Department of Health and Human Services
Public Health Service
900 US Customhouse
October 5, 2005
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
Ronald G. Betz, President & CEO
Penn Herb Co, Ltd
10641 Decatur Rd
Philadelphia, PA 19154
Ref. No. PHI-06-01
Dear Dear Mr Betz:
On June 23, 2005, an investigator from the Food and Drug Administration (FDA) concluded an inspection of your herbal and dietary supplement manufacturing, repacking, and distribution facility located at 10601 Decatur Rd, Philadelphia, PA. During this inspection, you provided our investigator with labeling, including various labels and product catalogs. FDA has reviewed your labeling, including your websites at www.pennherb.com, for your products Gluco-Ease Plus™ (formerly Diab-Ease Plus™), Joint Ease™ (formerly Arth-Ease™), Prostaid Plus™, Soothing Bowel Support™ (formerly Irritable Bowel Support™), Golden Seal and Myrrh™, and Colostrum and found that they are promoted for conditions that cause them to be drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC 321(g)(1)]. The therapeutic claims on your websites establish that these products are drugs because they are intended for use in the cure, mitigation; treatment, or prevention of disease. The marketing of these products with these claims violates the Act. You can find the Act and implementing regulations on FDA's website at www.fda.gov.
Specific examples of disease claims as defined under 21 CFR 101.93(g) in your product labeling are as follows:
Gluco-Ease Plus™ (formerly Diab-Ease Plus™)
- "Diab-Ease plus is helpful for hypoglycemia, or low blood sugar."
- "Diabetes, it affects millions of people who are in a constant struggle to keep their blood sugar in a healthy state. With … Diab-Ease P1us™ … lots of people are living healthy lives … Diab-Ease-Plus™ is one place lots of people have turned to help with blood sugar concerns. This herbal blend works in harmony with your body to help promote healthy insulin levels. Here's why this proven formula should be a part of your daily health program: GYMNENA SYLVESTRE … Research indicates this herb … can help stimulate insulin production, so less sugar can be absorbed. JAMBUL SEEDS … for centuries it's been used to help reduce sugar buildup in the urine."
- "Common use: Maintains sugar balance; hypoglycemia. Works in harmony with your body to help promote healthy insulin levels."
- "Using a careful blend of select herbs, it helps maintain sugar balance and is helpful for hypoglycemia, or low blood sugar … Some of the herbs included in this blend are: Gymnema Sylvestre: … It is used in that healing tradition for lowering blood sugar levels … Jambul … is believed to lower blood sugar levels and helps reduce frequent urination that often accompanies diabetes. Huckleberry : It is also used in herbal medicine to prevent and treat diabetes. It is believed to help lower blood sugar levels because of its chromium content."
- "On a Personal Note … Our pharmacist … has been taking Diab-Ease Plus™ now for 12 years. He says, "While I take prescription medicine … I strongly believe that because I do take this blend, I am able to significantly reduce the milligram amount of my medication. I have been able to keep my glucose levels between 115-125, and occasionally, I can still eat a bowl of ice cream for dessert."
- "Why is this formula of interest to diabetics? This blend of herbs is … helpful in hypoglycemia, or low blood sugar."
- "In India, Jambul Seeds [an ingredient in the product] have … now been found to be beneficial in addressing hyperglycemia, since they reduce sugar in the urine."
- "This unique formula contains herbs … to help reduce the pain and inflammation of rheumatism."
- "Arthritis Stiffness? … Arth-Ease™ Brings Blessed Relief!"
- "Arth-Ease™ is the time proven formula of eight herbs … UVA URSA & MEADOWSWEET … these herbs have a positive effect on helping to reduce acid buildup in the body, which can lead to gout."
- "What Is Arth-Ease™? Arth-Ease™ is a synergistic blend of traditional herbs that help relieve joint and muscle stiffness, along with the pain and joint inflammation usually associated with arthritis. This soothing blend contains: Black Cohosh: used by Native Americans for reducing the pain & inflammation of arthritis. Meadowsweet: This forerunner of pharmaceutical aspirin is used in traditional herbal medicine for arthritis and other inflammatory conditions. Uva Ursi: This premier diuretic has a positive effect on rheumatism & aching joints."
- "Time Proven Relief For Arthritis Stiffness and Pain"
- "This unique formula contains … Saw Palmetto … studies show that Saw Palmetto Berries are effective in decreasing urinary frequency, especially during the night, due to inflammation of the bladder and an enlarged prostate."
- "Your prostate … normally it's about the size of a walnut, but an enlarged prostate can feel like the size of an orange, causing discomfort and "signals" to get up at night. Millions of men suffer while others have turned to Prostaid Plus'. … 90% of men with enlarged prostates felt improved comfort after six weeks of use."
- "This superior herbal formulation of 10 herbs … Some of these are: Saw Palmetto Berries: The "premier prostate herb" … is now employed as a conventional treatment for relieving some symptoms of BPH [benign prostate hyperplasia]. Nettle Leaves: Nettle is usually added to many prostate health formula (sic) for its diuretic properties. Diuretics are said to prevent excess build-up of urine in the bladder due to an enlarged prostate … Nettle is also believed to be helpful for BPH as well as bladder infections."
- "The formula contains Saw Palmetto, which has anti-inflammatory properties and reduces the size of the prostate by inhibiting the formation of dihydrotestosterone (DHT). Ninety percent of men with an enlarged prostate feel some improvement within six weeks of using Saw Palmetto."
Soothing Bowel Support™ (Irritable Bowel Support™)
- "It is helpful when affected by diarrhea, and irritable bowel and is also soothing to peptic ulcers…"
- "This soothing blend contains: CINCHONA, BIRCH & SHEPERD'S PURE, which address complaints such as diarrhea and irritable bowel syndrome. LICORICE ROOT soothes peptic ulcers…"
- "Common use: diarrhea; irritable bowel; peptic ulcers."
- "Irritable Bowel Syndrome is a painful digestive condition with varying symptoms such as diarrhea, abdominal pain and constipation."
Golden Seal & Myrrh™
- "Golden Seal has long been valued … for its antibacterial properties. It is excellent for colds and flu, inflammation and glandular swelling. … Myrrh is also beneficial for mouth and gum sores, fever blisters, and cold sores."
- "Fight Infection with Golden Seal & Myrrh."
- "Here's the potent herbal combination that's been used by herbalists for its anti-inflammatory and antibacterial properties."
- "GOLDEN SEAL. … this herb contains the active ingredient Berberine, which is believed to help promote mild antimicrobial action within the body."
- "MYRRH … is valued for its antifungal properties. Millions swear by this herb for sore throats."
- "Common use: Infections; inflammations; ulcers; mouth & gum sores, denture sores, enlarged tonsils; skin sores, wounds, and other skin irritations."
- "Fight Infections with Golden Seal & Myrrh" "An herbal 'antibiotic' combination"
- "Colostrum is rich in immunoglobulins, which have anti-bacterial and anti-viral properties; another protein, Lactoferrin, is reportedly a broad spectrum anti-viral agent."
- "Common use: helps reduce severity of infections; colds; allergies; gastrointestinal problems; promotes regeneration and accelerated healing of bone, muscle, skin, nerve tissue & cartilage…"
- "Bovine colostrums is a rich source of antibodies and infection-fighting proteins. … Colostrums [sic] essential components act as immune modulators, which can help with autoimmune diseases such as rheumatoid arthritis, fibromyalgia, and similar conditions."
Furthermore, FDA has no information that your products are safe and effective for the above referenced conditions and, therefore, these products are also new drugs under section 201(p) of the Act [21 USC 321(p)]. New drugs may not be legally marketed in the United States without prior approval from FDA as described in section 505(a) of the Act [21 USC 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. In addition, your products are misbranded under Section 502(f)(1) of the Act in that they fail to bear adequate directions for use.
This letter is not intended to be an all-inclusive review of the labeling and products your firm may market. You should review the labels for all of your products to ensure that they comply with the applicable requirements of the Act and implementing regulations. Failure to do so may result in regulatory action without further notice, such as seizure and/or injunction.
Please notify this office in writing within fifteen (15) days of receipt of this letter as to the specific actions you have taken or intend to take to correct these violations, including any steps taken with respect to product currently in the marketplace, and, an explanation of each step taken to assure that similar violations do not recur. If corrective action cannot be completed within fifteen days, please include in your reply the reason for the delay, the time within which the corrections will be completed, and any documentation necessary to indicate correction has been achieved.
Your reply should be directed to William J. Forman, Compliance Officer, at the above address.
Thomas D. Gardine
This page was posted on March 28, 2006.