Category: Government Affairs

FDA Issues 15 New Warning Letters to CBD Companies and Publishes Consumer Update

By: Adam S. Bloom, Esq. and John E. Morrone, Esq.

On November 25, 2019, the Food and Drug Administration (FDA) issued warning letters to 15 companies selling cannabidiol (CBD) and published a revised Consumer Update broadly detailing its safety concerns regarding CBD products. In addition, the FDA said it intends to provide an update “in the coming weeks” on its progress towards developing a regulatory approach to CBD products.

Each of the companies that received warning letters sold their products online in “interstate commerce.”  The products sold include a wide range of CBD products including oils, creams, tinctures, capsules, dietary supplements, human foods (such as gummies and chocolates) and animal foods. As has been the case in each of their previous CBD-related warning letters, the FDA focused its attention on companies that market CBD products with claims that the products cure, mitigate, treat or prevent diseases such as cancer, diabetes, opioid addiction, schizophrenia, multiple sclerosis, autism, Crohn’s disease, depression, and arthritis.

Although each of the targeted companies made illegal disease claims, the FDA made it a point to emphasize that the CBD foods (including animal foods) and dietary supplement products were in further violation of the Food, Drug and Cosmetic Act (FDCA). The FDA stated it is illegal to introduce into interstate commerce human or animal food containing CBD because CBD is an unapproved food additive – it is not Generally Recognized as Safe (GRAS) among qualified experts, and no food additive regulation authorizes its use in foods. The FDA also noted that CBD cannot be marketed as a dietary supplement because it does not meet the definition of a dietary supplement under the FDCA.

Additionally, the FDA emphasized its concern with the marketing of CBD products to children. For example, they called out a CBD product named “Asteroid Gummies” which was advertised with the claim that consumers can give the product “as a treat to your kid[.]”

Significantly, in the revised Consumer Update, the FDA conveyed its belief that there are many unanswered questions and data gaps about CBD safety and that the limited data it has seen regarding CBD point to “real risks.” The FDA’s safety concerns regarding CBD include potential liver injury, the effect of interactions with other drugs, drowsiness, diarrhea, changes in mood, effects on male reproductive health, impact on vulnerable populations such as children and pregnant or breast-feeding women, and the cumulative effects of CBD use.

In an FDA press release issued in conjunction with the warning letters and the revised Consumer Update, the FDA Principal Deputy Commissioner Amy Abernathy, M.D., Ph.D., emphasized that they are monitoring the CBD marketplace and will take action against companies that “violate the law in ways that raise a variety of health concerns.” She added that FDA believes there are “knowledge gaps” about the science, safety, and quality of many CBD products and that the FDA is concerned that people wrongly believe many CBD products have been evaluated by the FDA and determined to be safe or that trying CBD “can’t hurt.”

By issuing 15 new warning letters and articulating its concerns regarding CBD safety, FDA has reiterated its commitment to overseeing the CBD industry and demonstrated the risks of marketing CBD products without a thorough understanding of the unsettled and complex CBD regulatory environment. If you need assistance navigating the regulatory environment for CBD or other cannabis-derived products, contact Frier Levitt today to speak with an attorney.

USDA Establishes Hemp Regulatory Framework

By: Adam S. Bloom, Esq. and John E. Morrone, Esq.

On October 29th, 2019, the U.S. Department of Agriculture (USDA) released an interim final rule establishing a national regulatory framework for domestic hemp cultivation. The interim rule is intended to facilitate and expand production and sales of domestic hemp and marks a major milestone in the establishment of a nationwide hemp industry.

The interim rule creates baseline requirements for hemp production but allows states and Native American tribes to establish more restrictive plans, subject to USDA approval. If a state does not implement its own plan, the USDA plan will apply. Also, notably, the rule prohibits states and tribes from banning the interstate transport of hemp that has been legally grown under the program.

The interim rule includes requirements regarding collecting and maintaining relevant information on the land used for hemp production; procedures for sampling and testing to ensure the cannabis grown and harvested does not exceed the acceptable hemp THC level (no greater than 0.3% THC concentration level on a dry weight basis); procedures for ensuring effective disposal of plants exceeding the acceptable hemp level; compliance procedures to ensure hemp is being produced in accordance with applicable requirements including conducting annual inspections and procedures for handling violations; and procedures for reporting specific requirements to the USDA.

The USDA also issued guidelines for sampling and testing procedures for hemp. Samples, which have to be collected approximately two weeks prior to a crop’s anticipated harvest date, must be tested at Drug Enforcement Administration (DEA)-registered laboratories.

There is a 60-day comment period during which interested persons may submit comments on the interim rule. After reviewing and evaluating the comments, USDA will draft and publish a final rule within two years.

Federal and state laws regarding hemp, CBD, and other cannabis-derived products are rapidly evolving and there are many potential pitfalls for operating in these markets without a thorough understanding complex regulatory environment for such products. If you need assistance navigating the regulatory environment for hemp, CBD or other cannabis-derived products, contact Frier Levitt today to speak with an attorney.

The FDA and FTC issue Warning Letter to Florida CBD Company for Unsubstantiated Disease Claims and Marketing to Children

On October 10, 2019, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued a joint warning letter to Florida-based Rooted Apothecary, LLC, for selling cannabidiol (CBD) products with unsubstantiated claims that the products treat or cure a variety of serious diseases and health conditions, including claims that the products treat certain conditions in infants. The warning letter reflects the FDA’s continuing concern over CBD products marketed for therapeutic or medical uses, and emphasizes the FDA’s concern over CBD products marketed for use by infants and/or children.

The FDA found various products marketed by Rooted Apothecary to be unapproved new drugs because the company’s website and its social media website included claims that the products are intended to diagnose, cure, mitigate, treat or prevent diseases including Parkinson’s, Alzheimer’s, depression, anxiety, PTSD, attention deficit/hyperactivity disorder (ADHD), cancer, and diabetes.

In addition, the FDA found that Rooted Apothecary unlawfully marketed certain CBD products as dietary supplements. As noted in previous warning letters, the FDA considers products containing CBD to be excluded from the definition of dietary supplements because CBD is the active ingredient in the FDA-approved drug Epidiolex, and CBD was not marketed as a dietary supplement or conventional food prior to the authorization of the clinical investigations of Epidiolex.

The FDA was particularly concerned that Rooted Apothecary markets certain CBD products to infants and children. For example, the company claimed that the “Teeth/TMJ – Essential Oil + CBD Infusion” product will “help calm the inflammation and pain of teething, while also promoting sleepiness for your little one.” The “Ears – Essential Oil + CBD Infusion” product included the claim, “We formulated this for the entire family including our precious little ones.” Further, the company’s website included webpages with statements such as “CBD oil . . . seems like an attractive and safe option for children” and “children can use high amounts of CBD safely and without any risk.”

Regarding the warning letter, Acting FDA Commissioner Ned Sharpless, M.D., said, “We are working to protect Americans from companies marketing products with unsubstantiated claims that they prevent, diagnose, treat or cure a number of diseases or conditions. This is especially concerning when companies are peddling unproven CBD products for use in vulnerable populations like infants and children.” Dr. Sharpless added, “We’ve sent numerous warning letters that focus on matters of significant public health concern to CBD companies, and these actions should send a message to the broader market about complying with FDA requirements.”

The FTC warned Rooted Apothecary that it is concerned that the company lacks the requisite “competent and reliable scientific evidence” to substantiate claims that its products can prevent, treat or cure human disease.

This latest warning letter from the FDA and FTC again highlights the potential pitfalls of marketing CBD products without a thorough understanding of the unsettled and complex regulatory environment for such products. If you need assistance navigating the regulatory environment for CBD or other cannabis-derived products, contact Frier Levitt today to speak with an attorney.

Federal Trade Commission Issues New Warning Letters for CBD Products

On September 10, 2019, the Federal Trade Commission (FTC) issued warning letters to three unidentified companies that sell cannabidiol (CBD) products with claims that the products treat or cure serious diseases or health conditions. The warning letters send a message to the CBD industry that any such claims must be supported by sound scientific data.  Specifically, FTC requires competent and reliable scientific evidence to support any claims that a product prevents, treats or cures a medical condition.

One company claimed that its CBD product relieves pain better than prescription opioid painkillers, and was “clinically proven” by “thousands of hours of research” to treat cancer, Alzheimer’s disease, multiple sclerosis, fibromyalgia and colitis.

A second company claimed that its CBD products are proven to treat a litany of serious diseases including autism, anorexia, schizophrenia, ALS, stroke, Parkinson’s disease, Crohn’s disease and AIDS.

The third company claimed its CBD gummies were highly effective in treating “the root cause of most major degenerative diseases, including arthritis, heart disease, fibromyalgia, cancer, asthma, and wide spectrum of autoimmune disorders” along with various other serious conditions.

FTC warned these companies that selling CBD products without competent and reliable scientific evidence substantiating their claims could violate the FTC Act and may result in legal action resulting in penalties including injunction and the return of money to consumers.

These warning letters echo the March 2019 warning letters sent jointly by FTC and the Food and Drug Administration warning companies against making disease claims without adequate substantiation.

This latest round of warning letters highlights the potential pitfalls of marketing CBD products without a thorough understanding of the unsettled and complex regulatory environment for such products. If you need assistance navigating the regulatory environment for CBD or other cannabis-derived products, contact Frier Levitt Government Affairs to speak with an attorney.

FDA Announces it is Expediting Review of CBD

On July 12, 2019, Food and Drug Administration (FDA) Principal Deputy Commissioner Dr. Amy Abernathy announced via Twitter that the FDA is expediting its work to address the regulation of cannabidiol (CBD). She stated that FDA intends to report on its progress “around end of summer/early fall.”

Dr. Abernathy added that the FDA is enthusiastic about research into the therapeutic benefits of CBD products but reiterated the need to balance safety concerns. She also acknowledged the intense interest around this issue by saying that in addition to the over 100 speakers who presented at the May 31 FDA public hearing on cannabis products, there have been 3,417 comments submitted to the public docket (with four days remaining before the July 16 deadline).

Congress has also recently pressed the FDA for expedited action on CBD regulation. Senator Ron Wyden, D-Ore., sent the FDA a letter on June 25 urging the FDA to promptly issue guidance that ensures a regulatory pathway for the lawful use of hemp-derived CBD as a food additive and as an ingredient in dietary supplements. He called for FDA to issue an “enforcement discretion guidance” by August 1.

On the other side of the aisle, Senator Mitch McConnell, R-KY, met with Acting FDA Commissioner Dr. Ned Sharpless on June 28 and urged him to develop regulations to allow hemp-derived CBD to be lawfully marketed.

The House also recently passed an amendment to appropriations legislation directing FDA to “undertake a process to make lawful a safe level for conventional foods and dietary supplements containing [CBD] so long as the products are compliant with all other FDA rules and regulations.”

The emerging CBD industry creates opportunities for current participants in the drug supply chain, physicians, and other healthcare providers. However, anyone either currently involved in marketing or providing CBD products or those desiring to get into the CBD market should engage qualified guidance. Frier Levitt Government Affairs and Frier Levitt are committed to the healthcare industry and can provide sage advice to providers. Contact us today.

HHS Announces New Payment Models Impacting Nephrology Stakeholders

Blog: HHS Announces New Payment Models Impacting Nephrology Stakeholders

President Trump has signed an Executive Order that directs the Department of Health and Human Services (HHS) to develop new nephrology policies to address reducing the number of patients developing kidney failure, increasing the number of kidneys available for transplant, and reducing the number of dialysis treatment at dialysis centers to encourage more in-home kidney dialysis. These policies will take shape in via five new CMS Center for Medicare and Medicaid Innovation payment models.

According to HHS, “the proposed required End-Stage Renal Disease (ESRD) Treatment Choices (ETC) Model would encourage greater use of home dialysis and kidney transplants for Medicare beneficiaries with ESRD in order to preserve or enhance their quality of care while reducing Medicare expenditures, and the Kidney Care First (KCF) and Comprehensive Kidney Care Contracting (CKCC) Models will test new Medicare payment options that aim to improve the quality of care for patients with kidney disease.”

Additionally, CMS announced four optional models:

  • The Kidney Care First (KCF) Model
  • The Comprehensive Kidney Care Contracting (CKCC) Graduated Model
  • CKCC Professional Model
  • The Global Model

These optional payment models are designed to help health care providers reduce the cost and improve the quality of care for patients with late-stage chronic kidney disease and ESRD. These models also aim to delay the need for dialysis and encourage kidney transplantation.

Healthcare and life sciences stakeholders can expect to continue to see policy changes for the foreseeable future so it is better to be prepared ahead of time before they happen. Frier Levitt Government Affairs (FLGA) monitors and forecasts issues of importance for healthcare and life sciences stakeholders, including state and federal legislation and regulation, all presented in a concise, easy to understand and time friendly format. FLGA’s monitoring and forecasting services allow stakeholders to stay educated and engaged on new developments before the trends become mainstream.

With laws and regulations changing all the time, it is imperative for healthcare and life sciences stakeholders and organizations to be proactive instead of reactive. Contact FLGA today to get “in the know” and finally be prepared for the changes ahead.

FDA Extends Comment Period on Products Containing Cannabis

The FDA has announced a notice of a comment period extension. The FDA originally solicited the industry in an April 3, 2019 notice, seeking comments to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.

In addition to establishing a docket for public comment from its May 31, 2019 public hearing on the issue, the FDA has now extended its comment period until July 16, 2019.

If you are interested in submitting comments to the docket or need assistance navigating the unsettled and complex regulatory environment for cannabis-derived products including CBD, Frier Levitt Government Affairs and Frier Levitt, LLC can help. Contact us today.

FDA Conducts Anticipated Hearing on the Regulation of CBD Products

On May 31, 2019, the Food and Drug Administration (FDA) held a widely anticipated public hearing to gather information on the use of cannabis and cannabis-derived compounds, including cannabidiol (CBD), in consumer products such as foods, dietary supplements and cosmetics. Although FDA did not reveal any new regulatory pronouncements, the hearing marks an important initial step in the Agency’s on-going evaluation of a potential evidence-based regulatory pathway for such products.

At the hearing, Acting Commissioner Dr. Ned Sharpless delivered opening remarks and reiterated that recent changes to federal and state law, and the explosion of CBD products in the marketplace, have not affected FDA’s view that CBD cannot be lawfully added to any FDA-regulated consumer product. While the Agriculture Improvement Act of 2018 (the “Farm Bill”) generally legalized CBD derived from hemp (defined as cannabis with THC content below 0.3% by dry weight), the Farm Bill explicitly preserved FDA’s authority to regulate foods, drugs, dietary supplements and cosmetics containing CBD. Dr. Sharpless said critical questions remain about the safety of widespread CBD use and the Agency will carefully evaluate whether evidence supports the broad use of CBD in FDA-regulated products.

Echoing his predecessor Dr. Scott Gottlieb, Dr. Sharpless noted that FDA is primarily concerned with over-the-counter CBD products that claim to prevent, diagnose, mitigate, treat or cure serious diseases such as cancer. While FDA enforcement to date has focused on CBD products making egregious disease claims, Dr. Sharpless noted that FDA does not have a policy of enforcement discretion with respect to any CBD products.

Over 100 people testified at the hearing from a broad range of interest groups including academia, health professionals, agriculture, manufacturers, retailers, distributors, consumer groups, patients, state governments, public safety organizations, and legal professionals. Speakers discussed a wide array of uses for CBD products and provided anecdotal and scientific conclusions regarding CBD use. Several speakers described the current CBD market as the ‘Wild West’ and emphasized the need for instituting quality assurance and good manufacturing standards. Many speakers also addressed the difficulty of testing CBD products in the current legal environment and how that hinders the creation of quality CBD products.

Comments to the FDA docket may be submitted until July 2, 2019.

If you need assistance navigating the unsettled and complex regulatory environment for cannabis-derived products including CBD, or if you are interested in submitting comments to the docket, contact Frier Levitt Government Affairs today.

Service Spotlight: Forming a Political Action Committee (PAC): What the Healthcare and Life Sciences Stakeholders Need to Know

With the 2020 political season quickly approaching, healthcare and life sciences industry stakeholders have started showing interest in forming Political Action Committees (PACs).

A Political Action Committee or (PAC) is organized for the purpose of raising and spending money to either help candidates elected or defeated. These organizations represent industrial or ideological interests and are regulated under either state or federal campaign finance laws depending on the PAC’s usage.

PACs continue to be influential under the right guidance. Stakeholders that are more aggressive in advancing their political agendas have found that the use of PACs are effective in getting their respective messages out. Frier Levitt Government Affairs helps organizations create PACs and provides ongoing consultation regarding compliance, policy recommendations, and other strategic suggestions to help organizations achieve their respective goals.

Contact Frier Levitt Government Affairs today to learn more about how you can use a PAC to increase your political influence.

Massachusetts Releases PBM Transparency Report

The Massachusetts Health Policy Commission has released its analysis of state PBM activity titled, Cracking Open the Black Box of Pharmacy Benefit Managers. Notably, the report concludes the need for additional PBM oversight and scrutinized the practice of PBM spread pricing.

According to the report, PBM spread pricing practices appear to be increasing in Massachusetts: “…this practice covered 22% of PBM compensation in 2014, but rose to 54% in 2016. This practice, often used as a means of payment for PBM services instead of administrative fees, may have significant impacts on public insurance programs, employer health plans, and consumers. Additionally, the media has reported growing concerns from pharmacists about low reimbursement rates from PBMs in Massachusetts and other states. PBM payments to pharmacies are sometimes even below the pharmacy’s acquisition costs of the drugs, which can affect the financial viability of pharmacies and potentially impact access to care. Yet the extent to which PBMs profit from this practice, and on which drugs, remains largely hidden from payers and the public.

Additionally, the Commission cited, “As part of the fiscal year 2020 state budget strategy on MassHealth drug prices, the Baker-Polito administration proposed a new requirement for PBMs to be transparent about their pricing and to limit PBM margins under contracts with MCOs and accountable care organizations (ACOs), which the administration projects will save $10 million. To advance transparency, MassHealth recently released a bulletin directing MCOs and MassHealth Accountable Care Partnership Plans to obtain and submit to MassHealth drug-specific data from their PBMs including payments to dispensing pharmacies and rebate and administrative payment data.”

Based on recent activities and discussions with Massachusetts, additional PBM policies are forthcoming. Frier Levitt Government Affairs’ (FLGA) forecasting and monitoring services help keep healthcare and life sciences stakeholders “in the know” regarding pending policy and marketplace changes. Forecasting and monitoring helps stakeholders make better strategic decisions so that they no longer just “reacting” to outside changes. Contact FLGA today for forecasting and monitoring services tailored for you and your organization.