Tag: Food and Drug Administration

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.

Service Spotlight: Engaging in Regulatory Comments to Protect Company Operations & Margins

Proposed regulations are something that are underutilized by healthcare and life sciences supply chain entities. While legislation captures all the excitement with lobbying and either amending or passing new laws, when it comes to healthcare, the gaps legislation oftentimes leaves open-ended are left to an agency to do the details of filling in the gaps. For example, specifics on reimbursement or licensing changes are usually done by the likes of CMS, FDA, HRSA or state departments of insurance.

Changes are done via rulemaking, which are found in the federal or state register. Through proposed rules, agencies give stakeholders an opportunity to comment on a rule change, which starts a certain timed process.

Participation in agency rulemakings are key because these rules affect the finer points of your operation. Additionally, not knowing about a change in these critical rules can oftentimes result in adverse action from an agency like a fine or a warning letter if your compliance is not up to date.

Frier Levitt Government Affairs (FLGA) guides healthcare and life sciences stakeholders through the regulatory comment process. FLGA looks at your business model, monitors for proposals that will impact you, and counsels you on strategic next steps. Additionally, healthcare and life sciences stakeholders will get the benefit of working with boutique healthcare law firm Frier Levitt, LLC, who will help ensure that your company stays compliant with any news rules that are promulgated.

FLGA offers a hybrid service flexible with an organization’s changing needs. We monitor and forecast regulatory issues of importance in a concise, easy to understand and time friendly format. Our monitoring and forecasting services allow stakeholders to stay educated and engaged on new developments before the trends become mainstream.

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

FDA Seeking Comments on New Guidance Regarding Rare Diseases

The FDA has released a new draft guidance document titled, “Rare Diseases: Natural History Studies for Drug Development.” The guidance document impacts pharmacy supply chain stakeholders, especially drug manufacturers and specialty interests.

What Does the Guidance Do?

According to the FDA, the Agency is publishing this draft guidance to help inform the design and implementation of natural history studies that can be used to support the development of safe and effective drugs and biological products for rare diseases. A natural history study collects information about the natural history of a disease in the absence of an intervention, from the disease’s onset until either its resolution or the individual’s death. Although knowledge of a disease’s natural history can benefit drug development for many disorders and conditions, natural history information is usually not available or is incomplete for most rare diseases, therefore, natural history information is particularly needed for these diseases.

Why You Should Participate:

If you are supply chain stakeholder looking to diversify your business into biological products or to serve rare disease patients, the trend is pointing towards greater utilization of specialty products. Comments are suggested to ensure that the government has your viewpoint in mind when developing further guidance and proposed rules.

There are multiple ways to respond to the “Rare Diseases: Natural History Studies for Drug Development” guidance document. Contact Frier Levitt Government Affairs to have your voice heard.