|Subject:||Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated|
|Issuer:||Florida District Office|
|Issued:||May 22, 2008||Closed:||
Department of Health and Human Services
Public Health Service
555 Winderley Pl., Ste. 200
VIA FEDERAL EXPRESS
May 22, 2008
713 Saco Ct.
St. Augustine, Florida 32086
Dear Ms. Sellinger:
This letter concerns your firm's marketing of C-Herb, C-4 Cream, Eye Drops, Eye/Ear Wash, Immune Max, Saw Palmetto Cream, and Wild Yam Cream on your website, www.herbtime.com. According to information on this website, 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 C-Herb products:
"Disclaimer: Consumer testimonials presented on our website are personal experiences for that individual and does [sic] not mean the same result will be achieved by others."
"Nothing herein is intended to diagnose, treat or cure any specific disease."
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(e)(3)(i).
Statements on your website that document these intended uses include, but are not limited to, the following:
• "A significant number of individuals have topically removed cancers, warts, moles and other foreign cells from various skin areas of the body. The removal success rate approaches 100%."
• "C-Herb topical data demonstrates that it consistently and regularly removes skin cancers, moles and warts."
• "Using some of the above mentioned herbs, my Mom got rid of a tumor in her left lung. [. . .] [T]he doctor detected a cancerous tumor in her left lung in February, 1993. [. . .] Well, I knew that C-Herb worked well on external moles, warts, but I hadn't used it internally up to this point. My personal friend and consultant, Wendell, told me that all my Mom needed was pycnogenol and C-Herb. Well, I muscle tested her and sure enough, all she needed was [sic] these two products. The C-Herb comes in 24 daily doses. Following only two months of treatments, she went back to the doctor and had her lung x-rayed and did a bone scan. The radiologist report was clean. They couldn't find a trace of cancer in her body."
• "When the cancer came back after the last surgery I decided to have the area treated with C-Herb. The treatment went exactly as predicted. [. . .] On about the fifth day from the first treatment, the cancer came out as a core about the size of a pencil eraser."
• "I was told by the doctors who did surgery for my colon and liver cancer that there was no hope and that I had less than 3 months to live at best. That was in 1991. I took the C-Herb and other supplements you suggested and saw amazing results within a short time, with the cancer appearing to be totally gone after several months."
• "C-Herb - Hope for HIV [. . .] In the fall of 1992, a young man who had been diagnosed with the HIV virus two years previously, wasn't getting any positive results working with his medical doctor. [. . .] In January of 1993, he was diagnosed with TB. [. . .] By June of 1993 his breathing was much improved but still tested positive for TB and his T-cell count remained very low. [. . .] He tested strong for C-Herb, pycnogenol, and yarrow TincTract. The C-Herb is an old Indian remedy for viruses and other pathogens which has historically and is currently producing fantastic results across the United States. [. . .] After only one month on the program, he went back to his doctor for further testing, and his T-cell count had gone from 100 to 212. It had more than doubled in one month's time. He also tested negative for TB. [. . .] The young man didn't tell [his doctor] that he hadn't taken any drugs for over a year, and that herbs were to be credited for the improvement. [. . .] He is still HIV positive but much stronger and possessing greater energy than he has in years. Who knows, if he continues the program, perhaps he can go from HIV positive to negative."
• "It doesn't 'pull them out' like C-herb does, but it often reduces them to a more manageable size. This formulation works with topical skin disorders that are too large to treat with C-Herb directly or for blisters like Herpes."
• "Typically C-4 cream will reduce the size of the effected [sic] area. For example, a skin cancer might be the size of a quarter or even larger before applying C-4 cream as discussed previously. After a time the area may shrink to the size of a pencil eraser with this treatment."
• "These eye-drops are a concentrated tincture made from C-Herb. They are designed for use on some types of cataracts, pink eye and other chronic eye problems."
• "The wash is a diluted tincture made from C-Herb that is very helpful in working with eye or ear infections."
• "Inhibits pathogen growth, including cancers and viruses."
• "Proven to help with shingles, arthritis, fibromyalgia, joint pain, AIDS and more"
• "Promotes tissue repair and wound healing."
Saw Palmetto Cream
• "The truth is 25% of men as young as age 20 have been found to have precancerous conditions of the prostate. This condition is known, as benign prostatic hypertrophy, or BPH. Evidence suggests that one contributing factor of BPH is elevated levels of the highly active form of testosterone known as dihydrotestosterone (DHT). Increased levels of this hormone have been found in prostatic tissue of men with BPH.
Of all the herbal preparations researched Saw Palmetto has been the most popular solution for BPH. It works by assisting in reducing the BPH by controlling or blocking the conversion of testosterone into its highly active form (5-a-reductase). Saw Palmetto also works as an anti-inflammatory herb, reducing the size of the prostate. Studies indicate that 320 mg. of Saw Palmetto per day greatly reduces painful urination, nocturia, and post-urination residue in the bladder, with significant improvement in urine, flow rate."
• "In addition to the elevated count I had a significant amount of swelling and my doctor felt that both of these were indications that I was moving quickly towards prostate cancer. [. . .] My wife spoke with an alternative practitioner who told her about Saw Palmetto Cream. I began using that faithfully and within two weeks the symptoms began to lessen."
Wild Yam Cream
• "Many have had cysts and tumors, especially in breasts, disappear after just a few weeks of using the cream. Applying wild yam cream to the skin lets the progesterone precursors that are found in the Wild Yam extract, enter the body systemically while bypassing the liver."
C-Herb, C-4 Cream, Eye Drops, Eye/Ear Wash, Immune Max, Saw Palmetto Cream, and Wild Yam Cream 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. 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. 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 the aforementioned products without approved applications violates these provisions of the Act.
Furthermore, since C-Herb, C-4 Cream, Eye Drops, Eye/Ear Wash, Immune Max, Saw Palmetto Cream, and Wild Yam Cream 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 the products 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 the aforementioned products, 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, 555 Winderley Place, Suite 200, Maitland, FL 32751, Attention: Shari H. Shambaugh, 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 (HFD-240), Center for Drug Evaluation and Research, 10903 New Hampshire Ave., W051-2201, Silver Spring, MD 20993.
Emma R. Singleton
Director, Florida District
Stephanie Newman & Karyl Sellinger
138 Palm Trail
East Palatka, FL 32131
Florida Board of Pharmacy
4052 Bald Cypress Way, Bin #C04
Tallahassee, FL 32399-3254