Is Vacunda & Design Safe? FDA Warning Letter Review (2017)

Detailed Analysis

False Claims and Regulatory Violations

The claims on your websites establish that these products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. 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’s regulations through links on FDA’s homepage athttp://www.fda.gov.

Examples of some of the claims that provide evidence that your products are intended for use as drugs include:

We also note that you make claims regarding the purported health effects of CBD on your Facebook page at https://www.facebook.com/galemandist/posts/552633521604755. These claims provide evidence that both your Sinai Cannabis Oil and Sinai Soursop + CBD products, which are labeled to contain CBD as an ingredient, are intended for use as drugs. Examples of such claims include:

Potential Health Risks

The United States Food and Drug Administration (FDA) conducted an inspection of your facility, located at Avenida Muñoz Rivera # 269 Camuy, Puerto Rico on February 17 and March 1, 2016. During the inspection our investigators collected promotional material, product labels and labeling of your Sinai Cannabis Oil, Sinai Soursop Oil, and Sinai Soursop + CBD products. In addition, the FDA subsequently reviewed your websites in October 2016 at the internet sites http://www.vacunda-sinai.com/index.html, https://www.healthyforlifepr.com/, and your social media website https://www.facebook.com/Vacunda-Sinai-366017686756012/info/. We determined that you take orders at https://www.healthyforlifepr.com/ for the Sinai Cannabis Oil, Sinai Soursop Oil, and Sinai Soursop + CBD products. Further, your Fac

4. From the website www.healthyforlifepr.com at https://www.healthyforlifepr.com/collections/guanabana/products/cannabis-guanabana?variant=20122849603, regarding your Sinai Soursop + CBD product:

The existence of substantial clinical investigations regarding CBD has been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex.1 FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under FDA’s regulations (21 CFR 312.2), unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act. FDA is not aware of any evidence that would call into question its current conclusion that CBD products are excluded from the dietary supplement definition under section 2

Regulatory Context

Ideal for hyperactive kids with attention deficit and ADD

Your Sinai Cannabis Oil, Sinai Soursop Oil, and Sinai Soursop + CBD products are not generally recognized as safe and effective for the above referenced uses and therefore, the 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 sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.