Tag Archive for Warning Letter

FDA Sends Perfectly Posh A Warning Letter

The USA Food and Drug Administration has send Perfectly Posh and CEO Ann Dalton a warning letter, which is considered widely as a marketing nightmare.
The FDA:
Dear Ms. Ann Dalton:
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.perfectlyposh.com/p/ in March 2017 and has determined that you take orders there for the products Share Skin Joy Coconut Oil, Goodnight Kisses Overnight Lip Mask, Purifier Snarky Bar, Call it a Night Nighttime Facial Oil, and Lemon Wedgie Caffeinated Lip Balm.
The claims on your website establish that the products are drugs under section 201(g)(1)(B) and/or (g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B) and/or (g)(1)(C)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease and/or are articles intended to affect the structure or any function of the human body. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
Examples of some of the website claims that provide evidence that your products are intended for use as drugs

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Recall: The FDA did NOT Send Recently A Warning Letter To DoTerra And Young Living

 
Yesterday one of our editors posted the news both DoTerra as Young Living Essential Oils had received a FDA warning letter.
Both companies have indeed received such a letter however one year ago, in september 2014. Our editor did not check the source. We apologize for this outdated information.
Both companies have worked well with their compliance teams, and have received no further warnings from the FDA.
The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health.
The Warning Letter is the FDA’s principal means of notifying regulated industry of violations and achieving prompt voluntary correction.
The United States Food and Drug Administration (FDA) defines

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FDA Issues Warning Letters To Reprimand False Claims

 
Young Living and doTERRA distributors were reprimanded after the Food and Drug Administration FDA issued warning statements via overnight delivery to CEO Gary Young and David Stirling. Young Living and doTERRA both use independent distributors as a sales-force.
The majority of complaints the FDA issued in the warning letters involved the way some independent distributors marketed the companies’ products. Primarily, the FDA was concerned with Young Living and doTERRA consultants’ online marketing material for the brands’ essential oils.
According to FDA regulations, neither dietary supplements nor essential oils are allowed to be marketed by the company that sells them in such a way that it appears as though the products can prevent, cure or treat any disease. If a company does market in that manner, the product is considered a drug by the FDA. If a product is a drug, it must be approved by the FDA. So, any product marketed to cure, treat or prevent a disease, that is not already an FDA approved drug, is considered an illegal, unapproved drug by the FDA.
The FDA found that Young Living essential oils were marketed for “viral infections (including ebola), Parkinson’s disease, autism, diabetes, hypertension, cancer, insomnia, heart disease, post-traumatic stress disorder

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