U.S. FDA Red Flags Careful Cents, LLC for COVID-19 Claims

May 30th, 2020
Rachel Grabenhofer
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'Essential oils have many, many uses and a wide variety of treatments to help fight viruses,' Careful Cents, LLC, states on its website. 'You can use them for preventative care before getting sick and ongoing immune system support. Using the right blends of essential oils is an important part of making it through the coronavirus season healthy.'

Claims such as these caught the watchful eye of the U.S. Food and Drug Administration (FDA), and at the moment, the agency is especially focused on targeting consumer goods claiming to mitigate, treat or prevent the coronavirus. In response, the FDA issued a warning letter to the company on May 27, 2020, advising the company to take action to correct the violations outlined therein.

See related: Labeling Claims

The letter states, "This is to advise you that the ... FDA and the Federal Trade Commission reviewed your website at the Internet address https://abeginnersguidetoessentialoils.com on May 6, 2020, and May 19, 2020, respectively. While reviewing your website, FDA observed ... claims on your website representing or implying that the [essential oil products sold through your site] can mitigate, prevent, treat, diagnose or cure COVID-19 in people.

"Based on our review, these claims cause the ... products purchased through links on your website to be unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a)..."

The letter continued, "We request that you immediately cease promoting and participating in the sale of such unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis or cure of COVID-19."

See related: 6 Legally Binding Criteria for EU Product Claims

'We request that you immediately cease promoting and participating in the sale of such unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis or cure of COVID-19.'

Additional product claims cited in the letter include:

  • “Can you use essential oils to boost your immune system and fight coronavirus? Yes! Essential oils are one of the best tools to strengthen your immune system naturally...”
  • “HOW TO BOOST YOUR IMMUNE SYSTEM NATURALLY”
    • “Use top antibacterial essential oils to kill gems”
    • “Diffuse essential oil blends for immune support”
    • “Try this essential oils immunity recipe blend”
  • “Tea Tree ... essential oil is considered to have potent antimicrobial properties. It aids in fighting against ... viruses”
  • “You already know that Citronella ... is also an ... antiviral essential oil.”

The agency underlined its letter was not meant to be an all-inclusive list of violations, and it reminded the company that it is its responsibility to ensure its products do not violate the FD&C Act. "We advise you to review your websites and other labeling and promotional materials to ensure that you are not misleadingly representing your ... products as safe and effective for a COVID-19-related use for which they have not been approved by FDA and that you do not make claims that misbrand the products in violation of the FD&C Act."

For more information, visit the FDA website.

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