Inspections, Compliance, Enforcement, and Criminal Investigations
McPhail, Richard 20-May-08
Department of Health and Human Services
Public Health Service
Atlanta District Office
May 20, 2008
RETURN RECEIPT REQUESTED
2420 North Chester Street
Gastonia, NC 28052
Dear Mr. McPhail:
This letter concerns your firm's marketing of P.D.Q.! Herbal Skin Cream and Medicardium on your websites, www.pdqherbals.com and www.behealed.biz. According to information on your websites, your products are intended to prevent, treat, or cure disease conditions or to affect the structure or function of the body.
We note that you have attempted to disclaim some of the statements on your site that indicate that the products are intended to prevent, treat, or cure disease conditions or to affect the structure or function of the body. For example, your site says regarding P.D.Q.! Herbal Skin Cream and P.D.Q.! Recovery Dietary Supplement Pill:
"No Claim is made that P.D.Q.! Herbal Skin Cream or P.D.Q.! Recovery Dietary Supplement Pill is a cure for any condition whatsoever: P.D.Q.! Herbal Skin Cream is sold as a cosmetic topical lubricant, similar to thousands of other products on the market which claim only to 'soften' skin. . . . There is no claim that P.D.Q.! Herbal Skin Cream and P.D.Q.! Recovery Dietary Supplement Pill will 'cure,' 'heal,' or 'remove' any lesion."
"Even though we believe strongly that P.D.Q.! may help you, due to the strict guidelines of the F.D.A. (Federal Drug Administration [sic]) we cannot and do not make any claims about what P.D.Q.! Herbal Skin Cream or P.D.Q.! Recovery Dietary Supplement can do for you."
However, untrue or misleading information in one part of your site will not be mitigated by inclusion of such a"disclaimer." Cf. 21 C.F.R.202.1(eX3)(i).
Statements on your website, www.behealed.biz, that document these intended uses include, but are not limited to, the following:
P.D.Q! Herbal Skin Cream
• "P.D.Q.! will not harm normal tissue. Only abnormal tissue is affected by the softening, allowing the body's immune system to attack, destroy and remove the dangerous lesions to which P.D.Q.! Herbal Skin Cream is applied."
• "Guaranteed! Yes, 100% full satisfaction or your money back. We are careful not to claim a "cure" (and we don't use the word "cancer" to describe our product in any way.) We want to abide by the rules and regulations of the F.D.A., thus we sell P.D.Q.! as a cosmetic only."
Medicardium (Magnesium Di-Potassium EDTA)
• "Mercury accumulates in the brain, heart, kidneys and endocrine glands and can cause depression, auto-immune diseases, memory loss, tremors, anemia and heart attack. EDTA has been scientifically proven to bind to and remove Mercury from the body."
• "Aluminum . . . It accumulates in the skin, bones, brain and kidneys and can cause Alzheimer's and Parkinsons [sic] disease. EDTA has been scientifically proven to bind to and remove Aluminum from the body."
• "Nickel . . . It accumulates in the bones, kidneys, liver, lungs, immune system and the brain, where it can cause genetic damage and cancer. EDTA has been scientifically proven to bind to and remove Nickel from the body."
Statements on your website, www.pdgherbals.com, that document these intended uses include, but are not limited to, the following:
P.D.Q.! Herbal Skin Cream
• "With P.D.Q.! the entire area can be treated. (In only ten days, the area of the skin shown above was completely back to normal.)"
• "Or, maybe your doctor has diagnosed the lesion as skin cancer (basal cell, squamous cell, melanoma, actinic keratosis). While no claims are made by the distributor, a dose of P.D.Q.! Herbal Skin Cream may be effective in aiding the body's immune system to dissolve the skin lesion as it has for over 3000 users and me and members of my family (considerably more than 10,000 lesions overall, with NO FAILURES!)."
• "I want to tell you how P.D.Q.! worked on us: It was fast! All of us had a reaction on skin lesions (some of which had been biopsied by the medical profession and had been diagnosed as either basal cell carcinoma, squamous cell carcinoma, actinic keratosis, and even melanoma). Results appeared within 24 hours."
• "It is a miracle of a product. I hope you can keep marketing this product as it is a life saver for anyone who has skin cancer and does not want to have radiotherapy or surgery followed by skin grafting."
• "I bought the product because I was tired of going under the knife having over 12 cancerous lesions removed. I was very skeptical but I am here to tell you the product works as advertised."
P.D.Q.! Herbal Skin Cream and Medicardium are drugs, as defined by section 201 (g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals and intended to affect the structure or function of the body of man or other animals. Moreover, 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. We note your claim that P.D.Q.! Herbal Skin Cream is generally recognized as safe. Our regulations regarding the conditions under which over the counter drugs are generally recognized as safe and effective and not misbranded are found at 21 CFR part 330. Under sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of P.D.Q.! Herbal Skin Cream and Medicardium without approved applications violates these provisions of the Act.
Furthermore, since P.D.Q.! Herbal Skin Cream and Medicardium are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use them safely for their intended uses. Thus, your products' labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1).
The issues and 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 and FDA regulations. We advise you to review your websites, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.
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. If you no longer manufacture or market P.D.Q.! Herbal Skin Cream and Medicardium, your response should so indicate, including the reasons that, and the date on which, you ceased production. Additionally, if another firm manufactures the products identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the products is not the manufacturer, please include the name of your supplier in addition to the manufacturer.
Please direct your response to the U.S. Food and Drug Administration, 60 Eighth St. NE, Atlanta, GA 30309, Attention: Serene N. Ackall, Compliance Officer.
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, 10903 New Hampshire Avenue, W051-2201, Silver Spring, MD 20993.
Mary H. Woleske
Atlanta District Director
P.O. Box 250
Gastonia, NC 28053
North Carolina Board of Pharmacy
Jack W. "Jay" Campbell IV
P.O. Box 4560
Chapel Hill, NC 27515-4560