Tag Archives: unsubstantiated

Bad Actors in CBD: How to Distinguish Quality Products From the Rest

By Joseph Dowling
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The success of reputable cannabis and CBD brands has inspired an influx of inexperienced and disreputable competitors in the market. These so-called “bad actors” in CBD advertise products that are not manufactured under current Good Manufacturing Practices (cGMP), which help to ensure that all products are consistently produced and controlled according to specified quality standards. cGMP helps guard against risks of adulteration, cross-contamination and mislabeling to guarantee product quality, safety and efficacy.

Joseph Dowling, Author & CEO of CV Sciences

CBD products without cGMP regulations are often inaccurately labeled and deceiving to consumers. In fact, in a test of over 100 CBD products available online and at retail locations, Johns Hopkins Medicine found significant evidence of inaccurate, misleading labeling of CBD content. The prevalence of such brands not only reduces consumer confidence in CBD but also limits the growth of the sector as a whole. Fortunately, CBD consumers and retailers can easily discriminate between a well-tested, reputable brand and inferior bad actors with a few straightforward, minimum requirements to look out for when selecting a product.

Why are “bad actors” a problem for consumers and the industry?

Bad actors in CBD sell products that are not produced under cGMP conditions and are typically not tested by third-party laboratories to ensure identity, purity, quality, strength and composition. This means they are not verified for contaminants, impurities, label claims and product specifications. This frequently results in misleading advertising with inaccurate levels of cannabinoids or traces of compounds not found on the label, like THC. To combat this, the FDA issues warning letters to actors that market products allegedly containing CBD—many of which are found not to contain the claimed levels of CBD and are not approved for the treatment of any medical condition. Still, bad actors manage to slip through the cracks and deceive consumers.

The structure of cannabidiol (CBD), one of 400 active compounds found in cannabis.

Bad actors that put anything in a bottle and make unsubstantiated medical claims hurt the reputable operators that strive to create safe and high-quality products. It is easy for consumers to be drawn to CBD products with big medical claims and lower prices, only to be disappointed when the product does not produce the advertised results. Inaccurately labeled products may contain unexpected levels of cannabinoids, including ingredients that consumers may not intend to ingest, like Delta-9 or Delta-8 THC. Along with unexpected levels of THC, many CBD products available now are not as pure as advertised, with one in four products going untested for contaminants like microbial content, pesticides, or heavy metals.

Further, inaccurate labeling of products and their compounds also prevents consumers from establishing a baseline impact of CBD on their bodies, leaving them vulnerable to inconsistent future experiences. Such a poor experience can turn consumers off to the category as a whole, drawing their trust away from not only the bad actors but also the reliable, reputable brands on the market. The saturation of the market with these disreputable brands delegitimizes a category that has only just begun to break down the stigmas, creating stagnation rather than growth as consumers remain wary of low-quality products.

How can consumers identify bad actors in CBD?

There are several simple ways to identify a bad actor among CBD products and make certain that both consumers and retailers purchase quality, reliable and safe brands in legitimate sales channels. To start, consumers should avoid all CBD products that are marketed with unsubstantiated medical claims. This is a significant area of abuse, as brands that relate any form of CBD product to a disease state, like cancer, should not be trusted. The science to support such medical claims has not been completed, yet, product marketing is years ahead of the evidence to support such claims. Unsupported medical claims could also mislead consumers that may need more serious medical intervention.

Just some of the many CBD products on the market today.

Additionally, consumers must review the packaging, which should include nutrition information in the form of a supplement fact label. The label should include the serving size, number of servings per container, a list of all dietary ingredients in the product and the amount per serving of each ingredient. All labels should include a net quantity of contents, lot number or batch ID, the name and address of the manufacturer, and an expiration or manufacturing date. These signs of a reputable brand are easy to look for and can save consumers from the trouble of selecting the wrong CBD product.

What to look for when selecting a CBD product

With this in mind, products from reputable, tested brands can be identified by a few key factors. Reputable CBD companies are already compliant with the FDA regulations on nutritional supplements, including a nutritional or supplement fact panel on the packaging—just like vitamins. The information in this panel should include all the active cannabinoids in the product, both per serving and package. Clear potency labeling allows consumers to confidently select products that suit their needs and understand the baseline impact of CBD concentration on their bodies, thus helping them to tailor their experience with thoughtful product selection.

Reputable brands also include a convenient QR code on the packaging, linking the product to a certificate of analysis that details the testing results to demonstrate compliance with product standards and label claims. In terms of specific ingredients, consumers should be skeptical of high concentration levels of “flavor of the month” minor cannabinoids, which are often associated with unsubstantiated medical claims. Current scientific research has set its focus on major cannabinoids like CBD and Delta-9 THC, leaving additional research necessary for understanding minor cannabinoids. Minor cannabinoids are typically included in full spectrum products at concentrations found naturally in the cannabis plant, which is a safer approach to consuming CBD until more research is completed.

Consumers should not let the existence of unreliable, untrustworthy brands curtail their confidence in the CBD sector—there are many high-quality, safe and trusted brands on the market. With a knowledgeable and discerning eye, consumers and retailers can easily select top-quality CBD products that millions of consumers have found to improve many aspects of their health and well-being. Looking ahead, clear federal regulations for CBD products that require mandatory product registration, compliance with product labeling, packaging and cGMP will be crucial in weeding out bad actors and will allow compliant companies to gain consumer trust and responsibly grow the CBD category.

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FDA Warning Letters: Stop Claiming CBD Prevents COVID

By Cannabis Industry Journal Staff
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Once again, the U.S. Food and Drug Administration (FDA) has issued a number of warning letters to companies selling hemp-derived cannabidiol (CBD) products. This time around, the FDA sent these warning letters to companies that had statements on their website claiming CBD is an effective treatment or prevention of Covid-19.

In this latest round, the FDA sent a total of seven warning letters to:

Just some of the many hemp-derived CBD products on the market today
  • Greenway Herbal Products LLC
  • UPSY LLC
  • Functional Remedies, LLC dba Synchronicity Hemp Oil
  • Nature’s Highway
  • Heaven’s Organic LLC
  • Cureganics
  • CBD Social

Earlier this year, a slew of preliminary research studies went viral for shedding light on promising signs that certain cannabis compounds could help treat or prevent Covid-19. The conclusions from most of that research is: It is still too early to tell if any of these studies will show evidence of cannabis treating Covid-19, let alone if they mean cannabis products can be used as a treatment or preventative for Covid-19. However, the research is significant and we should keep an eye on any developments that come from those studies.

The hemp-derived CBD market has a history of clashes with the FDA over health claims. Since the Farm Bill legalized cannabis with less than 0.3% THC back in 2018, the hemp-derived CBD market has proliferated, with all sorts of companies seizing the opportunity. Jumping on the health and wellness trend, companies incorporated this messaging into their marketing campaigns. Over the past four years, the FDA has issued dozens and dozens of warning letters and threatened enforcement actions to companies making unsubstantiated health claims about CBD.

While CBD definitely does have medical benefits, such as being used as an anti-inflammatory or anticonvulsant, preliminary research alone is not enough to say it does. Products need to be approved by the FDA with a new drug application (NDA) in order to make those claims. Therefore when companies make unsubstantiated health claims about their CBD products, like claiming it can prevent Covid-19, they are violating the FD&C Act by marketing “unapproved new drugs” or “misbranded drugs.”

The bottom line is companies that are marketing CBD products need to ensure that their marketing materials and labeling comply with FDA requirements and avoid making unapproved drug claims.

FDA Says No, CBD Does Not Cure COVID-19

By Aaron G. Biros
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Former NFL player Kyle Turley made headlines this week for some eye-catching remarks. The retired offensive lineman entered the cannabis industry in 2017, when he launched Neuro Armour (now called Neuro XPF), a brand of CBD products.

Turley and his Neuro XPF brand made claims in recent weeks, both on their website and in various social media posts on Facebook and Twitter, saying that their CBD products can cure COVID-19. Two quotes below, one from their website and one from a Facebook post, show how the company touted CBD as an effective medicine for treating COVID-19.

  • “Crush Corona . . . While scientists around the world are working 24/7 to develop a COVID-19 vaccine, it will take many more months of testing before it’s approved and available. However, there’s something you can do right now to strengthen your immune system. Take CBD . . . CBD can help keep your immune system at the stop of its game. . . . We want everyone to take CBD and take advantage of its potential to help prepare your body to fight a coronavirus infection. So, we’re making all of our products more affordable.”

  • “Crush Corona! Your best defense against the COVID-19 blitz starts with a strong immune system. It’s what protects your body from the everyday attacks of bacteria, viruses, parasites and a host of other nasties. Learn more here: https://neuroxpf.com/crush-corona/” FDAlogo

The U.S. Food & Drug Administration (FDA) got wind of these marketing tactics and sent Turley and his brand a warning letter. “FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people,” reads the warning letter. “As described below, you sell products that are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. We request that you take immediate action to cease the sale of such unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.”

Before entering the cannabis space, Turley was diagnosed with chronic traumatic encephalopathy (CTE) and then early onset Alzheimer’s as a result of sustaining head injuries while playing in the NFL. Turley has a reputation for being an outspoken cannabis activist, crediting cannabis with improving his quality of life and eliminating the need for prescription opiates.

In a tongue-and-cheek response to the FDA, Turley posted the following on twitter: “OK OK, YOURE ALL RIGHT, ILL ADMIT IT! CHEAP CBD BRAND PRODUCTS WILL NOT PREVENT OR CURE COVID19!” Turley, making light of the situation, inserted the term “cheap” in there, almost challenging the FDA and disregarding their warning letter.

However, the FDA is not joking when they send these warning letters. According to the letter, Turley and his company have 48 hours to remediate the situation or face a federal court injunction.

Consumer Protection Laws & CBD Products—What You Need to Know Before Going to Market

By Jonathan C. Sandler, Alissa Gardenswartz
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By now, cannabis companies have heard that the Food and Drug Administration (FDA) has issued a slew of warning letters to sellers of CBD products for selling unapproved and mislabeled drugs and illegally adulterated food, as prohibited by the Federal Food, Drug and Cosmetic Act. However, companies marketing CBD products should know that making any health-related claims about their products also exposes them to liability under state and federal consumer protection laws. These laws additionally prevent CBD sellers from misrepresenting how much CBD is contained in their products, and even govern how companies communicate with their customers via text message. As the former head of consumer protection enforcement in Colorado and a lawyer routinely defending consumer protection class actions in California, we have seen firsthand how not considering these laws when developing a sales and marketing strategy can result in protracted and expensive litigation.

Consumer Protection Laws – Federal and State

Section 5 of the Federal Trade Commission (FTC) Act provides that “unfair or deceptive acts or practices in or affecting commerce . . . are declared unlawful.”1 The FTC enforces this law, and has clarified that “deceptive” practices involve a material representation, omission or practice that is likely to mislead a reasonable consumer under the circumstances.2 In other words, a claim is deceptive if an average consumer would believe and rely on the misleading claim to buy something. With the rise of social media marketing, the FTC has also issued disclosure guidelines for companies and influencers promoting products online.3 Every state has some form of consumer protection statute that similarly prevents deceptive marketing, and is typically enforced by the state’s attorney general. Many state laws also allow for consumers to bring actions themselves.

Both the FTC and state attorneys general have used these laws for decades against companies making scientifically unsupported health claims about their products. Just this month, the FTC and the Maine attorney general filed a lawsuit against two dietary supplement companies who were claiming that their products were a “miraculous natural solution” for life-threatening diseases. According to the lawsuit, the companies violated a 2018 settlement that required them to not make any health claims about their products without first conducting at least one randomized, double-blind, placebo-controlled trial to support the claims.4 While much of the enforcement around dietary supplements has focused on unsubstantiated health claims, other actions have been brought for improper “expert” endorsements as well as misrepresenting the amount of active ingredient contained in the supplement.5 In other words, these laws are used to police all manner of labelling and marketing of products, including those containing CBD. The FTC has already issued warning letters to CBD companies several times this year, and has stated that CBD sellers could be subject to enforcement for making unsubstantiated health claims.6

While consumer protection laws are largely focused on the content of advertisements, there are also laws that address how sellers can communicate with consumers. The Telephone Consumer Protection Act (TCPA) restricts telemarketing and the use of automated systems to contact consumers, and applies to both voice calls and text messaging. Both the FTC and state attorneys general can enforce the TCPA, and consumers can bring private TCPA actions as well. Because the TCPA allows for courts to award $500 per violation—that is, per illegal call or text—companies can face judgments into the millions of dollars.

Recent Consumer Protection Lawsuits in the Cannabis Industry

Cannabis is proving to be an attractive target for consumer protection litigation.All companies need to navigate consumer protection laws when they market their products, but class action lawyers may be pursuing cannabis companies in particular because of the products’ legal uncertainty, and because they provide opportunities for unique claims of deception. For example, a nationwide class of consumers recently filed a lawsuit in California against a CBD company that had received a warning letter from the FDA in November of this year, alleging that they would not have purchased the company’s CBD products if they knew selling the items was illegal.7 The consumers claimed violations of a variety of California and Arizona consumer protection laws, including those related to breach of warranty and unfair competition. Other lawsuits have been brought because products did not contain the amount of CBD as represented on the label, or because the product claimed to not contain THC when it did.8

Cannabis companies have been subject to TCPA class actions as well. Florida’s largest medical marijuana company has been accused of spamming customers with unwanted texts in violation of the TCPA.9 A dispensary with multiple locations in Colorado was also the subject of a TCPA class action complaint in Florida alleging that it did not obtain prior consent from consumers prior to texting them.10

Cannabis is proving to be an attractive target for consumer protection litigation. However, companies can head off lawsuits by thoroughly vetting their marketing strategies with experienced consumer protection lawyers before going to market.

References

 

  1.  15 U.S.C. Sec. 45(a)(1).
  2. See FTC Policy Statement on Deception, October 14, 1983.
  3. See Disclosures 101 for Social Media Influencers at https://www.ftc.gov/tips-advice/business-center/guidance/disclosures-101-social-media-influencers.
  4. See https://www.ftc.gov/news-events/press-releases/2019/12/ftc-state-maine-file-contempt-action-against-dietary-supplement.
  5. See FTC v. Nobetes Corp., Case No. 2:18-cv-10068 (C. D. Cal) (complaint against supplement company for using deceptive endorsements); “New York Attorney General Targets Mislabeled Herbal Supplements,” https://www.npr.org/2015/02/03/383578263/new-york-attorney-general-targets-mislabeled-herbal-supplements. (detailing the New York attorney general’s investigation of herbal supplements, and finding that they did not contain the ingredients as advertised).
  6. See https://www.ftc.gov/news-events/blogs/business-blog/2019/09/making-cbd-health-claims-careful-disseminating.
  7. Fausett et al. v. KOI CBD, LLC., Case No. 2:19-cv-10318 (C. D. Cal).
  8. Potter et al v. PotNetwork Holdings, Inc., Diamond CBD, Inc., and First Capital Venture Co., Case No. 19-cv-24017, (S. D. FL); Horn v. Medical Marijuana, Inc., Case No. 15-cv-701-FPG, (W.D.N.Y.).
  9. Jaslow v. Trulieve, Inc., Case No. 4:19-cv-RH-CAS (N.D. Fla.).
  10. Stinnett v. Hobby Farms, LLC d/b/a A Cut Above, Case No. 9:18-cv-81449-RLR (S.D. Fla.)
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FDA Issues Warnings to 15 CBD Companies, Updates Safety Concerns

By Aaron G. Biros
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On November 25th, the U.S. Food and Drug Administration (FDA) sent out warning letters to 15 different companies for “illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act).” They also published a “Consumer Update” where they express concern regarding the general safety of CBD products. The press release also states that at this time the FDA cannot say that the CBD is generally recognized as safe (GRAS). To see the list of companies that received warning letters, check out the press release here.

The structure of cannabidiol (CBD), one of 400 active compounds found in cannabis.

While the FDA is still trying to figure out how to regulate hemp and hemp-derived CBD products, they published these releases to let the public know they are working on it, according to FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D.:

“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. 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 Warning Letters

The warning letters sent to those 15 companies all mention a few types of violations to the FD&C Act. Those include marketing unapproved human and animal drugs, selling CBD products as dietary supplements and adding CBD as an ingredient to human and animal foods. All 15 companies are using websites, online retailers and social media in interstate commerce to market CBD products unlawfully, according to the press release.

FDAThis is not the first time the FDA has sent out warning letters to CBD companies. Previously, most of the warning letters were sent out regarding companies making unsubstantiated drug and health claims. This new round of 15 warning letters reaches beyond just unsubstantiated claims and identifies a few new areas of regulatory oversight that CBD companies should be wary of.

Of the 15 warning letters sent out, some were sent to companies that are marketing CBD products to children and infants, some were sent to companies using CBD as an ingredient in food products, some were marketed as dietary supplements and one company marketed their products for use in food-producing animals, such as chickens and cows. With this press release, the FDA is saying loud and clear that the above list of marketing strategies are currently unlawful, that is, until they finish their work in devising a regulatory framework for hemp-derived CBD products.

Updated Safety Concerns

Regarding the FDA saying they cannot deem CBD as generally recognized as safe (GRAS), they published a fact sheet titled “What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD.” The key words there should be noted in the parentheses: And What We’re Working to Find Out. The FDA’s research is by no means over with and, if anything, has only just begun. Refer to the fact sheet to see why the FDA couldn’t say that CBD is GRAS.

Epidiolex-GWIn the FDA’s research, they have found a few potential health problems associated with taking CBD. During the marketing application for Epidiolex as a new drug, the only approved CBD drug on the market, the FDA identified a couple of safety risks. The first one is liver injury, which they identified in blood tests, but mentioned that it could be managed easily with medical supervision. Without medical supervision, potential liver injury due to CBD consumption could go undetected, according to the FDA.

The second health concern is drug interaction. During the new drug approval process for Epidiolex, they found that other medicines could impact the dose of CBD and vice versa. The other major health concern they have is male reproductive toxicity. The FDA says that studies in lab animals showed male reproductive toxicity, including things like decrease in testicular size, inhibition of sperm growth and development and decreased circulating testosterone. They do mention, however, that “it is not yet clear what these findings mean for human patients and the impact it could have on men (or the male children of pregnant women) who take CBD.” The fact sheet also some side effects that CBD use could produce including sleepiness, gastrointestinal distress and changes in mood.

What Now?

The FDA says they are actively researching and working on learning more about the safety of CBD products. They listed a couple risks that they are looking into right now: Those include, cumulative exposure (What if you use CBD products daily for a week or a month?), special populations (effects of CBD on the elderly, pregnant or nursing women, children, etc.) and CBD in animals (safety of CBD use in pets or food-producing animals and the resulting safety of human food products like milk or eggs).

While the CBD products market could still be classified as a bit of a gray market currently, the FDA says they are working on researching it more to develop an appropriate regulatory framework. What that might look like is anyone’s guess. One thing that remains clear, however, is that the FDA will not tolerate CBD companies marketing products in ways described above. Those include making unsubstantiated health claims, marketing to children, using CBD as an ingredient in foods and marketing it as a dietary supplement.

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FDA Issues Warning To CBD Companies

By Aaron G. Biros
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On November 1st, the U.S. Food and Drug Administration (FDA) published a press release addressing warning letters issued to four companies. The warning letters, sent to companies marketing cannabidiol (CBD) products with therapeutic claims, cites unsubstantiated claims about their products’ ability to treat or cure cancer and other diseases.

A snippet of the warning letter issued to Greenroads

According to the press release, the four companies that received warning letters are Greenroads Health, Natural Alchemist, That’s Natural! Marketing and Consulting, and Stanley Brothers Social Enterprises LLC. The press release called their marketing campaigns “deceptive” for “unproven treatments.” Here is the letter they sent to Greenroads Health.

“As part of the U.S. Food and Drug Administration’s ongoing efforts to protect consumers from health fraud, the agency today issued warning letters to four companies illegally selling products online that claim to prevent, diagnose, treat, or cure cancer without evidence to support these outcomes,” reads the FDA statement. “Selling these unapproved products with unsubstantiated therapeutic claims is not only a violation of the Federal Food, Drug and Cosmetic Act, but also can put patients at risk as these products have not been proven to be safe or effective.”

According to the press release, the FDA has issued ninety warning letters in the past ten years, with around twelve this year, to companies making fraudulent claims about cancer therapies. Here are some examples of claims made by companies that the FDA took issue with:

  • “Combats tumor and cancer cells;”
  • “CBD makes cancer cells commit ‘suicide’ without killing other cells;”
  • “CBD … [has] anti-proliferative properties that inhibit cell division and growth in certain types of cancer, not allowing the tumor to grow;” and
  • “Non-psychoactive cannabinoids like CBD (cannabidiol) may be effective in treating tumors from cancer – including breast cancer.”

“Substances that contain components of marijuana will be treated like any other products that make unproven claims to shrink cancer tumors,” says FDA Commissioner Scott Gottlieb, M.D. “We don’t let companies market products that deliberately prey on sick people with baseless claims that their substance can shrink or cure cancer and we’re not going to look the other way on enforcing these principles when it comes to marijuana-containing products. There are a growing number of effective therapies for many cancers. When people are allowed to illegally market agents that deliver no established benefit they may steer patients away from products that have proven, anti-tumor effects that could extend lives.”