Thursday, January 1, 2015

Public Service Announcement: Beware Fake "Ebola Survival Kit" Purveyors

Back in November of 2014, the FDA and the FTC jointly sent a warning letter to an outfit called, LLC, out of Clearwater, Florida [more specifically at 301 Turner Street, phone: (727) 441-4954], directing the owner of the site to stop selling its products under what amount to false pretenses. [At about the same time, both Ebola-C Inc. and LifeSilver (Patis) received similar warning letters.] I note all three here, on the first day of 2015 -- because people who prey on the fears of the populace (with snake oil offers) really raise my hackles. Especially so, given the number of serious scientists devoting long and often thankless hours -- to actually finding a solution to the real problem of ongoing Ebola infections, globally.

So in my opinion, these companies deserve the derision I now gleefully heap upon them. Steer clear folks -- from the FDA's warning letter to BodyHealth, LLC then -- the relevant bit(s):

. . . .This is to advise you that in October 2014 the U.S. Food and Drug Administration (FDA) and the United States Federal Trade Commission (FTC) reviewed your website. . . from which you take orders for your product, "BodyHealth Optimum Health Survival Kit". . . .

On your home page, you have a banner which states "Worried about Ebola? . . .Here are some suggestions of things you can do to stay proactive. . . ."

. . .[Y]our "BodyHealth Optimum Health Survival Kit" product page . . .states that "The Optimum Health Survival Kit provides a proactive solution to help fight against Ebola or any other viral outbreak scare". . . .

The claims quoted above are supplemented by the metatag keywords used to bring consumers to your website through Internet searches. The metatag keywords include: “ebola,” “ebola virus,” and “ebola scare.”

Your “BodyHealth Optimum Health Survival Kit” product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a “new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

Furthermore, your product identified above is offered for a condition that is not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use this drug safely for its intended purposes. Thus, this drug product is misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that its labeling fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].

The marketing and sale of unapproved or uncleared Ebola Virus-related products is a potentially significant threat to the public health. Therefore, FDA is taking urgent measures to protect consumers from products that, without approval or clearance by FDA, claim to diagnose, mitigate, prevent, treat or cure Ebola Virus in people. . . .

It seems BodyHealth, LLC has removed the pages from its website, but anyone who runs into similar scam-laden, fear-based marketing pitches ought to report the same, here. Namaste, and have a safe and happy 2015, one and all!

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