Inspections, Compliance, Enforcement, and Criminal Investigations
The Old Path Natural Herbs Inc 22-Sep-05
Department of Health and Human Services
| Public Health Service |
Food and Drug Administration
|555 Winderley PI., Ste. 200 |
Maitland, FL 32751
RETURN RECEIPT REQUESTED
September 22, 2005
Sylvester Jones, President and Owner
The Old Path Natural Herbs Inc.
55 Brent Lane
Pensacola, FL 32503
Dear Mr. Jones:
The Food and Drug Administration (FDA) conducted an inspection at your facility at the above address on March 21 through 25, 2005. During that inspection, the investigator collected labeling associated with your products, God's Herbal Blessing Tea, Eye Food, and Natural Herb Food for Obesity. In addition, we reviewed labeling on your website, http://www.oldpath.com. This review shows serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) in the labeling of your products. You can find the Act and FDA's regulations through links on FDA's Internet home page, http://www.fda.gov.
Under the Act, articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man are drugs [section 201(g)(1)(B) of the Act, 21 U.S.C. 321(g)(1)(B)]. The labeling for your God's Herbal Blessing Tea, Natural Herb Tea, Natural Herbal Food for Obesity, Natural Herb Tea Laxative and Eye Food products on your website and in the literature packet provided to potential and actual customers bear the following claims:
God's Herbal Blessing Tea
The literature packet and website provide a list of names, phone numbers, and serious diseases or ailments and implying that your products are useful for the treatment or prevention of serious diseases, including but not limited to, emphysema, thyroid and breast cancer, AIDS, diabetes, prostate cancer, lung cancer, brain tumor and kidney stones.
The literature packet and website include a list of 183 serious diseases or medical conditions implying that your products are useful for the treatment or prevention of serious diseases, including but not limited to, pneumonia, diabetes, AIDS, sickle cell anemia, lupus, cancer and tumors anywhere in the body including breast cancer, colon cancer, and skin cancer, glaucoma, hepatitis B, Crohn's disease, leukemia, venereal disease, hepatitis C, cirrhosis of the liver, multiple sclerosis, and lymphoma.
o " . . .[T]heir son . . . was stricken with AIDS . . . .He had pneumosystic pneumonia . . . . Minister Jones instructed the parents to have the nurses to (sic) pour 5 cups of his tea every day into their son's feeder tube . . . . Today . . .he does not have a trace of the AIDS virus in his system."
o "Thousands of individuals have used the tea and he [Minister Jones] says that he has not encountered and (sic) condition that the tea was not able to treat. He has successfully treated diabetes, emphysema, hypertension, heart conditions and over 135 other medical conditions."
o "He has also successfully treated cancer patients at the brink of death such as, [redacted] of Pensacola, Florida, a woman who was diagnosed with breast cancer who went home to die. She was also diagnosed with blood clots, silicone poisoning and as a borderline diabetic. When she took the tea, the cancer and all the other conditions were completely eliminated."
o "A local minister in Atlanta observed the tea improve his wife's condition form (sic) a stroke within 24 hours of taking it."
o "He [Minster Jones] has also treated and cleared up colon cancer, tumors, impotence, glaucoma, genital herpes, arthritis and other numerous ailments."
Your literature packet: and website also include claims in the form of numerous testimonials. Some examples are as follows:
" . . .[T]here was a lump in my right breast the size of a golf ball . . . . I purchased two gallons of tea and called Minister Jones who reassured me that if I drank five eight-ounce cups of tea a day, my lump would soon dissolve. . . .The lump was totally dissolved in seven days. . . .[I]n addition to dissolving the lump in my breast, and freeing me from breast cancer. . . the tea healed me of gum disease, bleeding gums, female depression, hearing impairment . . . and healed scars sustained in an accident from 1993."
"The owner of the [redacted] shop told me if I drink the tea . . . in 3 months all the tumors on my lung would be gone . . . . I went back to the doctor . . .and all the tumors are gone."
"In 1984, I had Arthritis and Bursitis . . . .I suffered with High Blood Pressure and a Nerve- condition. In the same year, I was diagnosed with Malignant Breast Cancer. The doctor removed the cancer, but there was a chance the cancer would return. That is when I started taking the Herbal Tea NINE YEARS AGO. In the nine years I have been taking the tea. (sic) I have not been bothered with any of the illnesses listed above."
Natural Herb Tea - External Use
Your literature packet and website include claims in the form of testimonials. An example is as follows:
Pastor Jones . . .[also] gave me a quart of external tea to wash my leg with twice a day. After drinking and washing, my gangrene began to dry up and heal. After a, year, the miracle began to happen. Today, I am healed . . . ."
Natural Herbal Food For Obesity
The name of the product is a disease claim, in that it implies that the product is intended for use in the treatment of obesity.
Natural Herb Tea Laxative
The name of the product is a disease claim, in that it implies that the product is intended for use in the treatment of constipation, and there is no qualifying language to indicate that the product is only intended to treat occasional constipation, or as an aid to maintain regularity, and is not intended to be used for chronic constipation, which may be a symptom of a serious disease.
Because these products are not generally recognized as safe and effective when used as labeled, they are also "new drugs" as defined in section 201(p) of the Act [21 U.S C. 321(p)]. Under section 505 of the Act [21 U.S.C. 355(a)], a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA). FDA approves anew drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Promotional materials for Eye Food, showing intended use of "The Old Path" Natural Herb Tea to treat the pressure and pain associated with glaucoma, cause this product to be a drug. Examples of such claims include the following:
Video infomercial labeled as "The Old Path" Natural Herbs BLAB TV 1-16-05 from your television promotion: It includes a testimonial of a consumer of the tea who was born blind and had a history of glaucoma. The video implied that your herb eye wash tea treated and reduced the pressure and pain associated with his glaucoma.
Video entitled "The Old Path" God's Herbal Tea: It includes a testimonial implying that your eye tea product treated or alleviated symptoms of the "rare eye disease" toxoxoplasmosis, and saved the consumer's eyesight.
Eye Food Analysis
In addition, during our inspection we collected a sample of your "Eye Food" product, promoted as a drug, intended to be a multi-use preparation to be applied directly into the eyes. Your Eye Food finished product was analyzed and failed sterility testing. All preparations intended for ophthalmic use should be sterile in accordance with 21 CFR 200.50. Therefore, your Eye Food product is adulterated within the meaning of section 501(c) of the Act [21 USC 351(c)]. Since your product is promoted for deficiencies in the eye and problems such as glaucoma, cataracts, floaters, toxoplasmosis, and degenerative eye cells, this product is also misbranded within the meaning of section 502(j) of the Act [21 USC 352(j)] since it is dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended or suggested in the labeling thereof.
In addition, the God's Blessing Herbal Tea, Eye Food, Natural Herb Tea-External Use, and Natural Herbal Food for Obesity are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] because their labeling fails to bear adequate directions for use for the conditions for which they are offered.
This letter is not intended to be an all-inclusive review of your web site, products, labeling and promotional materials, but merely represents the types of claims found in your product labeling. It is your responsibility to ensure that all of your products comply with the Act and its implementing regulations.
Failure to promptly correct these violations may result in enforcement action without further notice. Enforcement action may include seizure of violative products, injunction against the manufacturers and distributors of violative products, and criminal sanctions against persons responsible for causing violations of the Act.
If you choose to revise your labeling so as to position your products as conventional foods, you must comply with the legal requirements governing conventional food products. FDA issued a letter regarding the uses of botanical and other novel ingredients in conventional foods, which you can find on FDA's website at: http://www.cfsan.fda.gov/-dms/ds-Itr15.html.
Please advise this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken or will be taking to correct these violations, including the steps taken to assure that similar violations do not re-occur. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed. Your reply should be addressed to Shari H. Shambaugh, Compliance Officer, U .S. Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751.
Emma R. Singleton
Director, Florida District