Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm447670.htm
Timestamp: 2019-04-24 10:52:02+00:00

Document:
This is to advise you that the Food and Drug Administration (FDA) and the United States Federal Trade Commission (FTC) reviewed your web sites at the Internet addresses www.fenvir.com, www.herpescuresinvestigated.com, and www.strictlyhealth.com in March 2015 and has determined that you take orders there for the products FENVIR, Prosta Pep and Tonalin brand CLA. We have also reviewed your social media pages on Facebook, Tumblr, Pinterest, YouTube, and Twitter, which provide a link to your website at http://www.fenvir.com. Based on FDA's review, your websites and social media pages promote FENVIR, Prosta Pep and Tonalin brand CLA for conditions that cause these products to be 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)]. Further, FDA has reviewed your Fenvir product label and found that the product is misbranded within the meaning of section 403 of the Act (21 U.S.C. § 343).
The therapeutic claims on your web sites and social media pages establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introduction or delivering these products for introduction into interstate commerce for such uses violates the Act. You may find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
• “What is the chance I will pass the virus to my partner?
• “Does the FENVIR remedy treat both HSV-1 oral and HSV-2 genital herpes?
• “How likely is this product to work for me if the ones my doctor gave me failed to help?
Your 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 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 FENVIR, Prosta Pep and Tonalin brand CLA products are offered for conditions that are 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 these drugs safely for their intended purposes. Thus, these drugs are misbranded within the meaning of section 502(f)(1) of the Act, in that their labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. 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)].
1. Your Fenvir product label is misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.
2. Your Fenvir product is misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient extract in the product is derived, as required by 21 CFR 101.4(h)(1). For example, your product label declares “Prunella vulgaris 4:1 botanical extract and Amla (Emblica officinalis std. to 20:1 Phyllanthus emblica extract) as ingredients; however, the label fails to list the parts of the plant from which each botanical extract is derived.
The above violations are not meant to be an all-inclusive list of deficiencies in your products or their labeling. It is your responsibility to ensure that all of your products and labeling are in compliance with the FD&C Act and its implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials for all of your products to ensure that the claims you make for your products are not in violation of the FD&C Act.
You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to implement lasting corrective action of these violations may result in regulatory action being initiated by FDA without further notice. The FD&C Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products.
Please notify this office in writing within 15 working days from your receipt of this letter as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur in the future. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, please explain the reason for the delay and the date by which each such item will be corrected.
If you need additional information or have questions concerning any products distributed through your website, please contact the FDA. You may respond in writing to Tyra S. Wisecup, Compliance officer, at Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740. If you have any questions concerning this letter, please contact Ms. Wisecup at (240) 402-5854.
In addition, it is unlawful under the FTC Act, 15 U.S.C. § 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. See FTC v. Direct Mktg. Concepts, 569 F. Supp. 2d 285, 300,303 (D. Mass. 2008), aff'd, 624 F.3d 1 (1st Cir. 2010); FTC v. Nat'l Urological Group, Inc., 645 F. Supp. 2d 1167, 1190, 1202 (N.D. Ga. 2008), aff'd, 356 Fed. Appx. 358 (11th Cir. 2009); FTC v. Natural Solution, Inc., No. CV 06-6112-JFW, 2007-2 Trade Cas. (CCH) P75,866, 2007 U.S. Dist. LEXIS 60783, at *11-12 (C.D. Cal. Aug. 7, 2007). More generally, to make or exaggerate such claims, whether directly or indirectly, through the use of a product name, website name, metatags, or other means, without rigorous scientific evidence sufficient to substantiate the claims, violates the FTC Act. See In re Daniel Chapter One, No. 9239, 2009 WL 516000 at *17-19 (F.T.C. Dec. 24, 2009), aff'd, 405 Fed. Appx. 505 (D.C. Cir. 2010).
The FTC strongly urges you to review all claims for your products and ensure that those claims are supported by competent and reliable scientific evidence. Violations of the FTC Act may result in legal action seeking a Federal District Court injunction or Administrative Cease and Desist Order. An order also may require that you pay back money to consumers. Please notify FTC via electronic mail at healthproducts@ftc.gov within fifteen (15) working days of receipt of this letter, of the specific actions you have taken to address FTC's concerns. If you have any questions regarding compliance with the FTC Act, please contact David K. Koehler at 202-326-3627.

References: § 321
 § 343
 § 321
 § 355
 § 331
 § 352
 § 331
 § 343
 § 343
 § 41
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