FDA Issues Another Round of COVID-19 Claim Warning Letters
05.27.20
Companies selling vitamins, CBD, and unapproved drug products have been accused of claiming their products can remedy COVID-19.
Throughout the progression of the COVID-19 pandemic, the U.S. Food and Drug Administration has intermittently issued warning letters to companies accused of promoting products, claiming that such unapproved products can cure, prevent, or treat the disease caused by the virus. In the latest round, the agency targeted companies selling vitamin C and D products, CBD, other suppelments, and even a new unapproved drug product that FDA considers to be an unlicensed biological product. A total of seven companies received warning letters in this round.
North Coast Biologics was allegedly selling a product called “nCoV19 spike protein vaccine,” and that this product was intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. The product, according to FDA, is a misbranded drug which is illegal to introduce into interstate commerce. Additionally, the product is an unlicensed biological product. FDA cited a number of posts by the company’s owner, which appear to convey that the product has been marketed as a vaccine to COVID-19.
Apollo Holding LLC received a letter from FDA regarding a line of products it was allegedly purporting to be a coronavirus cure, “NoronaPak” products, which included CBD and a number of supplement products. FDA cited a number of social media posts linked to the company that it considered to be violations.
Roidsmall.net was advised that its website offers drug products for sale in the U.S. which are intended for COVID-19 applications in people. The company allegedly sold misbranded and unapproved drugs, which don’t carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. These drugs for sale received no prior approval from FDA for any applications, or introduction into interstate commerce. In particular, the drugs allegedly marketed as Coronavirus remedies were lopinavir, ritonavir, and oseltamivir.
Emedkit.com received a similar warning letter from FDA regarding the sale of a drug product which combines lopinavir and ritonavir, in which FDA asserted that the company marketed these drugs as an effective treatment for COVID-19.
4rnx.md received a warning letter from FDA due to its online listing of lopinavir, ritonavir, hydroxychloroquine sulfate, and ribavirin under the heading “Coronavirus treatments. Additional statements purporting that these unlicensed drugs could be used to treat COVID-19 were made on the site, FDA said. On April 24, FDA issued a communication cautioning against the use of hydroxychloroquine or chloroquine for COVID-19 outside of a hospital setting or clinical trial investigating the use of the drug due to its adverse side effects such as serious heart rhythm problems.
Life Unlearned, LLC, a publication specializing in nutrition on lifeunlearned.com, received a warning letter from FDA following the alleged promotion of vitamin D products on its website. FDA observed that the company participates in the Amazon Associates program, meaning that the company earns commissions by promoting the sale of vitamin D products. These promotions allegedly included claims that vitamin D can mitigate, prevent, treat, or cure COVID-19, with posts titled “New Study Reveals Vitamin D May Be the Key to COVID-19,” “Vitamin D Has Never Been More Important,” and Life Unlearned’s Trusted Vitamin D Products.”
Additionally, Spicetac.com, which appears to sell gun parts, is also an Amazon Associate, and had earned commissions promoting the sale of vitamin C, and the site included claims that it can treat COVID-19. Additionally, FDA reports that these claims cause the Amazon associate product purchased through links on the site to be an misbranded, unapproved new drug.
Each letter issued by the FDA requests that companies take immediate action to corret the violations they list, and that the letter is not an all-inclusive list of violations that exist for each business. FDA warns that the violations may result in legal action, including seizure and injunction. Each company was reqeusted to respond within 48 hours to the FDA’s COVID-19 Task Force to provide the corrective actions taken.
North Coast Biologics was allegedly selling a product called “nCoV19 spike protein vaccine,” and that this product was intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. The product, according to FDA, is a misbranded drug which is illegal to introduce into interstate commerce. Additionally, the product is an unlicensed biological product. FDA cited a number of posts by the company’s owner, which appear to convey that the product has been marketed as a vaccine to COVID-19.
Apollo Holding LLC received a letter from FDA regarding a line of products it was allegedly purporting to be a coronavirus cure, “NoronaPak” products, which included CBD and a number of supplement products. FDA cited a number of social media posts linked to the company that it considered to be violations.
Roidsmall.net was advised that its website offers drug products for sale in the U.S. which are intended for COVID-19 applications in people. The company allegedly sold misbranded and unapproved drugs, which don’t carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. These drugs for sale received no prior approval from FDA for any applications, or introduction into interstate commerce. In particular, the drugs allegedly marketed as Coronavirus remedies were lopinavir, ritonavir, and oseltamivir.
Emedkit.com received a similar warning letter from FDA regarding the sale of a drug product which combines lopinavir and ritonavir, in which FDA asserted that the company marketed these drugs as an effective treatment for COVID-19.
4rnx.md received a warning letter from FDA due to its online listing of lopinavir, ritonavir, hydroxychloroquine sulfate, and ribavirin under the heading “Coronavirus treatments. Additional statements purporting that these unlicensed drugs could be used to treat COVID-19 were made on the site, FDA said. On April 24, FDA issued a communication cautioning against the use of hydroxychloroquine or chloroquine for COVID-19 outside of a hospital setting or clinical trial investigating the use of the drug due to its adverse side effects such as serious heart rhythm problems.
Life Unlearned, LLC, a publication specializing in nutrition on lifeunlearned.com, received a warning letter from FDA following the alleged promotion of vitamin D products on its website. FDA observed that the company participates in the Amazon Associates program, meaning that the company earns commissions by promoting the sale of vitamin D products. These promotions allegedly included claims that vitamin D can mitigate, prevent, treat, or cure COVID-19, with posts titled “New Study Reveals Vitamin D May Be the Key to COVID-19,” “Vitamin D Has Never Been More Important,” and Life Unlearned’s Trusted Vitamin D Products.”
Additionally, Spicetac.com, which appears to sell gun parts, is also an Amazon Associate, and had earned commissions promoting the sale of vitamin C, and the site included claims that it can treat COVID-19. Additionally, FDA reports that these claims cause the Amazon associate product purchased through links on the site to be an misbranded, unapproved new drug.
Each letter issued by the FDA requests that companies take immediate action to corret the violations they list, and that the letter is not an all-inclusive list of violations that exist for each business. FDA warns that the violations may result in legal action, including seizure and injunction. Each company was reqeusted to respond within 48 hours to the FDA’s COVID-19 Task Force to provide the corrective actions taken.
