| Public Health Service Food and Drug Administration |
| Los Angeles District Office 19701 Fairchild Irvine, CA 92612 Telephone: (949) 608-2900 |
Department of Health and Human Services
April 28, 2011
WARNING LETTER
Pacific Naturals
2049 North Lincoln Street
Burbank, CA 91504
WL 37-11
350 N Glenoaks Blvd., Suite 304
Burbank, CA 91502
To Whom It May Concern:
This letter is to advise you that the United States Food and Drug Administration (FDA) has reviewed your websites at the Internet addresses www.herpeset.com, www.wartrol.com, www.pacificnaturals.com, and www.healthbuy.com. The FDA has determined your firm’s marketing of the products Herpeset and Wartrol, 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 misbranded under sections 503 and 301 of the Act [21 U.S.C. §§ 353 and 331]. Herpeset is further misbranded under section 502(j) of the Act in that it is dangerous to health when used in the manner recommended or suggested in its labeling.
Labeling statements on your website include, but are not limited to, the following:
Herpeset
- “Genital Herpes Relief by Herpeset”
- “Now you can get natural homeopathic relief from the painful symptoms of herpes eruptions with Herpeset, a very special homeopathic blend of 9 ingredients, each known . . . to safely reduce the discomfort caused by symptoms of Herpes Simplex Virus”
- “Homeopathic doctors have been using the separate ingredients in Herpeset™ to treat single symptoms of oral and genital herpes for decades, but our experts in homeopathy have chosen a blend of these natural ingredients to help relieve a wider variety of symptoms in one, easy-to-use spray application.”
- “Every ingredient was chosen for this unique formula to both alleviate discomfort and help relieve multiple symptoms associated with herpes simplex viral outbreaks.”
- “Relieves symptoms associated with the herpes simplex virus: oral eruptions, swelling, skin eruptions, and discomfort.”
- “Genital Herpes Relief”
- “Herpeset Natural homeopathic relief from the painful symptoms of herpes eruptions.”
Wartrol
- “Wartrol Genital Wart Relief”
- “With Wartrol Homeopathic Genital Wart Relief, you’ll be able to get relief from Genital Warts symptoms without a prescription.”
- “Wartrol Homeopathic Genital Wart Relief is a proprietary formula of natural ingredients chosen for their traditional use in homeopathic medicine treating many of the symptoms associated with Genital Warts.”
- “Just two sprays three times a day get these ingredients into your bloodstream where they can effectively fight the unpleasant symptoms of Genital Warts and help you finally get some relief.”
- “Genital Wart Relief”
- “Helps reduce appearance and discomfort of warts on any area of the body.”
- “With Wartrol Genital Warts Relief formula, you can get relief from the embarrassing and aggravating symptoms of genital warts.”
- “Homeopathic Genital Wart Relief, you’ll be able to get relief from Genital Warts symptoms without a prescription.”
Based on these claims, your products are drugs as defined by section 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.
Section 503(b)(1) of the Act [21 U.S.C. 353(b)(1)] identifies criteria for determining the prescription status of a product. The products listed above are prescription drugs within the meaning of section 503(b)(1) of the Act because they are intended to treat diseases that require diagnosis and treatment by a physician or are intended to provide treatment for symptoms usually caused by an underlying disease process that requires diagnosis and treatment by a physician.
Because they may be dispensed only by prescription of a licensed practitioner, these products are misbranded under section 503(b)(4) of the Act [21 U.S.C. § 353(b)(4)] in that their labels fail to bear the symbol, "Rx only."[1] Your marketing of these misbranded products violates sections 301(a) and (k) of the Act [21 U.S.C. §§ 331(a) and (k)].
These products are labeled as homeopathic drugs and have active ingredients measured in homeopathic strengths.[2] The definition of "drug" in section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)] includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drugs are subject to the same regulatory requirements as other drugs; nothing in the Act exempts homeopathic drugs from any of the requirements related to adulteration, labeling, misbranding, or approval. Many homeopathic drugs are manufactured and distributed without FDA approval under enforcement policies set out in the Agency's Compliance Policy Guide entitled, "Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15)" (the CPG). As its title suggests, the CPG identifies specific conditions under which homeopathic drugs may ordinarily be marketed; thus, in order to fall under the enforcement policies set forth in the CPG, a homeopathic product must meet the conditions set forth in the CPG. One of those conditions is compliance with section 503(b) of the Act. Under the CPG, only homeopathic products intended solely for self-limiting disease conditions amenable to self-diagnosis (of symptoms) and treatment may be marketed OTC. Homeopathic products offered for conditions not amenable to OTC use must be marketed as prescription products.[3]
Moreover, the labeling for Herpeset includes claims for the prevention, treatment, and cure of genital herpes, as noted above. A consumer who uses this product as labeled may forgo or delay consultation with a licensed practitioner and treatment as suggested by such licensed practitioner, which can be dangerous not only to the consumer but also to the consumer’s sexual partners. Herpeset is therefore dangerous to health and misbranded under section 502(j) of the Act [21 U.S.C. § 352(j)].
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your product. 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: Mariza Jafary, Compliance Officer, 19701 Fairchild, Irvine, CA 92612. You may reach Ms. Jafary at (949) 608-2977 if you have any questions about this matter.
Sincerely,
/S/
Alonza Cruse
District Director
Los Angeles 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
[1] The Agency's guidance, "Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15)," states that, in accordance with § 503(b)(1) of the Act, homeopathic drug products offered for conditions that require diagnosis or treatment by a licensed practitioner must bear the prescription legend, "Caution: Federal law prohibits dispensing without prescription." This guidance was issued by the agency in 1988. In 1997, Congress enacted the Food and Drug Administration Modernization Act (FDAMA); section 126 of FDAMA amended § 503(b)(4) of the Act to require that the label of a prescription drug must bear the symbol "Rx only."
[2] For example, the label for Herpeset includes the ingredients Apis mel 3X, Arsenicum alb 200C, Baptisia 3X, Capsicum 6X, Dulcamara 30C, Echinacea ang 3X, Nitricum ac 200C, Pyrogenium 200C, and Rhus tox 200C.
[3] We note that the CPG also states that, if the HPUS specifies a distinction between nonprescription (OTC) and prescription status of a product based on strength (e.g., 30X), and that distinction is more restrictive than section 503(b) of the Act, the more stringent criteria (i.e., the HPUS criteria) will apply. It follows from this that, if the HPUS specifies a distinction between OTC and prescription status based on strength, and that distinction is less restrictive than section 503(b) of the Act, the section 503(b) criteria will apply regardless of the HPUS distinction.
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