VitaPurity Corporation FDA Warning (2017)

Detailed Analysis

False Claims and Regulatory Violations

The FDA reviewed your website http://vitapurity.com in April 2017 and determined that you take orders there for the products Ellagic Ultra, Buffered Vitamin C Crystals, Coral Calcium with D3, Miracle Mushroom Blend, Lycopene 25 with Tomato Powder, Citral from Lemon Grass, and Pacific Ocean Shark Cartilage.  In addition, FDA reviewed your product labels.  The claims on your product labels and website establish that these products are drugs under section 201(g)(1)(B) of 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.

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

• “The American Cancer Society wrote that Ellagic Acid may, ‘reduce…birth defects … and promote wound healing’… They also pointed out that studies demonstrated Ellagic Acid inhibited {dangerous} cell growth and helped reduce the risk of chromosome damage.”• “Ellagic acid exhibits the ability to stop both {life-threatening} cellular changes and {malevolent} cellular mutations in humans.”• “VitaPurity Ellagic Ultra contains Green tea catechin extract…Green tea has been shown to …inhibit abnormal blood clot formation.”• “New studies suggest that Green tea may be especially protective against harmful {mutagenic} cells in the lungs of former and current cigarette smokers.”

Potential Health Risks

• “The Japanese College of Intravenous Therapy stated that, ‘People living in the affected areas should regularly take…vitamin C to counteract the negative consequences of long-term low dose radiation exposure…’”• “VitaPurity Also Offers Help Against the Flu”• “[R]ecommended VitaPurity Buffered Vitamin C Crystals as an important supplement to include with other antiviral medications.”• “Vitamin C is essential in healing scrapes, bumps & bruises…Vitamin C feeds the body’s production of antibodies…”• “[S]ufficient evidence exists to support the testing of intravenous Vitamin C for extended periods as a cytotoxic therapy agent, in doses high enough to maintain plasma levels sufficient to destroy {life-threatening} cells in the laboratory.”• “A significant percent of the ‘terminally ill’…patie

• “[I]ncreasing calcium intake can help maintain normal blood pressure in pregnant women.  Pregnancy-induced high blood pressure is a serious complication that can put both mother and child at risk.”• “Additional calcium intake may actually lower your risk for kidney stones.”

• Bucher, H.C., et al., Effect of Calcium Supplementation on Pregnancy-Induced Hypertension and Preeclampsia: A Meta-analysis of Randomized Controlled Trials, Journal of the American Medical Association, 275:14, 1996.• Sakhaee, K., et al., Limited Risk of Kidney Stone Formation During Long-Term Calcium Citrate Supplementation in Nonstone Forming Subjects, Journal of Urology, 152:324-327, 1994.

Regulatory Context

The United States Food and Drug Administration (FDA) conducted an inspection of your facility, located at 5246 Dobrot Way, Central Point, Oregon, from November 1, 2016, through November 4, 2016.  During our inspection, you informed our investigator that your firm holds and distributes dietary supplements that your contract manufacturer manufactures, packages, and labels under your own firm’s name.  We found serious violations of the Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111).  These violations cause your dietary supplement products Ellagic Ultra, Buffered Vitamin C Crystals, Coral Calcium with D3, Miracle Mushroom Blend, Lycopene

We collected product labels during the inspection for products you hold and distribute under your firm’s name, including Ellagic Ultra, Buffered Vitamin C Crystals, Coral Calcium with D3, Miracle Mushroom Blend, Lycopene 25 with Tomato Powder, Citral from Lemon Grass, and Pacific Ocean Shark Cartilage.  In addition, FDA reviewed labeling on your website http://vitapurity.com.  Based on our review, we have concluded that your products identified below are in violation of sections 502(f)(1) and/or 505(a) of the Act [21 U.S.C. §§ 352(f)(1) and/or 355(a)].  You may find the Act and FDA regulations through links on the FDA’s home page atwww.fda.gov.

Your products listed above are not generally recognized as safe and effective for the above referenced uses and, therefore, they 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 FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 321(d) and 355(a)].  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.