The Federal Drug Administration regulates drugs, dietary supplements, medical devices, and cosmetics. When companies that manufacture and sell products that promise to prevent, treat, cure, or diagnose diseases, those claims raise a red flag. FDA will investigate the claims to determine if the claims indicate the products are misbranded or if the products are unapproved drugs.
FDA oversight has expanded due to the COVID-19 pandemic. Companies that promise their products can treat the disease or prevent the disease will likely be sent a warning letter because there is no current treatment or vaccine for COVID-19. Some companies directly claim they can treat or prevent the disease. Other companies are promising that they can build up the body’s immune system as a way of treating or preventing the disease.
Experienced FDA healthcare lawyers understand the Food, Drug, and Cosmetic Act and FDA regulations. They help prepare compliance plans to reduce the risk of FA warning letters being sent. They also help manufacturers and sellers understand how to respond to FDA warning letters. Failure to respond to an FDA warning letter can result in lawsuits that can force a company to cease making and selling the products and force the business to pay fines, penalties, and damages for noncompliance.
New York’s Attorney General initiated the investigation against major retailers of herbal supplements, based on DNA testing of plant materials suggesting contaminants, and mislabeling; was the […]
Joint FTC and FDA warning letters
Some of the letters are joint FTC and FDA warning letters. These letters claim the companies who receive the letters are allegedly selling products that are not approved. The products and claims may be prohibited by federal law because the claims are deceptive and don’t have scientific support regarding their ability to cure or treat COVID-19.
On March 9, 2020, the FTC and FDA issued warning letters to seven businesses making claims that their products can treat or prevent COVID-19. The agencies asserted that the seven companies may be in violation of federal law. The letters are the first warning letters issued by the agencies regarding COVID-19 claims that are not approved and/or not supported by scientific evidence.
The letters claim that the companies advertised essential oils, teas, and colloidal silver as being able to treat or cure coronavirus even though FDA asserts there are no proven drugs, vaccines or investigational products currently available for the disease.
The seven companies that were sent letters were:
- Vital Silver
- Quinessence Aromatherapy Ltd.
- GuruNanda, LLC
- Vivify Holistic Clinic
- Herbal Amy LLC
- The Jim Bakker Show
FTC Chairman Joe Simons stated that the warning letters for preying on the fears of consumers are just the first step. Companies that fail to take appropriate actions for fraudulent claims will be subject to enforcement actions for continuing “this type of scam.” Enforcement actions include seeking federal court injunctions to force the companies to remove the claims and federal court orders to pay consumers any funds they submitted for the products.
FDA Commissioner Stephen M. Hahn, M.D. added that:
“The FDA considers the sale and promotion of fraudulent COVID-19 products to be a threat to the public health. We have an aggressive surveillance program that routinely monitors online sources for health fraud products, especially during a significant public health issue such as this one.”
The respondents were given just 48 hours to respond as to what corrective measures they were taking to correct the unlawful violations.
FTC and FDA both monitor company websites, social media accounts, online marketplaces, and complaints from consumers regarding fraudulent marketing.
The FTC created a consumer blog called Coronavirus: Scammers follow the headlines to help consumers identify coronavirus-related scams that make false claims about the virus, and use “fake emails, texts, and social media posts as a ruse to take consumers’ money and get their personal information.”
FDA warning letter issued to Free Speech Systems LLC d.b.a. Infowars.com
On April 9, 2020, the FTC and FDA issued a warning to the company that its COVID-19 products were misbranded and unapproved based on a review of the company websites. FDA determined that the following products were intended to “mitigate, prevent, treat, diagnose, or cure COVID-19.” The products are unapproved drugs and are misbranded drugs in violation of Sections 505 (a) and 502 of the FD&C Act. Introducing the products into interstate commerce violates sections 301 (a) and d of the F&C Act.
The identified products are:
- “Superblue Silver Immune Gargle,”
- “SuperSilver Whitening Toothpaste,”
- “SuperSilver Wound Dressing Gel”
- Superblue Fluoride Free Toothpaste”
Some of the claims on the videos posted on the company websites that are deemed misleading and establish the medical use of the products for the treatment and prevention of COVID-19 are:
- A video posted on 3/10/2020, titled “Alex Jones Deep States: Using Coronavirus Fear and Panic To Destroy Our Country.”
- At minute 13:25, you state: “[R]egardless of how deadly this virus is . . . if it kills you, it’s bad news. So, I would advise listeners, just for your everyday life anyway to boost your immune system.”
- “We have the products that are documented on record to be good for your body. I mean Nano Silver is on record taking out viruses and bacteria. It’s in our entire line of high quality silver products and it’s patented, it’s amazing, it’s in the Super Silver Wound gel, it’s in the Super Silver Toothpaste, it is in the Super Blue Toothpaste . . . we’re very close to selling out in infowarsstore.com . . . ”
- A video posted on 3/10/2020, titled “Experts Say Trump Must Seal the Border like Israel & Italy or Face Massive Coronavirus Surge.”
- At minute 31:08, you state “I’m not going to belabor this, I’m just gonna tell ya, that for just your daily life, and your gums and your teeth and for regular viruses and bacteria, the patented Nano Silver we have, the Pentagon has come out and documented, and homeland security have said this stuff kills the whole SARS corona family, at point blank range. Well of course it does, it kills every virus. But they found that, this is 13 years ago, and the Pentagon uses the product we have.”
- “And the product we have in private label is about to be in Walmart . . . the Nano Silver toothpaste in the Superblue with the tea tree and the iodine, that’s the Superblue’s amazing, and we have the whitening toothpaste that has the Nano Silver and a lot more as well . . .they are at infowarsstore.com”
- A YouTube video on the company website that was posted on 2/9/2020, titled “Coronavirus – Is This The Virus that DIDN’T Cry Wolf?” states:
- At minute 2:30, “we’re independently sponsored by InfoWars” and at minute 3:50, “If you are concerned about the Coronavirus or the Flu or the common cold, then I recommend you to go to the Infowars store, pick up a little bit of silver that really acts its way to boost your immune system and fight off infection . . .” At minute 3:58, the video shows your Superblue Silver Immune Gargle product.
The company was advised to take immediate steps to correct the FD&C Act violations. The joint FDA and FTC warning letter advised the company to review any other possible violations on its websites, product labels, or other labeling and promotional materials
The warning letter gave the company 48 hours to respond or to explain why more time was needed and how much time was needed. The company was also advised that additional enforcement action may be taken if the company failed to comply.
If you’re a dietary supplement manufacturer or distributor, know that FDA and FTC now encourage the public to report dietary supplement labeling violations.
FDA warning letter issued to JRB Enterprise Group Inc. DBA Anti-Aging Bed
On March 30, 2020, FDA sent a warning letter to JRB Enterprise Group Inc. DBA Anti-Aging Bed, a South Carolina company, stating that after reviewing the company’s Twitter account and company website, FDA determined that the company’s colloidal silver products are unapproved new drugs because they are “intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people” – in violation of section 505 (a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a).
FDA stated that the products are also in violation of the FD&C Act because they are misbranded and that introducing or delivering for introduction the products into interstate commerce is not legal according to the FD&C Act. The company was advised to cease the sale of these unapproved and misbranded products immediately.
The statements and claims that formed the basis of the FDA complaint included the following:
- “CoronaVirus Pandemic – History 100 Years in the Making . . . Colloidal silver is an excellent natural remedy for a variety of lung problems including bronchitis, lung infections, and COPD. While colloidal silver can be used orally to treat some lung problems, delivering the colloidal silver directly to the lungs is the optimum way to treat most lung issues. . . . Colloidal Silver in a Nebulizer, the type that is commonly prescribed by medical professionals for asthmatics and those with chronic lung problems, as a medium to deliver colloidal silver to the lungs, provides a real prevention regimen for a number of maladies – including the Corona Virus known as COVID19.”
- “Colloidal Silver CoronaVirus Convenience Package . . . PLUS the A2B reusable nebulizer to get the powerful anti-viral solution into the lungs, throat, and sinuses!”
- “Utilize colloidal silver with a nebulizer to get the silver solution into your lungs, throat and sinus immediately during the times of Coronavirus outbreak!”
- “CoronaVirus Pandemic . . . #coronavirus #flu #treatement[sic] #prevention #silver . . . antiagingbed.com
- “CoronaVirus Protection & Prevention Care Package . . . Colloidal Silver Coronavirus Convenience Package”
JRB Enterprise Group Inc. DBA Anti-Aging Bed was given 48 hours to correct the violations and to review its websites, product labels, and promotional materials for any other violations. Alternatively, the company could give FDA a timeline for reply and reasons for the delayed response.
FDA also informed the company that the company would be added to the FDA website’s list of firms that had received warning letters. If corrective steps are taken that are satisfactory to FDA, the website will be updated to indicate that corrective measures were taken.
If the company failed to take corrective steps, FDA explained that the agency might take legal action including, without limitation, seizure, and injunction.
FDA explained that, additionally, 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.” Since there are no current treatments or prevention methods for COVID-19, the company was informed FTC could also seek legal action in federal court.
FDA warning letters have been sent to manufacturers, sellers, and marketing companies that promote products capable of treating, preventing or curing COVID-19. The letters were sent in March and April of 2020 and more are expected to follow. Since there are no current known treatments or cures for COVID-19, claims that products can provide effective medical help are causing FDA warning letters to be sent on the basis that the products are not approved drugs and are misbranded.
Contact Cohen Healthcare Law Group, PC for legal counsel on healthcare transactions, regulatory compliance, and FDA and FTC law. Our experienced healthcare & FDA attorneys advise healthcare companies and healthcare providers ranging from medical centers, to integrative and functional medicine practices, cosmetics and supplement companies, and medical device manufacturers.