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Ebola

FDA is cracking down on unproven Ebola cures

By
TIME
TIME
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By
TIME
TIME
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September 24, 2014, 4:04 PM ET
Medical staff put on protective gear in Kenema government hospital before taking a sample from a suspected Ebola patient in Kenema
Medical staff put on protective gear in Kenema government hospital before taking a sample from a suspected Ebola patient in Kenema, July 10, 2014. Ebola has killed 632 people across Guinea, Liberia and Sierra Leone since an outbreak began in February, putting strain on a string of weak health systems facing one of the world's deadliest diseases despite waves of international help. Picture taken July10, 2014. REUTERS/Tommy Trenchard (SIERRA LEONE - RTR402SPTommy Trenchard—Reuters

This post is in partnership with Time. The article below was originally published at Time.com.

By Alice Park, TIME

On Sept. 23, the Food and Drug Administration (FDA) issued a warning letter to Rima Laibow and Ralph Fucetola of Natural Solutions Foundation informing them that the company’s products, including Silver Sol Nano Silver and High Potency CBD Hemp Oil, which are marketed as Ebola treatments, violate the Federal Food, Drug and Cosmetic Act.

Based on the claims made on the company’s website as well as in a YouTube video, the FDA says the products are marketed as drugs, and therefore fall under the agency’s jurisdiction.

In the letter, the FDA notes

Your “Personal Protection Pack,” “Family Protection Pack,” “Dr. Rima Recommends™ The Silver Solution,” and “CBD Organic Dark Chocolate Bars” products are not generally recognized as safe and effective for the above referenced uses and therefore, these products are “new drugs” 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.

The company’s claims about its Ebola treatments also violate Federal Trade Commission laws, which prohibit advertising that a product can prevent, treat or cure human disease without reliable and valid scientific evidence.

In the past month, the World Health Organization as well as the FDA have warned consumers about such unproven therapies. Both remind the public that there are no known cures or treatments for Ebola; the therapy received by a handful of care workers in the U.S. Are still considered experimental and only used as an exception to the agency’s usual drug approval process.

The company has 15 days to correct the violations, or face legal action and seizure of the products.

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