Since the beginning of the COVID-19 pandemic, the FDA and FTC have sent several hundred warning letters to companies and individuals allegedly selling products and services making misleading, deceptive, or scientifically unsupported claims about their ability to prevent, mitigate, or treat COVID-19, a topic we’ve covered before here on SBM. Apparently undeterred by the possibility of government action, advertising and selling of COVID-19 nostrums continues apace, aided and abetted in some cases by laws that invite such nefarious activities via lax regulation. Today we take a look at the government’s latest efforts to pursue COVID scofflaws.
(The FDA has jurisdiction over false and misleading labels and labeling of consumer products such as drugs, dietary supplements, and cosmetics. The FTC has jurisdiction over unfair and deceptive advertising in all its forms. The regulatory authority overlaps, hence warning letters are sometimes issued jointly. You can report a product to the FDA here and a product or service to the FTC here.)
Herbs, supplements, and other “natural” products
Dietary supplements, including herbal remedies, are only lightly regulated by the FDA, creating a fertile field for unsupported claims. As easy at this is to pull off, some marketers apparently have not learned the trick of sticking to claims that their products “boost the immune system“, thereby only implying that they are effective against COVID-19, while avoiding direct statements that they can prevent or treat it. Claiming the latter invites a warning letter from the FDA by making the product, in the eyes of the law, an unapproved new drug.
Per the FTC, a company cannot advertise that a product can prevent, treat, or cure a disease unless it has 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.
Only a handful of drugs have been shown to be effective in treating COVID-19 and, for now, there is no approved preventative on the market. This means that sending warning letters to marketers touting preventatives and cures is somewhat like shooting the proverbial fish in a barrel.
For example, Prairie Dawn Herbs, a Colorado firm, stepped over the line by recommending its herbal formulas “to help protect the immune system and combat symptoms of . . . covid . . .”, including Echinacea tincture, Echinacea glycerite, thieves oil, eucalyptus oil, mentholated salve, skin heal salve, and chest tea. And, while the Chinese government is busy promoting TCM for COVID-19, the U.S. government is not impressed. Thus, references to the fact that Chinese hospitals are using herbs to treat COVID is, fortunately, not dispositive of their effectiveness in the eyes of the FDA or FTC. This claim, among others, earned Griffo Botanicals a warning letter:
Did you know that hospitals in HuBei and WuHan published Chinese herbal guidelines for treatment of COVID-19 in its various stages and presentations? Griffo Botanicals has produced 4 new COVID formulas based on these guidelines. The intention of these formulas is to ease symptoms, while bringing the body back into balance. They promote recovery, improving both mild and moderate symptoms while reducing the inflammatory load on the lungs and other organs that occur during Covid-19 infection. . . .
Perhaps due to the gravity of COVID-19, the feds are targeting even small operators. The Tonic Therapeutic Herb Shop & Elixir Bar, of Shepherdstown, West Virginia, got a warning letter referencing an article that could be a tutorial on how to make illegal claims:
SARS-CoV-2 (COVID-19): HERBAL PROTOCOLS FOR THE TREATMENT OF INFECTION AND POST-CORONAVIRUS SYNDROME
The article recommends a plethora of unproven remedies to “help prevent infection and reduce the severity of symptoms”, including Japanese honeysuckle, Chinese skullcap, elderberry, licorice, Cordyceps (“also known as caterpillar fungus”), Astragalus, hyssop, thyme, elder flower, peppermint, red clover, Calendula, violet, nettle, mullein, chickweed, and medicinal mushrooms.
Aside from the violations of federal law, it seems clear that this collective of herbalists is treating disease, which, to my understanding, is limited to licensed health care professionals like physicians and nurse practitioners under West Virginia law. I could not find out whether West Virginia licenses the practice of herbalism or that the state has a so-called “health freedom” law.
A warning letter to Beephothocary, another small company, demanded they stop claiming its propolis, a substance produced by bees to build their hives, is an effective antiviral against COVID.
As you might imagine, the cure-all du jour, CBD, is also being monetized as a COVID treatment. A Las Vegas outfit called Senior Living, LLC, and its website, blueribbonhemp.com, got a warning letter for claims that CBD and NAC (n-acetyl cysteine) “Fight Viral Infections like Coronavirus”. Likewise, an Arizona company named (with the apparent intent of exploiting America’s affinity for the military) For Out Vets LLC, doing business as Patriot Supreme, was warned against promoting CBD as a treatment for lung inflammation caused by COVID.
Another au courant medical marvel, salt therapy, was the subject of a warning letter to a California firm, Oxford Medical Instruments, for claiming its salt inhaler, which “involves the process of breathing salty air through high-quality salt pipes that aids someone to reduce respiratory disorders especially during this era of coronavirus” can “ensure your respiratory tract is in the best condition to effectively fight the coronavirus pandemic and keep you healthy from other respiratory complications like pneumonia”.
Previous government warnings about claiming silver-containing products can effectively treat COVID notwithstanding, companies continue to promote these nostrums. Michigan company Spartan Enterprises (doing business as Watershed Wellness Center) received a warning letter for saying:
Today, Planes are arriving from China carrying one of the most deadly viruses every known, the Coronavirus. The best way to protect yourself against this is with liquid angstrom silver.
And, even more expansively:
Will silver, this kind of silver, kill that virus [i.e., the coronavirus]? Well yes! Silver will kill that virus. It will kill any virus, any bacteria, yeast, mold, and fungus, nothing can survive it. So, this means when you take this, the virus will be killed, well it might kill some of it.
A company called Silveryguy, which advertises on Amazon, was warned against hawking atomized colloidal silver, which “can be inhaled deep into the lungs, the action of silver colloids getting on the lining of your lungs may prove to inhibit the virus from replicating too quickly” and “may reduce your body’s overreaction to the virus”. A Georgia-based outfit, Peterson Research Laboratories, received a warning letter for making the following claim, which nicely displays the sort of sciency-sounding nonsense beloved by supplement pushers, plus a pitch to fringe practitioners who want to profit off selling COVID nostrums to their patients:
Simple Silver (Colloidal Silver) with ionic solubility technology is a dietary supplement that has ionic solubility that may supports the Immune system ability to fight off and kill nasty pathogens that can cause illnesses inside and outside the body such as: CORONAVIRUS (COVID-19) . . . Ideal for dedicated health care professionals working with Covid-19 patients . . .
Failure to adequately address similar unlawful claims following warnings has resulted in the FDA seeking injunctive and other relief in court. Most recently, at the request of the FDA, the U.S. Department of Justice filed a civil complaint for permanent injunction in a New Jersey district court against Natural Solutions and individual defendants for selling a “nano silver product” that defendants claim can treat or cure COVID-19.
Finally, the aptly-named Predator Nutrition, a British firm, was told to stop making COVID-related claims for its products, including salidroside, a bioactive component of the plant Rhodiola rosea, the “potential” of which was couched in life-saving terms:
. . . in ameliorating sepsis induced lung injury [footnote omitted], and protection against pulmonary fibrosis. [footnotes omitted] Attacking the lungs and causing pulmonary fibrosis is one of the most common symptoms seen in those for whom Covid-19 turns severe or fatal.
“Natural” products aren’t the only ones in trouble for false COVID marketing. The FDA recently went after companies selling pharmaceuticals as unproven COVID remedies.
According to the FDA, sales reps for Nephron Pharmaceuticals Corporation sent emails promoting Budesonide, an FDA-approved drug for the treatment of asthma in children, as a treatment for symptoms associated with COVID. In one email quoted by the FDA, a sales rep said that:
Over the last few weeks, doctors and researchers have touted the benefits of using Budesonide as a treatment for symptoms associated with COVID-19. One physician, who went viral this month, called Budesonide a “silver bullet”.
Two internet pharmacies, Medication-house.com (China) and Extrapharma.com (Russia), received warning letters in September regarding their sale of Arbidol, an antiviral used in some countries for influenza treatment but not FDA-approved in the U.S. because no application for approval has ever been filed. Both websites claim that Arbidol is effective in preventing COVID.
“Wellness” practitioners received FTC warning letters as well. The FTC cited New York City’s Tribeca Wellness Collective for promoting:
Thymosin Alpha 1 peptide therapy, Endolaser IV therapy, high dose vitamin C IV therapy, ozone IV therapy, vitamin B12 injections, and supplements. [references added]
I was intrigued by the “Endolaser IV therapy”. An endolaser is a medical device used in eye surgery, so I couldn’t imagine what an IV Endolser was. Here’s an “explanation” from Tribeca Wellness:
So the reason that we use the IV Endolaser is because specifically the red light helps to support your body’s natural immune system. So it supports natural killer cells, T helper cells, and T suppressor cells, which are all cells that your immune system uses to keep you healthy, recognize foreign invaders, as well as kill them, and alert your body that you’re being invaded, and the appropriate response to that.
I must confess I still have no idea how this works. In any event, according to the FTC, there is no reliable scientific evidence it works for COVID.
Park Avenue Skin Solutions, whose address is one floor above Tribeca Wellness (and is therefore, in fact, not on Park Ave.) was cited in an FTC warning letter for similar claims.
But for sheer volume of unsubstantiated COVID claims catalogued in an FTC warning letter, I have not found anything to beat MD Beauty Labs in West Palm Beach, Florida. MD Beauty Labs advises that
It only makes sense that we should boost our immune system so that we can improve our chances to fight off disease.
In addition to Thymosin Alpha-1 there are several other IV Therapies and Supplements that are beneficial. [They are] IV Vitamin C Therapy – Helps the immune system and possibly inhibit viral replication; IV Glutathione Therapy – Powerful Antioxidant; IV Colloidal Silver Therapy – Antimicrobial and Immune Boost; AHCC- Japanese Medicinal Mushroom Extract – Supports Immune Function; Vitamin D3 – Helpful to enhance immune function; Path DS – Provides a powerful combination of herbs to naturally support a healthy immune system. Liposomal Vitamin C; Liposomal Glutathione; Liposomal Curcumin; Melatonin – Has been found to have anti-viral properties; Wellness Tonic- A blend of medicinal herbs that help boost the immune system; PRP spray – Purified Immunoglobulins from cow’s colostrum; Zinc – Supports immune system. We also have an Immune Support kit, containing mineralized D3, Liposomal Vitamin C, Zinc and Immuno PRP Spray. [Reformatted from original.]
The FDA and FTC have responded to the gravity of the pandemic by more aggressively pursuing unlawful claims that products and services can treat or cure COVID-19. It is unfortunate that they do not have the resources to mount this type of campaign against more pedestrian bogus remedies, which remain on the market to bilk the public.