Inspections, Compliance, Enforcement, and Criminal Investigations
Department of Health and Human Services
Public Health Service
March 4, 2008
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 08-10
Joe Glickman, M.D.
P.O. Box 1613
Whitefish, Montana 59937
Dear Dr. Glickman:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address http://www.health-science-report.com. Based on promotional claims made on your website, your products Beta-mannan and Micronutrient are 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)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease in humans. Examples of some of the claims on your websites include:
• “Through intensive research, Dr. Joe Glickman, Jr., M.D. has created an all-natural, holistic, Aloe vera-based supplement called Beta-mannan™. Since its development in 1996, Beta-mannan™ has safely eliminated HPV-related illnesses in only 90 days in the vast majority of cases for thousands of men and women who have followed the treatment recommendations with Beta-mannan™.”
• “Beta-mannan™ is an effective treatment for HPV. Beta-mannan™ eliminates the HPV manifestations in most cases and is more effective than traditional surgical or medical treatments.”
• “Since Beta-mannan™ appears to eliminate cervical dysplasia and genital warts in most cases, I do not consider HPV to be nearly as serious now as it was in the past. Aside from the problems of cervical dysplasia and genital warts (which can be treated successfully with Beta-mannan™), there are few other common problems caused by HPV.”
• “Beta-mannan™ may work either by . . . killing virus directly, or (4) by somehow exposing the virus to the cellular immune system T-cells (possibly by killing infected cells).”
• “Therefore, if HPV infection is present, it would be very worthwhile to eliminate it with Beta-mannan™ in order to decrease the risk of miscarriage.”
• “There is good evidence that vulvar vestibulitis syndrome (VVS) can be caused by HPV. Vulvar vestibulitis, a type of vulvodynia, affects many women. Patients typically present with a history of intermittent or continuous, localized, vulvar pain and frequently cannot tolerate sexual intercourse . . . Therefore, the HPV factor in VVS could be even more significant than suggested in this study. In all cases of VVS, it would be worthwhile to try Beta-mannan™.”
• “Dr. Glickman: I just wanted to let you know that my August 17, 2002 pap smear results are NORMAL!!!!! I thought I would never hear those words again. Two in a row to be precise!!!!! Now I can truly consider getting pregnant without any worries! I have had such a horrible time since my first abnormal pap test some four years ago.”
• “Dr. Glickman, Cured! Just a quick note to let you know that it worked. I was diagnosed with moderately severe cervical dysplasia. My first doctor was a bit scalpel happy, so I got a second opinion. My new doctor had little hope that the Beta-mannan would work, but said it would be ok to put off picking a procedure for a few months and try your treatment. Four months later, my pap came back perfectly normal. Of course I have to go back in every three months for a year, but you cannot imagine how relieved I am. Everyone in my family was skeptical, but not any more. Thank you very much.”
• “Dear Dr. Glickman, Three months ago my doctor wanted to give me a hysterectomy, I refused because my friend told me about Beta-mannan. I already had a conization. He said I was beyond dysplasia and it was way in my cervical canal, and he didn't get it all and my best bet was a hysterectomy. Anyway, I ordered your Beta-mannan and three months later I got the best pap I had in years.”
• “I just ordered my maintenance supply of Beta-mannan! In October 2002 I was diagnosed with cervical dysplasia CIN II. They told me that I needed surgical treatment and I got really scared. After six months of searching for some alternative therapies I was lucky to find Dr. Glickman’s site. I decided to give it a try! I started with Beta–mannan in May 2003 and as of December 2003 I had two PAP smears completely normal. I do not have the right words to express my gratitude!”
• “Micronutrient™ is a nutritional food supplement and contains a very specific combination of herbs and extracts designed to help decrease the number of outbreaks of herpes. It is completely natural.”
• “The use of Beta-mannan™ and Micronutrient™ may decrease the length of a herpes outbreak. If both supplements are taken for the purpose of preventative maintenance, the incidence of herpes outbreaks should be decreased significantly.”
The claims are supplemented by the metatags that you use to bring consumers to your websites. The metatags include “HPV,” “cervical dysplasia,” “genital warts,” and “herpes.”
Beta-mannan and Micronutrient 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 humans. Namely, Beta-mannan and Micronutrient are promoted as intending to cure, mitigate, treat, or prevent herpes, cervical cancer, cervical dysplasia, vulvar vestibulitis syndrome, and other diseases. Moreover, because the products are not generally recognized as safe and effective when used under the conditions prescribed, recommended, or suggested in their labeling, they are also new drugs as defined in section 201(p) of the Act. 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 Beta-mannan and Micronutrient without an approved application violates these provisions of the Act.
On your website, you claim that your products are dietary supplements. A dietary supplement may not bear claims that it prevents or treats a disease, except for authorized health claims about reducing the risk of a disease. Other disease prevention and treatment claims render the product a drug subject to the drug requirements of the Act. Your products make disease prevention and treatment claims that are not authorized health claims; accordingly they qualify as drugs under the Act.
Furthermore, because these products 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, Beta-mannan’s and Micronutrient’s 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.
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 Beta-mannan and Micronutrient, 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 send your reply to the Food and Drug Administration, Attention: Lisa M. Althar, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421.
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 (HFD 240), Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, Maryland 20857.
Charles M. Breen
cc: Jeannie Worsech, Executive Director
Montana Board of Medical Examiners
301 South Park, 4th Floor
P.O. Box 200513
Helena, Montana 59620-0513
Montana Board of Pharmacy
PO Box 200513
301 S Park Ave, 4th Floor
Helena, Montana 59620-0513