The agency says a product marketed as a treatment for Ebola violates laws that require drugs to be approved by the FDA for safety and effectiveness
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.
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.