricing Reintroduced

According to a December 1, 2021 press release, Representatives Carter (R-GA) and Gonzalez (D-TX) have reintroduced the Drug Price Transparency in Medicaid Act. The legislation “would limit the power of pharmacy benefit managers (PBMs) to artificially spike Medicaid drug prices. The Drug Price Transparency in Medicaid Act bans the use of spread pricing by middlemen (PBMs) in Medicaid managed care. PBMs drive up prescription drug costs without adding any value to the consumer.”

This legislation would help stop the under reimbursement that pharmacies are experiencing, while also helping to create much needed drug price transparency where Medicaid programs nationwide are concerned.

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. Our pharmacy practice has been helping pharmacies nationwide with operational issues, mergers and acquisitions, regulatory inquiries, audits, licensure, employment issues and contracting. Our lobbying efforts help pharmacies nationwide achieve improved business climates through carefully crafted legislation.

If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today.

Ron Lanton 11/23/21 Ron Lanton 11/23/21

CURES 2.0 Biomedical Legislation Introduced Into Congress

U.S. Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) are back as they recently introduced their long anticipated and bipartisan Cures 2.0 legislation. The bill is discussed via Congresswoman DeGette’s press release.

So what does this proposed legislation do:

Transform how Medicare covers innovative new treatments and technologies to make those new discoveries available to patients sooner.
Increase access to telehealth services for Medicare and Medicaid patients, including those covered under the Children’s Health Insurance Program, known as CHIP, to ensure more Americans are getting the help they need, when they need it.
Provide training and educational programs for at-home caregivers – including family members with no prior health care experience to help them better care for loved ones when they are home.
Require more diversity in clinical trials to ensure any new drugs and treatments approved for use in the U.S. are both safe and effective for a greater – and more representative – portion of the population.
Provide patients more information about the illness they face and the treatment options available to them to make them a more integral part of the decision-making process.
Conduct a nationwide study on the implications of long COVID; and
Develop a nationwide testing and vaccine distribution strategy to be used in future pandemics.

The proposed bill can be viewed here while a section by section summary can be viewed here.

Lanton Law is a national healthcare and life science boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments for our clients. Our life sciences practice can help stakeholders understand what’s at issue so that we can help our valued clients reach their goals. Contact us to learn about how either our legal or lobbying services can help you attain your goals.

Ron Lanton 11/19/21 Ron Lanton 11/19/21

Pharmacy Celebrates Another Win Over PBMs in the 8th Circuit

This week the 8th Circuit issued a decision in the case of Pharmaceutical Care Management Association v. Wehbi, which supported North Dakota’s legislative actions to regulate pharmacy benefit managers (PBMs). PCMA v. Wehbi is the first case at the federal appellate level since the landmark Rutledge v. PCMA decision last year that upheld Arkansas law also regulating PBMs.

The PCMA v. Wehbi case can be found here.

With these huge decisions serving as tailwinds for pharmacy there is still more work to be done.

Ron Lanton 11/16/21 Ron Lanton 11/16/21

Newly Introduced States Reform Act Proposes to End Current Federal Prohibition on Marijuana

Rep. Nancy Mace (R-SC) has introduced The States Reform Act, which is aimed at becoming the first prominent policy push by a House Republican to end the current federal prohibition on marijuana.

Rep Mace said the following regarding her legislation in a newly released press statement:

“Today, only 3 states lack some form of legal cannabis. My home state of South Carolina permits CBD, Florida allows medical marijuana, California and others have full recreational use, for example. Every state is different. Cannabis reform at the federal level must take all of this into account. And it’s past time federal law codifies this reality,”

“This is why I’m introducing the States Reform Act, a bill which seeks to remove cannabis from Schedule I in a manner consistent with the rights of states to determine what level of cannabis reform each state already has, or not.

“This bill supports veterans, law enforcement, farmers, businesses, those with serious illnesses, and it is good for criminal justice reform. Furthermore, a super-majority of Americans support an end to cannabis prohibition, which is why only 3 states in the country have no cannabis reform at all.

“The States Reform Act takes special care to keep Americans and their children safe while ending federal interference with state cannabis laws. Washington needs to provide a framework which allows states to make their own decisions on cannabis moving forward. This bill does that.”

The U.S. Department of Agriculture would oversee growers
The U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives would oversee the cannabis industry.
Medical marijuana would be regulated by the Food and Drug Administration,
There would also be a 3% federal excise tax on all cannabis products, where these proceeds would be reinvested in small businesses, mental health and law enforcement

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. Specifically we have expertise in cannabis and CBD related issues.

Ron Lanton 10/28/21 Ron Lanton 10/28/21

Rohit Chopra of the Consumer Financial Protection Bureau testified before the House Financial Services Committee on Changing Tech Stakeholder Influence

Rohit Chopra who is the Director of the Consumer Financial Protection Bureau testified before the House Financial Services Committee regarding how “Congress has tasked the CFPB with monitoring market conditions to spot risks, ensure compliance with existing law, and promote competition in order to protect families and honest businesses.”

He outlined the Bureau’s concerns with today’s tech and fintech market influences.

“Technological progress holds the potential for enormous benefits to households and the economy, particularly with respect to real-time consumer payments. At the same time, the desire of Big Tech to gain greater control over the flow of money in the economy raises a number of questions. For example, how will these firms harvest 2 and monetize data they collect on our transactions? What criteria will they use to decide who is removed from the platform? How will they ensure that payment systems adhere to consumer protections? Will Big Tech giants have an incentive to impede the entry of new firms seeking to offer competitive products and services? With this in mind, the CFPB has issued orders to dominant firms such as Facebook, Google, Apple, Amazon, Square, and PayPal to shed light on some of these questions. We will also be studying some of the practices of Chinese tech giants, including services provided by WeChat Pay and AliPay. These efforts complement other work within the Federal Reserve System to ensure families and businesses can rely on a fast and reliable payments system. It will also inform other initiatives to ensure that our evolving payments landscape is in alignment with our national interest. Given the state of today’s economic conditions, the Bureau also intends to ramp up its monitoring of other markets and their impact on specific population segments.”

Mr. Chopra’s testimony can be viewed here. Throughout the year we have seen where the fintech and technology stakeholder interests have begun to merge due to a changing marketplace.

Lanton Law is a national boutique regulatory law and lobbying firm that focuses on technology and healthcare/life science. If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today.

Ron Lanton 10/20/21 Ron Lanton 10/20/21

FDA Approves First Interchangeable Biosimilar for Humira

According to the FDA’s press release, “The U.S. Food and Drug Administration approved the first interchangeable biosimilar product to treat certain inflammatory diseases.”

According to the FDA’s press release, “The U.S. Food and Drug Administration approved the first interchangeable biosimilar product to treat certain inflammatory diseases. Cyltezo (adalimumab-adbm), originally approved in August 2017, is both biosimilar to, and interchangeable with (may be substituted for), its reference product Humira (adalimumab) for Cyltezo’s approved uses. Cyltezo is the second interchangeable biosimilar product approved by the agency and the first interchangeable monoclonal antibody. Once on the market, approved biosimilar and interchangeable biosimilar products can play a role in facilitating access to treatments for many serious health conditions.”

Furthermore, “The FDA granted approval of Cyltezo to Boehringer Ingelheim on October 15, 2021. To date, the FDA has approved 31 biosimilar products, including two interchangeable products, for a variety of health conditions.”

The FDA’s announcement can be viewed here.

This is an exciting announcement by the FDA, as competitors to the originator now have a viable path forward to make market inroads.

Ron Lanton 10/14/21 Ron Lanton 10/14/21

Antitrust Legislation Targeting Merger Filing Fees Passes Senate

U.S. Senator Amy Klobuchar (D-MN), Chair of the Senate Judiciary Subcommittee on Competition Policy, Antitrust, and Consumer Rights, and Senator Chuck Grassley (R-IA) who along with Senator Durbin (D-IL) as cosponsors have announced Senate passage of the Merger Filing Fee Modernization Act.

The bill which can be found here, proposes to “Promote antitrust enforcement and protect competition through adjusting premerger filing fees, and increasing antitrust enforcement resources.”

With a more aggressive FTC and a renewed emphasis on antitrust policy, commerce stakeholders should definitely pay attention to recent proposals on how to modify antitrust laws for the 21st century.

Ron Lanton 10/14/21 Ron Lanton 10/14/21

New Congressional Privacy Legislation Proposes Mandated Warrants to Search Americans’ Digital Devices at the Border

Senators Ron Wyden (D-OR) and Rand Paul (R-KY) have introduced the Protecting Data at the Border Act .

According to the press release “The bipartisan bill prevents law enforcement agencies from continuing to take advantage of the so-called border search “exception” in order to conduct warrantless searches of Americans’ phones and laptops.”

“The Protecting Data at the Border Act would provide statutory clarity by recognizing that the principles from Riley v. California extend to searches of digital devices at the border. In addition, this bill requires that U.S. persons know their rights before they consent to giving up online account information (like social media account names or passwords) or before they consent to give law enforcement access to their devices.”

The bill summary can be found here.

Lanton Law is a national boutique regulatory law and lobbying firm that focuses on technology and healthcare/life science. Our privacy practice monitors relevant policy and regulatory decision makers and we counsel clients on emerging trends within this rapidly developing field.

Ron Lanton 10/14/21 Ron Lanton 10/14/21

Senator Markey (D-MA) and Representatives Castor (D-FL) and Trahan (D-MA) Urge FTC To Use Authority to Make Tech Companies More Accountable

According to Senator Markey’s press release Senator Markey and Representatives Castor and Trahan have sent a letter to the Federal Trade Commission, urging the agency to use its full authority—including its authority under Section 5 of the FTC Act—to ensure these companies comply with their new policies. The Age Appropriate Design Code (AADC) took effect in the U.K. this September and requires online services available to children and teens to meet 15 key children’s privacy standards, many of which are similar to legislative proposals to update Senator Markey’s 1998 law, the Children’s Online Privacy and Protection Act (COPPA), in the United States.

It is no secret that technology stakeholders should be mindful of additional regulatory and policy scrutiny. Lanton Law is a national boutique regulatory law and lobbying firm that focuses on technology and healthcare/life science. We continue to monitor the policy and legal developments around the FTC.

Ron Lanton 10/8/21 Ron Lanton 10/8/21

California Enacts Genetic Privacy Legislation

On October 6th, California Governor Newsom (D-CA) signed SB 41 titled Privacy: genetic testing companies.

On October 6th, California Governor Newsom (D-CA) signed SB 41 titled Privacy: genetic testing companies. The bill can be viewed here. Below are the highlights of the bill:

This bill would establish the Genetic Information Privacy Act, which would require a direct-to-consumer genetic testing company, as defined, to provide a consumer with certain information regarding the company’s policies and procedures for the collection, use, maintenance, and disclosure, as applicable, of genetic data, and to obtain a consumer’s express consent for collection, use, or disclosure of the consumer’s genetic data, as specified.

This bill would require a direct-to-consumer genetic testing company to honor a consumer’s revocation of consent in accordance with certain procedures, and to destroy a consumer’s biological sample within 30 days of revocation of consent. The bill would further require a direct-to-consumer genetic testing company to implement and maintain reasonable security procedures and practices to protect a consumer’s genetic data against unauthorized access, destruction, use, modification, or disclosure, and develop procedures and practices to enable a consumer to access their genetic data, and to delete their account and genetic data, as specified. The bill would exclude from its provisions the California Newborn Screening Program, specific tests, and certain information, providers, entities, and activities subject to specified state and federal laws.

This bill would provide that the act does not reduce a direct-to-consumer genetic testing company’s duties, obligations, requirements, or standards under any applicable state and federal law for the protection of privacy and security and would further provide, if a conflict exists between the act and any other law, that the provisions of the law that afford the greatest protection for the right of privacy for consumers shall control.

This bill would impose civil penalties for a violation of those provisions, as specified. The bill would require actions for relief pursuant to these provisions to be prosecuted exclusively by the Attorney General, a district attorney, county counsel, city attorney, or city prosecutor, as specified, in the name of the people of the State of California upon their own complaint or upon the complaint of a board, officer, person, corporation, or association or upon a complaint by a person who has suffered injury in fact and has lost money or property as a result of the violation of the act. Because the bill would require local officials to perform additional duties, the bill would impose a state-mandated local program.

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology.

Ron Lanton 10/5/21 Ron Lanton 10/5/21

Biden Administration Issues Interim Final Rule on Surprise Medical Billing

The Centers for Medicare and Medicaid Services (CMS) in conjunction with the Departments of Health and Human Services (HHS), Labor (DOL), Treasury (collectively, the Departments), and the Office of Personnel Management (OPM) has issued an interim final rule with a comment period that seeks to implement the No Surprises Act aimed at surprise medical billing.

According to the CMS announcement “This rule details a process that will take patients out of the middle of payment disputes, provides a transparent process to settle out-of-network (OON) rates between providers and payers, and outlines requirements for health care cost estimates for uninsured (or self-pay) individuals. Other consumer protections in the rule include a payment dispute resolution process for uninsured or self-pay individuals. It also adds protections in the external review process so that individuals with job-based or individual health plans can dispute denied payment for certain claims.”

The interim final rule can be viewed here.

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology.

Ron Lanton 10/5/21 Ron Lanton 10/5/21

First Meeting of the President’s Council of Advisors on Science and Technology Occurs

The White House held the first meeting of the President’s Council of Advisors on Science and Technology Occurs (PCAST). PCAST deals with “1) U.S. competitiveness, security, and international science and technology leadership; and 2) U.S. public health and pandemic preparedness.”

The White House held the first meeting of the President’s Council of Advisors on Science and Technology (PCAST). PCAST deals with “1) U.S. competitiveness, security, and international science and technology leadership; and 2) U.S. public health and pandemic preparedness.”

“PCAST focused its meeting on two topics: U.S. competitiveness, security, and international science and technology leadership; and U.S. public health and pandemic preparedness. The meeting provided PCAST with an opportunity to hear from representatives of a broad range of sectors, including federal, state, and local governments, academia, and industry.”

Additional details on this meeting can be found here.

Lanton Law is a national boutique regulatory law and lobbying firm that focuses on technology and healthcare/life science. We continue to monitor the policy and legal developments around the FTC.

Ron Lanton 10/5/21 Ron Lanton 10/5/21

FTC Report to Congress on Privacy and Security

The Federal Trade Commission (FTC) last month issued the FTC Report to Congress on Privacy and Security.

What’s in the Report?

According to the agency “This report responds to the Joint Explanatory Statement accompanying the Consolidated Appropriations Act, 2021, P.L. 116-260, directing the Federal Trade Commission (“Commission” or “FTC”) to “conduct a comprehensive internal assessment measuring the agency’s current efforts related to data privacy and security while separately identifying all resource-based needs of the FTC to improve in these areas. The agreement also urges the FTC to provide a report describing the assessment’s findings to the Committees [on Appropriations of the House and Senate] within 180 days of enactment of this Act.”

Additionally, “The report first provides an overview of the FTC’s authority related to privacy and security, highlighting certain recent efforts in those areas. Second, it discusses priorities for improving the effectiveness of our efforts to protect Americans’ privacy. Third, it identifies areas in which we could use additional resources to further ensure Americans’ privacy is protected. Finally, it discusses the need for Congressional action on the FTC’s authority.”

Lanton Law is a national boutique regulatory law and lobbying firm that focuses on healthcare/life science and technology. We continue to monitor the policy and legal developments around the FTC.

Ron Lanton 9/27/21 Ron Lanton 9/27/21

Pharmacy Times Interviews Lanton Law On How COVID-19 May Lead to the Expansion of Practice Laws for Pharmacists Across the Country

Lanton Law PLLC was honored to speak with Medical World News’ Second Opinion on emerging COVID-19 vaccine mandates. It was great sharing this program with Ned Milenkovich of Much Shelist, P.C.

Episode 2 can be viewed here.

Lanton Law PLLC was honored to speak with Medical World News’ Second Opinion on emerging COVID-19 vaccine mandates. It was great sharing this program with Ned Milenkovich of Much Shelist, P.C.

Episode 2 can be viewed here.

Ron Lanton 9/24/21 Ron Lanton 9/24/21

SAFE Banking Act Passes House in Defense Legislation

The House of Representatives has passed by voice vote an amendment to the National Defense Authorization Act (NDAA) by adding the Secure and Fair Enforcement (SAFE) Banking Act to the legislation.

The House of Representatives has passed by voice vote an amendment to the National Defense Authorization Act (NDAA) by adding the Secure and Fair Enforcement (SAFE) Banking Act to the legislation. The bill would give safe harbors to financial institutions servicing cannabis industry stakeholders. The text of the SAFE Banking Act can be found here.

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. Specifically we have expertise in cannabis and CBD related issues.

Ron Lanton 9/20/21 Ron Lanton 9/20/21

New Request for Public Comment Regarding Technology Stakeholders

The Bureau of Industry and Security, Office of Technology Evaluation, U.S. Department of Commerce has issued a Notice of request for public comment. The notice is titled Notice of Request for Public Comments. According to the Bureau:

On February 24, 2021, President Biden issued Executive Order 14017 (E.O. 14017) on “America's Supply Chains,” which directs several federal agency actions to secure and strengthen America's supply chains. One of these directions is for the Secretary of Commerce and the Secretary of Homeland Security, in consultation with the heads of appropriate agencies, to submit, within one year of the date of E.O. 14017, a report on supply chains for critical sectors and subsectors of the information and communications technology (ICT) industrial base (as determined by the Secretary of Commerce and the Secretary of Homeland Security), including the industrial base for the development of ICT software, data, and associated services. This notice requests comments and information from the public to assist the Secretary of Commerce and the Secretary of Homeland Security in preparing the report required by E.O. 14017.

The comment deadline is November 4, 2021.

Lanton Law’s technology practice has been monitoring similar legislative and legal developments. If you are a technology or healthcare/life science stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today.

Ron Lanton 8/27/21 Ron Lanton 8/27/21

Lanton Law Speaks with Medical World News Second Opinion Regarding Mandated COVID-19 Vaccines

Lanton Law was honored to speak with Medical World News’ Second Opinion on emerging COVID-19 vaccine mandates. It was great sharing this program with Ned Milenkovich of Much Shelist, P.C.

The full episode can be viewed at: here.

Lanton Law PLLC was honored to speak with Medical World News’ Second Opinion on emerging COVID-19 vaccine mandates. It was great sharing this program with Ned Milenkovich of Much Shelist, P.C.

Episode 1 can be viewed here.

Ron Lanton 8/27/21 Ron Lanton 8/27/21

Home Infusion Stakeholders to be Helped by Newly Introduced Congressional Legislation

According to a press release by Senator Warner (D-VA), a newly introduced “bipartisan bill in the U.S. Senate proposes to ensure Medicare patients maintain access to home infusion therapies that require the use of an infusion pump. The Preserving Patient Access to Home Infusion Act — introduced by Sen. Mark Warner (D-VA) and Sen. Tim Scott (R-SC) — would ensure patients with serious viral and fungal infections, heart failure, immune diseases, cancer, and other conditions can receive the intravenous (IV) medications they need while at home.”

The Preserving Patient Access to Home Infusion Act can be viewed here.

How did this legislation come to be?

“Congress included provisions in the 21st Century Cures Act and the Bipartisan Budget Act of 2018 to create a professional services benefit for Medicare Part B home infusion drugs. The intent in establishing this benefit was to maintain patient access to home infusion by covering professional services including assessments, education on administration and access device care, monitoring and remote monitoring, coordination with the patient, caregivers and other health care providers, and nursing visits.

Despite Congress’ intent — as detailed in multiple letters to the agency — the Centers for Medicare and Medicaid Services (CMS) improperly implemented the benefit by requiring a nurse to be physically present in the patient’s home in order for providers to be reimbursed. As a practical matter, the current home infusion therapy benefit only acknowledges face-to-face visits from a nurse and fails to account for the extensive clinical and administrative services that are provided remotely by home infusion clinicians. As a result, provider participation in Medicare’s home infusion benefit has dropped sharply and beneficiaries have experienced reduced access to home infusion over the last several years.

The Preserving Patient Access to Home Infusion Act provides technical clarifications that will remove the physical presence requirement, ensuring payment regardless of whether a health care professional is present in the patient’s home. The legislation also acknowledges the full scope of professional services provided in home infusion — including essential pharmacist services — into the reimbursement structure.”

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. We have lobbied for and consult home infusion stakeholders.

If you are either thinking about getting into or are a current home infusion stakeholder and are unsure how your business model fares, contact Lanton Law so that we can go over your business model, assess potential risks and help you plan for both pending legislative and regulatory actions.

Ron Lanton 8/23/21 Ron Lanton 8/23/21

Oral Arguments Scheduled for North Dakota PBM Case

Oral arguments have been scheduled for September 1, 2021 at 2:00 PM CST for PCMA v. Wehbi. Earlier this year, the U.S. Supreme Court vacated this 8th Circuit case formerly known as Wilke v. PCMA.

A group of nine pharmacy associations have filed an amicus curiae (friend of the court) brief in the 8th Circuit matter known as PCMA v. Wehbi. This case is formerly known as Wilke v. PCMA. The amicus brief argues that ERISA does not preempt North Dakota PBM laws.

How did we get here? Last year (August) the 8th Circuit struck down contested North Dakota PBM laws due to ERISA. This is the argument that PBM attorneys advanced as a reason that the contested PBM laws in North Dakota could not stand. This decision was prior to the now landmark Rutledge case.

Surprisingly and much to the relief of the pharmacy community, the U.S. Supreme Court’s 2021 PCMA v. Rutledge decision determined that the 8th Circuit decision could not stand due to the Supreme Court’s Rutledge decision and its ERISA interpretations.

Oral arguments PCMA v. Wehbi have been scheduled for September 1, 2021 at 2:00 PM CST.

Ron Lanton 8/20/21 Ron Lanton 8/20/21

Latest FDA Refusal to Approve CBD as a Food Ingredient or Supplement Causes Stakeholder Frustration

The federal Food & Drug Administration (“FDA”) has refused to consider an application by Charlotte’s Web Holdings, Inc. (“Charlotte’s Web”) for a CBD product to be sold as a dietary ingredient. This decision was outlined in an FDA letter to the company found here.

“Under 21 U.S.C. § 350b(a), the manufacturer or distributor of a dietary supplement containing a new dietary ingredient that has not been present in the food supply as an article used for food in a form in which the food has not been chemically altered must submit to FDA, at least 75 days before the dietary ingredient is introduced or delivered for introduction into interstate commerce, information that is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such new dietary ingredient will reasonably be expected to be safe. FDA reviews this information to determine whether it provides an adequate basis for such a conclusion. Under 21 U.S.C. § 350b(a)(2), there must be a history of use or other evidence of safety establishing that the new dietary ingredient, when used under the condition recommended or suggested in the labeling of the dietary supplement, will reasonably be expected to be safe. If this requirement is not met, the dietary supplement is considered to be adulterated under 21 U.S.C. § 342(f)(1)(B) because there is inadequate information to provide reasonable assurance that the new dietary ingredient does not present a significant or unreasonable risk of illness or injury.

FDA has carefully considered the information in your notification and other available information and determined that your NDI 1202 cannot be used in dietary supplements pursuant to the dietary supplement exclusion provision in 21 U.S.C. § 321(ff)(3)(B) (section 201(ff)(3)(B) of the Act). The definition of a dietary supplement is set forth in 21 U.S.C. § 321(ff) (section 201(ff) of the Act), which states in relevant part:

(ff) The term ‘dietary supplement’ . . . (3) does . . . (B) not include – (i) an article that is approved as a new drug under section 355 of this title . . . or (ii) an article authorized for investigation as a new drug . . . for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public,

which was not before such approval . . . or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary's discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this chapter.

FDA has concluded that CBD products are excluded from the dietary supplement definition under 21 U.S.C. § 321(ff)(3)(B) (section 201(ff)(3)(B) of the Act).

We also conclude that, even if your NDI 1202 was not excluded from the definition of dietary supplement, the agency has concerns about the adequacy of safety evidence included in your submission as a basis for concluding that a dietary supplement containing NDI 1202 will reasonably be expected to be safe under the conditions of use described in your notification.”

Many in the industry were hoping to get some additional clarity on how FDA would oversee CBD and whether FDA’s views have evolved. Unfortunately that is not the case yet. CBD continues to be an item that has an uneven regulatory scheme.

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. Specifically we have expertise in cannabis and CBD related issues.

If you are either thinking about or are currently selling CBD and are unsure how your business model fares, contact Lanton Law so that we can go over your business model, assess potential risks and help you plan for both pending legislative and regulatory actions.