National Consumer Protection Week: FDA cracks down on GMP violations and COVID-19 fraud
05 Mar 2021 --- With National Consumer Protection Week coming to a close, US supplement manufacturers have received stern reminders of the importance of following the US Food and Drug Administration (FDA)’s food safety regulation.
A federal court has ordered New York-based Confidence USA to comply with federal dietary supplement current good manufacturing practice (cGMP) regulations, having violated FDA Federal Food, Drug, and Cosmetic Act (FD&C Act) requirements.
This week, the FDA also issued three warning letters to companies whose products are marketed as COVID-19 treatments. One, named Ageless Global, produces vitamin C-based supplements and the other two companies offer thermal cameras measuring body temperature.
“We never meant to be deceptive and, until we read the FDA’s letter, did not think we were,” Darran Lopez, co-founder of Ageless Global, tells NutritionInsight.
“Regardless, we are working with regulatory authorities to ensure our message and label are properly received by the public.”
“The bottom line is that we are taking the corrective measures and look forward to our customers continuing to use our products,” adds co-founder Dan Schmidt.
To educate the public on consumer rights, National Consumer Protection Week has hosted a series of online events via social media platforms.
No confidence in Confidence USA?
Although not accused of COVID-19 fraud, Confidence USA “repeatedly failed” to verify the identity of each dietary ingredient used in its manufacturing, according to multiple FDA inspections.
To date, the FDA has uncovered nearly 1,300 fraudulent products and sent over 160 warning letters to remove listings for fraudulent COVID-19 products. The FDA also maintains the defendants failed to verify their products met specifications for purity, strength, composition, and contamination limits.
“Consumers deserve access to dietary supplements that are manufactured to assure their quality,” says McMeekin.
“If a dietary supplement company repeatedly fails to comply with GMP requirements, the public cannot trust their products are what they say they are. The FDA will continue to protect US consumers by taking appropriate actions necessary when companies violate the law.”
Until the US Food and Drug Administration (FDA) allows resumed operations, the company must stop manufacturing, holding, or distributing any food or dietary supplements.
Confidence USA will be required to hire an independent expert to ensure that they are following the cGMP regulations.
Following the court order, the FDA affirms that once the defendants resume operations, they must retain an independent auditor to ensure that they continue to follow the cGMP regulations.
NutritionInsight has reached out to Confidence USA for comment.
Examples of misleading claims
Since the beginning of the pandemic outbreak, nutrition “scammers” have tried to cash in on coronavirus fears. NutritionInsight has covered US crackdowns on COVID-19 “cures” ranging from teas and essential oils to colloidal silver and even chlorine dioxide.
While there has been much scientific debate and investigation in the role of vitamin C to lower the risk of COVID-19 mortality, there is no scientific evidence the vitamins can prevent or treat the virus altogether.
The FDA issued a warning letter to Ageless Global, which markets its products “Immunoral,” “Immune Plus,” “MD Immune Support Spray,” and “MD CVK-365 Mouth Spray” as “intended to mitigate, prevent, treat, diagnose or COVID-19,” according to the FDA.
Some examples of “misleading claims” include:
- “Immunoral is a therapeutic combination of CBD, nano-silver, specialized mineral oxide NSF-60 water, and Vitamin C that show promise to naturally defend against the current SARS-CoV-2 pathogen, the cause of COVID-19 in the body.”
- “Tested and affordable, Immune Plus Mouth Spray supports natural immune defense to inactivate, attack and shield against foreign pathogens like COVID-19, to safeguard your health.”
“We are scrubbing the websites and social media regarding our mouth sprays in regard to COVID-19 as requested,” says Schmidt.
He affirms his company’s sprays had over 100 clinical tests prior to receiving the FDA letter. “We understand now that since it was not tested on the [novel coronavirus] internally and done with mostly in-vitro studies, we needed to update our language to be more clear,” Lopez adds.
Ageless Global is currently listed on the FDA’s list of companies that have received warning letters. The published list will be updated to indicate the company has taken corrective actions once taken by Ageless Global and confirmed by the FDA.
The 23rd annual National Consumer Protection Week is held February 28 to March 6, 2021, sharing consumer rights information online.The health risks for consumers
National Consumer Protection Week is a coordinated campaign designed to focus on the importance of keeping consumers informed while providing them with free resources explaining their rights in the marketplace.
It is organized in partnership between the Federal Trade Commission and more than 100 US federal, state and local agencies, consumer groups, and national advocacy organizations.
This year, the participating parties have hosted a series of events including webinars, Facebook Live streams and Twitter chats throughout the week. These virtual events cover topics including avoiding coronavirus scams, government imposters and cyber fraud.
It is illegal in the US to market vitamins and other dietary supplements as treatments or preventions for any medical issue or disease, let alone COVID-19.
“Unproven products purporting to prevent or treat COVID-19, made from unknown substances under unknown conditions, present significant health risks in and of themselves,” McMeekin stresses.
“They can also lead consumers to make lifestyle choices that increase their risk of infection with COVID-19 or to delay or stop appropriate medical treatment.”
NutritionInsight has covered the FDA’s many efforts to eliminate misleading nutritional products from the market via its regularly updated COVID-19 news feed.
By Anni Schleicher
