| UNITED STATES OF AMERICA FEDERAL TRADE COMMISSION BUREAU OF CONSUMER PROTECTION WASHINGTON, D.C. 20580 | DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION WASHINGTON, D.C. 20740 |
April 28, 2011
WARNING LETTER
Ms. Lesa Sverid
PO Box 865
East Wareham, MA 02538
Dear Ms. Sverid:
This letter is to advise you that the United States Food and Drug Administration (FDA) and the United States Federal Trade Commission (FTC) have reviewed your website at the Internet address www.neveranoutbreak.com. The FDA has determined your firm’s marketing of the products O2xygen Force (also referred to as Oxygen Force, OxyForce, and Oxy2), DMSO Cream, DMSO Roll-on, DMSO Cream w/Aloe, and AlkaLife, which are offered for sale on your website, violates the Federal Food, Drug, and Cosmetic Act (the Act). As described in more detail below, these products are unapproved new drugs in violation of sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)] and are misbranded under sections 502 and 502(f)(1) of the Act [21 U.S.C §§ 352 and 352(f)(1)]. Your products are further misbranded under section 502(j) of the Act [21 U.S.C. § 352(j)] in that they are dangerous to health when used in the manner recommended or suggested in their labeling.
Labeling statements on your website (emphases below appear on the website) include, but are not limited to, the following:
DSMO Cream and O2xygen Force (“Package Special”)
- “The proven, all natural treatment to prevent cold sores and genital herpes outbreaks (HSV 1 and 2).”
- “Our safe method has successfully prevented herpes outbreaks ....”
- “Once you start our simple program all outbreaks cause[d] [sic] by herpes simplex 1 and 2 will immediately cease. For over 13 years our program has been effectively treating this virus- preventing all future outbreaks. No other program or product comes even close to the effectiveness of DMSO and Oxy Force (high pH therapy) in the treatment of herpes.”
- “If our procedure is followed properly all outbreaks will cease. You will remain completely outbreak and symptom free.”
- “Virtually all who order the Package Special immediately become and remain completely outbreak and symptom free. We guarantee it.”
- “Get on the fast track to immediate outbreak relief.”
- “[A] safe, all natural, effective procedure to combat (and for all practical purposes) cure both genital herpes and oral herpes.”
- “We have 100’s of testimonials from customers who claim a cure for herpes in our treatment.”
- “The herpes virus exists in cells. If cellular pH is raised to over 7.5 the herpes virus will die. This is an absolute . . . DSMO and O2xygen Force raises cellular pH (oxygen levels) sufficient to stop the herpes virus.”
O2xygen Force (oral)
- “Taking O2xygen Force as directed will keep [the herpes] virus dormant. When the virus lies dormant it poses no threat. You will become completely outbreak and symptom free and therefore not contagious.”
- “O2xygen Force has a pH of 13.7. This is what makes O2xygen Force so effective against the herpes virus.”
- If you raise cellular pH to over pH 7.5 the herpes virus cannot replicate, cannot activate with the cell. Oxy Force will gradually increase and maintain cellular pH sufficient to prevent replication of the virus.”
DMSO Cream
- “Applied properly DMSO enters the cell and immediately kills the active herpes virus. This is an indisputable fact.”
DMSO Roll-on
- “Applied properly DMSO enters the cell and kills the herpes virus. This is an indisputable fact.”
DMSO Cream w/Aloe
- “Applied properly DMSO enters the cell and kills the herpes virus. This is an indisputable fact.”
AlkaLife (oral)
- “The herpes virus thrives in an acidic environment. AlkaLife is part of the program to keep you completely outbreak and symptom free.”
These claims are supplemented by the metatags that you use to bring consumers to your website. These include “Herpes cure treatment information for std genital herpes and cold sores,” "herpes,” “genital herpes,” “herpes simplex,” “herpes medication,” “herpes treatment,” “natural cure for herpes,” “genital herpes treatment,” “natural cure for herpes symptoms,” and “herpes cure.”
Based on these claims, your products are drugs as defined by sections 201(g)(1)(B) and (C) of the Act [21 U.S.C. §§ 321(g)(1)(B) and (C)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body of man. Furthermore, these products are “new drugs,” as defined by section 201(p) of the Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for their labeled uses. Under sections 301(d) and 505(a) of the Act, a new drug may not be introduced into interstate commerce unless an FDA-approved new drug application (NDA) is in effect for it. Your sale of O2xygen Force, DMSO Cream, DMSO Roll-on, DMSO Cream w/Aloe, and AlkaLife without approved NDAs violates these provisions of the Act.
Genital herpes is not amenable to self diagnosis and treatment by individuals who are not medical practitioners. “Adequate directions for use” is defined in 21 CFR § 201.5 as “directions under which the layman can use a drug safely and for the purposes for which it is intended.” Because this condition requires the supervision of a practitioner licensed to prescribe drugs, adequate directions cannot be written for them so that a layperson can use your products safely for these uses. Thus, your products’ labeling fails to bear adequate directions for use for these indications, which causes the products to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. Because your products lack required approved applications, they are not exempt under 21 CFR §§ 201.100(c)(2) and 201.115 from the requirements of section 502(f)(1) of the Act. The introduction or delivery for introduction into interstate commerce of these products therefore violates sections 301(a) and (d) of the Act [21 U.S.C. §§ 331(a) and (d)].
The labeling for O2xygen Force, DMSO Cream, DMSO Roll-on, DMSO Cream w/Aloe, and AlkaLife includes claims for the prevention, treatment, and cure of genital herpes, as noted above. A consumer who uses these products as labeled may forgo or delay appropriate treatment, which can be dangerous not only to the consumer but also to the consumer’s sexual partners. These products are therefore dangerous to health and misbranded under section 502(j) of the Act [21 U.S.C. § 352(j)].
Genital Herpes and Cold Sores
Claims Regarding Treatment of Genital Herpes
We note that your products are offered over-the-counter (OTC) for the treatment of genital herpes. This indication is not covered by any monograph or ongoing rulemaking under the OTC Drug Review. In addition, we are not aware of any evidence that similarly formulated and labeled products were marketed on or before the inception of the OTC Drug Review, nor has FDA ever proposed that such products be included in the OTC Drug Review.
Claims Regarding Treatment of Cold Sores
OTC drug products intended for the topical treatment of fever blisters and cold sores are being evaluated under the ongoing OTC Drug Review. The Tentative Final Monograph (TFM) for this category of products was published in 1990 [External Analgesic Drug Products for Over-The-Counter Human Use; Proposed Rulemaking for Fever Blister and Cold Sore Treatment Drug Products, 55 Fed. Reg. 3370 (Jan. 31, 1990)]. However, FDA considers the use of the term “herpes” alone misleading for products marketed under the OTC Drug Review for treatment of fever blisters and cold sores, because a consumer may associate it with the genital form of herpes. 55 Fed. Reg. at 3373. As stated above, genital herpes is neither covered by any OTC monograph or ongoing rulemaking, nor is it an appropriate OTC indication.
To the extent your DMSO Cream, DMSO Roll-on, and DMSO Cream w/Aloe products are intended for indications covered by the TFM for products for the topical treatment of fever blisters and cold sores, they are also inconsistent with the OTC Drug Review for such products in other respects. For example, according to your website, the active ingredient in DSMO Cream, DSMO Cream w/Aloe, and DSMO Roll-on is dimethyl sulfoxide (DMSO). This active ingredient has not been evaluated under the OTC Drug Review for products for topical treatment of fever blisters and cold sores.
Furthermore, FDA has determined that there is a lack of adequate data to establish general recognition of the safety and effectiveness of any orally administered ingredient for OTC use to treat or relieve the symptoms or discomfort of fever blisters and cold sores. 21 CFR 310.537(a). Any OTC drug product for oral administration, including your O2xygenForce and AlkaLife products, that is labeled, represented, or promoted to treat or relieve the symptoms or discomfort of cold sores is regarded as a new drug under section 201(p) of the Act and requires an approved NDA in order to be legally marketed. 21 CFR 310.537(b). Additionally, per 21 CFR 310.537(b), any orally administered product that is labeled, represented, or promoted to treat or remove cold sores, and is not the subject of an FDA-approved application, is misbranded under section 502 of the Act [21 U.S.C. § 352].
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law, the Act and its implementing regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Furthermore, please advise this office what actions you will take to address product that you have already distributed.
Address your reply to the U.S. Food and Drug Administration; Attn: Todd Maushart, Compliance Officer, One Montvale Ave., 4th Floor, Stoneham, MA 02180. You may reach Mr. Maushart at (781)587-7486 if you have any questions about this matter.
A description of the new drug approval process can be found on FDA’s Internet website at http://www.fda.gov/cder/regulatory/applications/default.htm. Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information, Center for Drug Evaluation and Research, 10001 New Hampshire Avenue, Silver Spring, MD 20993.
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); FTC v. Nat'l Urological Group, Inc., No. 1:04-CV-3294-CAP, 2008 U.S. Dist. LEXIS 44145, at *43-44 (N.D. Ga. June 4,2008); FTC v. Natural Solution, Inc., No. CV 06-6112-JFW, 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, slip op. 18-20,2009 WL 516000 (F.T.C.), 17-19 (Dec. 24, 2009) (http://www.ftc.gov/os/adjpro/d9329/091224commissionopinion.pdf.)
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 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 Richard Cleland at 202-326-3088.
Sincerely,
/S/
Mutahar S. Shamsi
District Director
New England District Office
U.S. Food and Drug Administration
/S/
Deborah M. Autor, Esq.
Director
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
/S/
Mary K. Engle
Associate Director
Division of Advertising Practices
Federal Trade Commission
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