FDA Archives - Green Market Report

StaffOctober 11, 2021
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4min17320

In a big “oops we goofed,”  the Food and Drug Administration (FDA)  took back its September 14 Marketing Denial Order for some of Turning Point Brands, Inc.  (NYSE: TPB) vape products. Turning Point said all of its proprietary vape products, including its Solace branded e-liquids, will continue to be marketed while they remain under review. They are currently under a pending Premarket Tobacco Product Applications (“PMTAs”) review.

Turning Point said that in its rescission letter the FDA stated, “Upon further review of the administrative record, FDA found relevant information that was not adequately assessed. Specifically, your applications did contain randomized controlled trials comparing tobacco-flavored ENDS to flavored ENDS as well as several cross-sectional surveys evaluating patterns of use, likelihood of use, and perceptions in current smokers, current ENDS users, former tobacco users, and never users, which require further review.” The letter further clarified that “at present, in light of the unusual circumstances, FDA has no intention of initiating an enforcement action against” the products.

“We are encouraged by the FDA’s decision to reconsider our product applications and look forward to engaging the agency as our PMTAs are reviewed,” said Larry Wexler, President and CEO, Turning Point Brands. “It is important that the PMTA process is transparent, purposeful, and evidence-based. Our organization dedicated significant time and resources in filing our applications in accordance with agency guidance. We remain hopeful that the depth and range of our studies and data will persuade the FDA that the continued marketing of our vapor products is appropriate for the protection of the public health and that the agency will ultimately preserve a diverse vapor market for the more than 30 million American adult smokers who may wish to transition from combustible cigarettes to lower risk alternatives.”

Turning Point had been selling vape products under the label Solace with flavors like Peach, Mango, and Marshmallow Crispy. These sugary flavors have been very popular with underage consumers and were a big selling point for the competitor Juul. Solace noted on its website that Federal law required e-liquid companies to submit a Premarket Tobacco Product Application (PMTA) to the U.S. Food and Drug Administration (FDA) in order to continue selling products in the United States. These applications require that e-liquid companies demonstrate that products are “appropriate for the protection of public health.”

Turning Point has reported spending $14 million in 2020 on the PMTA application according to the company’s annual filing. In 2019, the company spent  $2.2 million on the PMTA. Turning Point also said that as a result of the rescission letter, it withdrew both the petition for relief and motion to stay that it had filed with the 6th Circuit Court of Appeals.


StaffAugust 13, 2021
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8min10751

Charlotte’s Web (OTC: CWBHF) CEO Deanie Elsner addressed the company’s recent rejection letter by the FDA in the company’s earnings call on Thursday. Since the passage of the 2018 Farm Bill that legalized hemp, the issue of CBD products has remained in a grey area. The FDA has had several public meetings and accepted public comments on the subject, but it still hasn’t made any specific decisions.

Charlotte’s Web was specifically focused on a regulatory pathway for full spectrum hemp extract with naturally occurring CBD. CBD products remain unregulated as the industry has grown to become a $3 billion to $4 billion industry.

FDA Punts To Congress

“After 2.5 years, it has become increasingly more apparent that in the FDA’s own words, potential legislation might be appropriate to enable a framework for under which the FDA can regulate full spectrum hemp extracts as dietary supplements,” said Elsner. “During the second quarter of 2021, we put this thesis to test by formally submitting a new dietary ingredient notification to the FDA for our full spectrum hemp extract as they have been recommending. The FDA responded with an objection letter to our NDI notification. Their response substantially based on their drug preclusion provision reveals that legislation is required to enable the FDA to establish a regulatory oversight for full spectrum hemp extracts as dietary supplements. Both the House and the Senate have introduced bills that would recognize hemp CBD as a dietary supplement and we are encouraged by this progress.”

When asked about the specifics of the letter, Elsner went on to say, “I will start with we were disappointed and strongly disagreed with not just the conclusion that they advanced, but the reasoning for their conclusions, because their letter back to us contained a significant amount of factual inaccuracies. And so the first thing I would tell you to do is on our website in the IR section, we have posted our response to the FDA. And we laid out an excruciating detail why we think they need to create the record in terms of what we submitted and what they concluded.

Now, that said, they drew a conclusion based on two examples. One was, they can’t move forward with an NDI as a dietary supplement because CBD is precluded, because it’s already a drug. And as you know, six months prior to the hemp bill being signed into law in December 2018, a drug was approved that’s CBD isolate. The second reason why they objected to our NDI was that they expressed safety concerns. And I think that’s the part that we are looking for a correction on, because regarding safety, the conclusions drawn just don’t appear to be based on the data we provided in our NDI. So, that’s we are trying to get focused on. In terms of what does it mean, I think what you are getting to is, it is the industry has been caught in a little bit of a catch-22, because the FDA has not been clear about the process by which they want companies to go through to gain regulatory clarity. And Congress has been pointing to the FDA to take responsibility for this.

And so our decision was full transparency, to force the issue to see who has the next decision. And with the FDA objecting to our NDI, it becomes very clear that the regulatory process to get established has to start with Congress, legislative and the FDA to regulate the dietary supplement for CBD, and then FDA can regulate within. And so I am confident there is a way to do this. Over the last 18 months, we have met with the FDA, about eight to ten different times and our meetings were very constructive. I have got a great deal of respect for the FDA. But I think they are in a bit of a catch-22, because they have approved the drug. And they can’t seem to move away from that precedent. And so Congress has to act. And I think once Congress acts, the FDA can be very clear about the process. The process is scientific. It’s intense. There is a ton of data that we have got to do to submit for it. And I feel really good having gone through this knowing what they are looking for. But now we need Congress to act. And when that happens, I think the category will be able to submit NDIs and the whole thing will begin to open up.”

THC Challenge

Elsner was asked whether relying on Congress would be any better and she answered, “This is not just a CBD hemp industry challenge. This is a THC sector challenge, because we are going through with hemp extracts with naturally occurring CBD is exactly what the cannabis industry is going to have to do following us. And so this is not Congress, maybe or maybe not engaging on the hemp CBD industry. This is Congress looking at a category today, that is roughly $17 billion to $20 billion in total in the US across 11 states where cannabis is legal and CBD participates. And so some kind of resolution has to be landed for how both of these categories are regulated. And the FDA has to have clarity and perspective about how they want companies to produce safe products for consumers in a way that is holding manufacturers to a very high level of standard. And so we are doing this for ourselves, but doing this for our category. We are doing this in support of our consumers. But it’s the whole sector that is going to put the pressure for Congress to act and push the FDA to move forward. And we will continue to push both fronts.”


StaffMarch 22, 2021
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7min13160

The U.S. Food and Drug Administration has issued warning letters to two companies for selling products labeled as containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the warning letters address the illegal marketing of unapproved drugs labeled as containing CBD. The companies are Honest Globe and Biolyte Laboratories.

The letter sent to Honest Globe referenced the products “ELIXICURE ORIGINAL PAIN RELIEF with CBD” (roll-on and pump versions) and “ELIXICURE LAVENDER PAIN RELIEF with CBD” (roll-on and pump versions) (hereinafter referred to as “ELIXICURE PAIN RELIEF with CBD” products). The “ELIXICURE PAIN RELIEF with CBD” products were labeled as containing cannabidiol (CBD) and require no prescription.

The letter read, “Your “ELIXICURE PAIN RELIEF with CBD” products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). Furthermore, your “ELIXICURE PAIN RELIEF” products are misbranded drugs introduced or delivered for introduction into interstate commerce in violation of sections 502(a), 502(ee), and 301(a) of the FD&C Act, 21 U.S.C. 352(a), 352(ee), and 331(a).” The FDA also said that although CBD was listed as an inactive ingredient in the labels of the “ELIXICURE PAIN RELIEF with CBD” products, the product labeling clearly represented CBD as an active ingredient, which is a component of a drug intended to furnish pharmacological activity or other direct effects in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body. Ultimately an inactive ingredient should not exert pharmacological effects.

In addition to the marketing, Honest Globe was cited for production issues. The letter stated, “Your Quality Unit (QU) lacked control over your topical over-the-counter drug manufacturing operations and failed to ensure that you had adequate procedures. In your response, you committed to working with your contract laboratory to investigate the cited OOS results and future OOS results. Your response is inadequate because you did not address your responsibilities to investigate potential manufacturing deficiencies that may have led to the OOS results. Your response also failed to evaluate batches with OOS test results that had been distributed and were still within expiry.”

Honest Globe also got itself in trouble with claiming its products to be registered with the FDA . “To state that any drug product is “FDA registered” is inaccurate; drugs are subject to listing with FDA, not registration. Moreover, registration of an establishment or listing of a drug does not denote approval of the establishment, the drug, or any other drugs of the establishment, nor does it mean that a product may be legally marketed.”

Biolyte Laboratories LLC was the other company that received a letter. The company made medical claims about its products. Examples given were  “Silver Gel,” – used as an antimicrobial to help treat minor skin wounds, burns, infections . . .” “Silver Gel” – “USEFUL FOR WOUNDS, BURNS, BANDAGES, AND MORE . . . TOPICALLY USED AGAINST INFECTIONS . . . TOPICALLY USED AGAINST SEVERAL SKIN CONDITIONS (Hives, Rashes, eczema, diaper rash).”

“Based on the above labeling claims, your products “(b)(4) Therapeutic Pain Gel,” “(b)(4) Pain Relief Cream,” and “(b)(4) Magnesium Oil Spray” are drugs intended for use as external analgesics. We are not aware of any adequate and well-controlled clinical studies in the published literature that support a determination that “(b)(4) Therapeutic Pain Gel,” “(b)(4) Pain Relief Cream”, or “(b)(4) Magnesium Oil Spray” are generally recognized as safe and effective (GRASE) for use under the conditions suggested, recommended, or prescribed in their labeling.”

The FDA has not approved any over-the-counter (OTC) drugs containing CBD, and none of these products meet the requirements to be legally marketed without an approved new drug application. The letters explain that, as CBD has known pharmacological effects on humans, with demonstrated risks, it cannot be legally marketed as an inactive ingredient in OTC drug products that are not reviewed and approved by the FDA. Additionally, the letters cite substandard manufacturing practices, including failure to comply with current good manufacturing practices.

The FDA said in a statement that the products that are the subject of the warning letters issued today have not gone through the FDA drug approval process and are considered unapproved new drugs. There have been no FDA evaluation of whether these unapproved drug products are effective for the uses manufacturers to claim, what an appropriate dose might be, how they could interact with FDA-approved drugs or other products, or whether they have dangerous side effects or other safety concerns.


Debra BorchardtJuly 21, 2020
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3min12490

The FDA issued draft guidance for clinical research related to the development of drugs containing cannabis or cannabis-derived compounds. The FDA is taking comments and suggestions for the next 60 days. The guidance does not address the development of fully synthetic versions of substances that occur in cannabis.

As part of drug development, sponsors may conduct clinical trials under an investigational new drug (IND) application to determine if a drug is safe and effective for a particular intended use. The IND application provides a mechanism for those developing a new drug to conduct studies and ship their proposed drug to clinical trial sites. The data obtained from these studies may later become part of a new drug application (NDA), which is then used to formally propose that FDA approve a new drug for sale in The United States.

  • The following additional principles and recommendations are particularly relevant for
    developing drugs that contain cannabis and cannabis-derived compounds:

    Cannabis is held to the same regulatory standards as any other botanical raw material,
    botanical drug substance, or botanical drug product. The general considerations and
    recommendations for botanical drugs contained in the guidance for industry Botanical
    Drug Development (December 2016) provides core principles for conducting clinical research on botanical drugs, including drugs that contain cannabis and cannabis-derived compounds.

  • In addition, FDA recommends that those pursuing drug development using cannabis or cannabis-derived compounds consider the following principles and documents:  — Adequate characterization of cannabis and cannabis-derived compounds, for example via a chemical fingerprint, is critical to ensure batch-to-batch consistency.  — USP General Chapter <561> Articles of Botanical Origin, particularly regarding tests for residual pesticides, including any pesticides routinely used in the countries of origin of botanical raw materials.
  • There may be drug scheduling considerations under the CSA for applicants pursuing FDA approval of an NDA for a drug that contains cannabis or cannabis-derived compounds. FDA’s review of the NDA may include an abuse potential assessment to inform labeling and to provide DEA with a scientific and medical evaluation of the drug’s abuse potential.
  • The human major metabolite of cannabidiol, 7-COOH-CBD, is expressed disproportionately in humans compared to animals. While disproportionate metabolism is not limited to botanical products, FDA would like to make stakeholders aware that this is a known issue with certain cannabinoids.
  • Activities related to growing and manufacturing cannabis for use as an investigational drug for research must comply with CSA and DEA requirements

StaffApril 24, 2020
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7min17480

The U.S. Food and Drug Administration (FDA) has issued warning letters to two companies for illegally selling unapproved products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA said that BIOTA Biosciences and Natures CBD Oil Distribution were claiming their CBD products could be used to treat opioid addiction.

The FDA has requested responses from the companies within 15 working days stating how they will correct the violations. Failure to correct the violations promptly may result in legal action, including product seizure and/or injunction.

“The opioid crisis continues to be a serious problem in the United States, and we will continue to crack down on companies that attempt to benefit from selling products with unfounded treatment claims,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “CBD has not been shown to treat opioid addiction. Opioid addiction is a real problem in our country and those who are addicted need to seek out proper treatment from a health care provider. There are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD, and we will continue to work to protect the health and safety of American consumers from products that are being marketed in violation of the law.”

The two warning letters were issued to:

  • BIOTA Biosciences, LLC of Washington state for marketing and distributing injectable CBD products as well as an injectable curcumin product. These products are marketed for serious diseases and as an alternative to opioids. BIOTA Biosciences markets private label CBD and wholesale CBD extracts, and their products include beverages, bulk CBD extracts, and water soluble CBD, as well as injectable curcumin.
  • Homero Corp DBA Natures CBD Oil Distribution of New Hampshire for marketing and distributing CBD products as a treatment to opioid addiction as well as other serious diseases. The firm is an own-label distributor for CBD products as well as a retailer for Green Roads CBD products.

The FDA noted that Natures CBD website claimed that its product “Has had success in alleviating severe withdrawal symptoms associated with opiate dependency. Natures Pure CBD also has taken off the ball and chain around the opiate addicts’ neck and has relieved the addiction totally by using Natures Pure CBD restoring the person back to a quality of life worth living.”  “The Opiate addiction rate of recovery is low and Natures Pure CBD oil offers promise for those suffering from chronic opiate use.”  “Natures Pure CBD oil works for these medications which all have addictive properties to them: opium, fentanyl, heroin, hydrocodone, oxycodone, methadone, morphine and hydromorphone. Natures Pure CBD Oil has been effective in the treatment and eradication of opiate use.”

For BIOTA, the FDA pointed out claims on the website like “CBD . . . and its ability to suppress pain and aid in the detoxification processes has highlighted it as a promising therapeutic for a wide array of disorders such as epilepsy, including many challenging neuropathy conditions. When patients consider trying a new therapeutic like CBD, there are many options for delivery that can be more efficacious to the patient. One delivery option is BIOTA CBD Sterile Vial Therapy.”  “Instant relief for patients that are symptomatic of inflammatory auto-immune diseases”

While there has been anecdotal talk of cannabis with THC as a potential solution to weaning opioid addicts to a less dangerous level of drug use, it has never been proven to be a fail-safe alternative. There have been no FDA evaluation of whether these products are effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs, or whether they have dangerous side effects or other safety concerns.

In addition, the manufacturing process of unapproved CBD drug products has not been subject to FDA review as part of the human or animal drug approval processes. In March, the FDA provided updates on its work related to CBD products with a focus on protecting public health and providing market clarity. The FDA continues to be concerned that some people wrongly think that the myriad of CBD products on the market have been evaluated by the FDA and determined to be safe, or that using CBD “can’t hurt.”

Under the FD&C Act, any product intended to treat a disease or otherwise have a therapeutic or medical use, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug. The FDA has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy.


Debra BorchardtMarch 9, 2020
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4min17150

The FDA provided an update on its efforts at evaluating CBD products over the past year. The agency said that it is taking several new steps in areas of education, research and enforcement with the ultimate goal of continuing to protect the public health and working to provide market clarity.

“We’re seeing CBD being marketed in a number of different products, such as oil drops, capsules, syrups, food products, such as chocolate bars and teas, cosmetics and other topical lotions and creams, as well as products marketed for pets and other animals – and we understand consumers are seeking out these novel products for a variety of perceived health-related or other reasons,” said the FDA’s statement.

“We are concerned that some people wrongly think that the myriad of CBD products on the market have been evaluated by the FDA and determined to be safe, or that using CBD ‘can’t hurt.’ Aside from one prescription drug approved to treat two rare, severe pediatric epilepsy disorders, no other CBD products have been evaluated or approved by the FDA.”

The FDA said it was wanting to get more data on the following conditions:

  • The sedative effects of CBD
  • The impacts of long-term sustained or cumulative exposure to CBD
  • Transdermal penetration and pharmacokinetics of CBD
  • The effect of different routes of CBD administration (e.g., oral, topical, inhaled) on its safety profile
  • The safety of CBD for use in pets and food-producing animals
  • The processes by which “full spectrum” and “broad spectrum” hemp extracts are derived, what the content of such extracts is, and how these products may compare to CBD isolate products

Reopening Public Comments

The FDA said it was re-opening the public docket that was created for the May 2019 public hearing. “We have decided to extend the comment period indefinitely to allow the public to comment and to share relevant data with the agency. This docket also includes a mechanism for a stakeholder to submit data or information that the stakeholder believes to be confidential.”

The FDA’s Office of the Chief Scientist was also recently awarded a grant to the FDA’s National Center for Toxicological Research to conduct a study to better understand the effects of CBD exposure during pregnancy. “Additionally, we’ve initiated a research study in partnership with the University of Mississippi to evaluate the levels of CBD and THC in a sample of cosmetic products to assess sensitization of THC and CBD topically, and dermal penetration.”

No New Guidance on Products

While the FDA did decide to reopen the docket and has begun to dip its toes into research, the agency gave very little new guidance with regard to products. It only stated, “We also have serious concerns about products that put the public at risk in other ways. For example, we are aware of the risks posed by product contaminants such as heavy metals, THC or other potentially harmful substances. We also have significant concerns about products marketed with false claims or statements such as omitted ingredients, incorrect statements about the amount of CBD, products marketed for use by vulnerable populations like children or infants, and products that otherwise put the public health at risk.”

The agency merely stated It was evaluating the issuance of a risk-based enforcement policy.


Julie AitchesonFebruary 21, 2020
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5min20390

Editor’s Note: This story was originally published on our sister site Hemp Market Report.

Amidst concerns on the federal and state levels about violations of FDA regulations regarding CBD products, efforts are being made to allocate more money in the upcoming fiscal year to further define and more stringently enforce CBD laws. President Trump’s proposed budget for the fiscal year 2021, should he gain re-election and have the opportunity to present it to Congress, allocates an additional $5 million to the Food and Drug Administration specifically for further regulation and law enforcement pertaining to cannabis and cannabis-derived products. This is the first time that CBD has been mentioned in a federal budget proposal, which suggests that hemp and CBD may be buzzwords cropping up in Presidential debate topics alongside marijuana leading up to the election.

So where would it leave the future of CBD regulation if Trump is ousted from the White House? Democratic Presidential frontrunners Bernie Sanders and Elizabeth Warren both support the legalization of cannabis, with Sanders proposing to legalize within 100 days of his election to office. A historically outspoken proponent of the war on drugs, Joe Biden is sticking to a half-measure platform with a focus on decriminalization, allowing states to regulate hemp for themselves. Michael Bloomberg supports putting legalization in the hands of individual states, though he is personally opposed to legalization. Pete Buttigieg takes the side of veterans with PTSD who often use cannabis and its derivatives to deal with the aftermath of military service, advocating for the decriminalization of all controlled substances. 

As hemp has yet to be a talking point for presidential candidates, overshadowed as it is by the larger topic of marijuana as a flashpoint for racial justice issues (as criminalization disproportionately affects people of color), what Americans can expect from future budgetary support should a Democrat win office is unclear. What is clear is that the time for comprehensive, consistent regulations and enforcement of cannabis laws on the part of the FDA is long overdue.

  During his January 2020 testimony before the Subcommittee on Health, Committee on Energy and Commerce, and the U.S. House of Representatives, Douglas C. Throckmorton, Deputy Director for Regulatory Programs at the FDA, highlighted the current illegality (per the Food, Drug, & Cosmetic Act)  of interstate commerce of food with CBD additives. He also described in some detail concerns with current CBD marketing tactics that put consumers at risk, such as those products that claim to treat cancer or Alzheimer’s. Throckmorton also identified some particular concerns related to the potential negative health impacts of CBD use, such as liver damage, problematic drug interactions, male reproductive toxicity, and various ill side effects. 

While studies of these impacts are still ongoing and inconclusive, the FDA is clearly intent on taking them, and the future of CBD in the U.S. market, seriously. Whether the President-elect of the United States, whoever he or she may be, manages to pass a budget that supports the FDA in its mission to ensure public safety in regards to CBD is, in many respects, for voters to decide.


StaffNovember 25, 2019
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10min27680

On Monday, the U.S. Food and Drug Administration has issued warning letters to 15 companies for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA also published a revised Consumer Update detailing safety concerns about CBD products more broadly. The FDA also indicated in the press release that it cannot conclude that CBD is generally recognized as safe among qualified experts for its use in human or animal food.

The warning letters sent to these companies were accused of using product webpages, online stores and social media to market CBD products in ways that violate the FD&C Act, including marketing CBD products to treat diseases or for other therapeutic uses for humans and/or animals. The FDA also noted that some of the products were marketed towards infants and children, which could have adverse reactions. Other violations include marketing CBD products as dietary supplements and adding CBD to human and animal foods.

“As we work quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD, we’ll continue to monitor the marketplace and take action as needed against companies that violate the law in ways that raise a variety of public health concerns. In line with our mission to protect the public, foster innovation, and promote consumer confidence, this overarching approach regarding CBD is the same as the FDA would take for any other substance that we regulate,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD ‘can’t hurt.’ Aside from one prescription drug approved to treat two pediatric epilepsy disorders, these products have not been approved by the FDA and we want to be clear that a number of questions remain regarding CBD’s safety – including reports of products containing contaminants, such as pesticides and heavy metals – and there are real risks that need to be considered. We recognize the significant public interest in CBD and we must work together with stakeholders and industry to fill in the knowledge gaps about the science, safety and quality of many of these products.”

The companies receiving warning letters are:

Under the FD&C Act, any product intended to treat a disease or otherwise have a therapeutic or medical use, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug. The FDA has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy.

The FDA also does not approve of companies selling CBD products with the suggestion that the product should be added to either human or animal food.


Debra BorchardtOctober 22, 2019
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4min20270
The U.S. Food and Drug Administration and the Federal Trade Commission posted a joint warning letter dated October 10, 2019 to Rooted Apothecary LLC, of Naples, Florida, for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat teething pain and earaches in infants, autism, attention-deficit/hyperactivity disorder (ADHD), as well as Parkinson’s and Alzheimer’s disease, among other conditions or diseases.
The company used product webpages to make unfounded medical claims about its CBD products, and some of the products were also unlawfully marketed as dietary supplements. The agency has determined that CBD products cannot be marketed as dietary supplements.
The letter read, “The FDA has determined that your “Teeth/TMJ – Essential Oil + CBD Infusion,” “Ears – Essential Oil + CBD Infusion,” “Hemp Capsules, 750 mg,” “Hemp Infused Body Butter,” and “Hemp Oil” products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, these products are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). “
The letter noted that “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended. “Your products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes.”
It went on to say “It is unlawful under the FTC Act, 15 U.S.C. § 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made.” The letter cited the product POM Wonderful, a pomegranate beverage that is suggested to be healthy.
The company has 15 days to correct its violations.

Debra BorchardtSeptember 17, 2019
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4min12870
According to the U.S. Hemp Roundtable,  Majority Leader Mitch McConnell (R-KY) introduced language on the Agriculture Appropriations bill that would require the FDA to issue formal “enforcement discretion” on the sale of hemp CBD products.  The FDA had suggested it would take them 3-5 years to decide on rules and regulations for CBD.

The group’s website posted that the US Senate Appropriations Subcommittee on Agriculture will “mark up” language submitted by Senator McConnell that would require the FDA to formally stand down on any enforcement of its troublesome anti-CBD guidance. The notes are as follows:

  • Within 90 days, provide Congress a report outlining its efforts to develop an enforcement discretion policy on hemp CBD;

  • Within 120 days, issue its formal enforcement discretion policy on hemp CBD;

  • Keep the enforcement discretion policy in effect until the agency has implemented its final regulatory process; and

  • Ensure that going forward, CBD manufacturers would be able share safety data through existing FDA notification procedures to be fully compliant with federal law and policy.

The group also added that the bill will be marked up by the full Senate Appropriations Committee on Thursday, and could go to the full Senate soon. The Hemp Roundtable said that last week, Reps. Chellie Pingree (D-ME) and James Comer (R-KY) sent all members of the US House of Representatives a “Dear Colleague” letter, asking them to co-sign a letter that urges the FDA to issue formal “enforcement discretion” on the sale of hemp CBD products.

One of the biggest complaints following the passage of the 2018 Farm Bill that legalized hemp was that the product remained in a legal quagmire. Some states have outlawed hemp-derived CBD products, while others have no problems. Banks aren’t sure how to address CBD customers and even e-commerce has struggled with the issue. Shopify only just announced on Tuesday that it began working with CBD merchants, while Google refuses to allow CBD advertising.

The letter said, “However, FDA’s current regulatory approach on CBD has created significant regulatory
and legal uncertainty for participants in this quickly evolving industry. FDA maintains that food products
containing CBD remain illegal under the FDCA because it is the active ingredient in an epilepsy drug,
Epidiolex, that is undergoing clinical trials. Although the agency is exploring alternative regulatory
pathways, the FDA claims that a rulemaking process could take the agency anywhere between 3-5 years
to complete.”

 

 


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