The FDA warning letters accuse seven CBD companies of falsely claiming that their products can treat or prevent coronavirus infections in a new joint warning letter. The letters, issued by the FTC and the FDA, were sent to several companies, including: “The FTC is deeply concerned that the claims you are making and have made through social media and your websites could represent unfair or deceptive acts or practices in violation of federal law,” the FTC wrote to Nature’s Highway and dozens of similar companies.
“The FTC advises you to take immediate action to correct these violations.” The letters also threaten regulatory action, including seizure of inventory if the companies do not stop with the unlawful claims immediately. FDA sent the letters to the following companies: Nature’s Highway, CBD American Shaman, CBD Living Water, CBD Oil Solutions, CBD Pure Life, CBDfx Hemp Oil, Healthy Hemp Oil, and My Daily Choice (MDC)
According to the FTC, the companies were told to correct their online and social media marketing immediately and ensure that their statements are truthful, non-misleading, and do not exaggerate the efficacy or promise of treating or preventing the infections. The CBD market is a Wild West of unregulated claims and product-marketing hype.
There are few enforcement actions, and the industry is not subject to most consumer protection laws. But the threat of action is raising the bar for the entire industry. The FDA and the FTC are paying more attention to CBD – and other companies are taking notice.
The companies are being told to remove the offending claims from their websites and social media platforms and submit compliance statements to the FTC and the FDA by September 7, 2018. If the companies fail to comply, the FTC and FDA could file a complaint against them in Federal Court. FTC and FDA
The FTC, the Government Accountability Office, and the National Academy of Sciences are all warning the food industry that it needs to prevent contamination of food by microorganisms better. The FDA’s website finds no approved drugs or supplements containing CBD. Suppose a company is marketing its product as a dietary supplement or food. In that case, the FDA is responsible for determining if the product is safe and lawful. The letters were sent to the following companies and individuals:
Joint warning letters were issued by the Federal Trade Commission (FTC) to these businesses:
Nature’s Highway, Inc.,
Mountain High Naturals, LLC,
Real Hemp CBD Oil™,
Organic Hemp Oil™,
Heaven’s Organics LLC
Functional Remedies LLC
Greenway Herbal Products LLC
Nature’s Highway is accused of sharing an online graphic titled “CBD + COVID-19 = BREATHE EASIER?” and writing, “several recent studies suggest that CBD, with other phytochemicals found in hemp, might open up your lungs, help fight inflammation there, and kick your immune system into a higher gear.”
“The FDA has not approved or authorized any drug containing CBD for the treatment or prevention of COVID-19. We request that you take immediate action to cease the sale of any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19,” the FDA wrote.
Additionally, the FTC issued a “cease and desist demand” within the letter, writing that “it is unlawful … to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence.” The same FTC demand was included in each of the letters.
In an interview with Cannabis Now, Nature’s Highway CEO Alan Gordon said the letter, or “frivolous complaint” as he calls it, came as a “complete surprise” as the company wasn’t attempting to make “medical claims” or “marketing claims” but was instead sharing the results of a study with its customers.
The Endocannabinoid System
The body’s endocannabinoid system regulates a wide range of biological functions. These functions include immunity, inflammation, relaxation, mood, sleep, appetite, etc. Nature’s Highway immediately complied with the FDA’s demand and removed the article. However, the company questioned the authority of the FDA to regulate the labeling and marketing of hemp products.
“We’re not even sure that the [CBD] is legal in Texas,” Nature’s Highway CEO Greg Campbell told the Temple Daily Telegram. “So we’re not sure where the FDA has authority to do this.
The FDA and FTC letters also state that the hemp oil companies need to “immediately cease” online marketing and advertising, re-educate employees, and provide additional training to supervisors regarding the effects of unapproved products containing CBD.”The law clearly requires that products marketed as ‘dietary supplements’ be safe,” said the FDA’s Dr. Matthew Bass.
On the Defensive
In response to the FDA’s letter, Nature’s Way stated that it stands behind the accuracy of its labeling and that “consumers are encouraged to read and follow the label directions.
What Does The Research Say?
The FDA warnings come amid a growing body of studies analyzing how certain cannabis compounds may work against the virus. One such study was released in January, suggesting a high purity dose of CBD could block a COVID-19 infection.
According to the report, “Cannabinoids Block Cellular Entry of SARS-CoV-2 and the Emerging Variants,” published in the Journal of Natural Products posited that certain cannabinoid acids from hemp (Cannabis sativa) can prevent infections from the virus that causes COVID-19 by obstructing its entry into cells.
CBD Social cited the study on their website to “misleadingly represent” their products containing the compound were “safe and/or effective for the treatment or prevention of COVID-19,” according to the FDA’s warning letter sent to the company on March 28.
Smoking anything, however, including marijuana or CBD, is a risk factor for COVID-19 since it affects the lungs, WebMD explains.”Smoking and drug use can lead to lung damage and lung infections,” says Steven H. Wong, MD, a pulmonologist at UCLA Health, in an email. “Inhalation of smoke and particulates can lead to bacterial and fungal lung infections. Therefore, the use of marijuana and smoking, in general, should be avoided, even in states where it’s legal. “Doctors have linked marijuana smoking to lung cancer, chronic bronchitis, and other conditions.”
It’s also unclear how the FDA plans to crack down on cannabis products sold in the U.S. without facing a potential legal battle with states that have voted to legalize marijuana for medicinal and recreational purposes. According to the National Institute of Health (NIH), “smoke from any burning substance, including marijuana smoke, contains many chemicals that can irritate the lungs.”
Cannabis can also affect the brain, mainly if used at a young age, which advices against smoking the plant. Especially in adolescents, since it can lead to a “downward spiral of adverse effects on thinking, memory, and behavior. “I don’t think any of these products will be effective [against COVID-19],” Dr. Christian Farro told WebMD. Farro is a critical care neurologist at the Mayo Clinic in Rochester, Minnesota.
“But I think any of them could be harmful,” Farro says. “If you have decreased airway resistance and oxygen levels, you could have a problem.”Most people infected with the virus don’t even know they have it. They have a very mild illness and recover completely,” WebMD writes. “Although the virus can be deadly, treatment with antiviral drugs can significantly reduce the risk of dying from the infection.
Cease And Desist Demand
At the end of their letter, the FTC issued a “cease and desist demand,” stressing that “it is unlawful … to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence.”https://hempmedicalbenefits.com/federal-legalization-of-marijuana/The FDA is calling for the companies to revise their websites and product labels “to ensure” they’re not falsely representing them as “safe and effective for a COVID-19-related use.”
J & J Snappin’ Back!
J & J Snappin’ Back! Denies that it violated any laws and said in a statement Monday that it plans to fight the FTC’s “unwarranted and unsubstantiated” allegations. Linda Suydam, president of the Natural Solutions Foundation, a nonprofit group that supports the supplements industry, told The Wall Street Journal that the action was “a matter of opinion and a matter of interpretation.”
“They decide about the status of the literature and draw a conclusion,” she stated. “There are people who believe that the literature is supportive [of the health claims]. The FTC is warning that it may take “further legal action” if the companies don’t comply. Covidien is not facing legal action, but a spokesperson for the company said it is still evaluating the letters and “will respond directly to the agencies’ concerns.
The Federal Trade Commission (FTC) enforces various consumer protection laws that include false advertising, unfair business practices, and identity theft. Since many of these companies are using deceptive advertising to sell their products, the FTC will undoubtedly be involved in the future.
FTC staff has identified deceptive practices by sellers of these sites. How Much? The products range in price, depending on the dose, but run between $1 to $3 per capsule per day. It appears that the more you buy, the better the deal. For example, a 30-day, a 1-month supply is $52.95; a 60-day, a 3-month supply is $126.95; and a 90-day, a 6-month supply is $205.95.
The FTC staff has also identified that many of the sellers of these products are making false claims that their products are the same as and approved by the FDA. These claims are false. FTC staff has identified deceptive practices by sellers of these sites. They have sent letters to the companies telling them to knock it off.
The FTC staff has identified dozens of websites that sell these products to date. The sellers include many different companies. The only shipping charge is $3.95 for the first item and $1.95 for each additional item. The companies will not bill your credit card until the package is shipped. Generally, it takes less than a week for the order to arrive.
The company will send you your first order for free. However, you have to pay for shipping after placing a second order. One site states that it is not a safety risk, but this is a stimulant, and it can cause insomnia in some people. When you are selling something, you want to ensure that your customer knows what they are buying and that what you are selling is safe.
Covidien sells some medical products, according to the company website. They include patient care products, diagnostic products, surgical products, and health management products. These items include two additional bottles for $6.95 each, not listed in the “shopping cart.”
Another issue of concern, according to the FTC, is the fact that many of the doctors who review these products on these sites are not real doctors.”It is a pretty common scenario where you see a doctor review a product,” said Dr. Verma. Still, that is much money, and you will not likely see any actual results. Chances are, you will lose money. The product has no scientific backing to support its claimed benefits. The amount of money you will pay for the product will outweigh its actual price.
What’s the Catch?
There are many complaints regarding poor customer service. Some even claim that the company has closed its doors and left them hanging. Although there is no official recall on Belly Trim, the company has shut down its website and no longer sells the product. You will have to pay for every phone call you make to customer service. It can become a very costly process trying to reach them.
You will likely have to pay for shipping as well, and there are many reports of the shipping taking up to three months to arrive. There is no way to find out how much a product will cost you until it is time to check out. People who want to return the product or switch to a different outcome are often met with resistance. Some companies do not accept returns or do not issue refunds, and customer service representatives are unresponsive. Also, there is a constant push to renew your membership.
In a perfect world, no one should be victimized by these companies. No one should deal with companies that do not care about the consumer. According to complaints, the company offers a 30-day money-back guarantee, but many people cannot get a refund. Cancel your order again after receiving the product, and you’ll be charged $150.
The website is full of reviews that complain about products that do not work, products that do not come, etc. You see, you are billed at the end of the month, but the products are not shipped until the month after. You ordered a package that was supposed to be suitable for thirty days. In the second month, you will stop receiving your shipment, and you will be charged for that month as well. This may appear as a one-time mistake, but many customers have complained about this.
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