Inspections, Compliance, Enforcement, and Criminal Investigations
Endurance Products Company, Inc. 06-Sep-05
Department of Health and Human Services
| Public Health Service |
Food and Drug Administration
|Seattle District |
22201 23rd Drive SE
Bothell, WA 98021-4421
September 6, 2005
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 05-30
Joseph M. Brunner, President
Endurance Products Company, Inc.
P.O. Box 230956
Tigard, OR 97281-5244
Dear Mr. Brunner:
The Food and Drug Administration (FDA) inspected your firm located at 9914 Southwest Tigard Street, Tigard, Oregon, on March 10 and June 29, 2005. During these inspections, our investigator collected labeling for your products, including literature that is included in product shipments. We reviewed your web site at www.endur.com and product literature and determined that your products ENDUR-AMIDE®", BETA-CAL-E™, ENDUR-C™, CAL-MAG COMPLEX™, ENDUR-ACIN®, EP® PLAIN NIACIN, and EP® PANTETHINE are promoted for conditions that cause the products to be drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)]. The therapeutic claims in your labeling establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. Your product EP® PHYTOSTEROL is misbranded under section 403(r)(1)(B) of the Act [21 U.S.C. 343(r)(1)(B)]. The marketing of these products with these claims violates the Act. You can find the Act and FDA's regulations through links on FDA's Internet web site at http://www.fda.gov.
Examples of some of the claims observed on your web site or promotional literature include:
Supplements for Diabetes Prevention Therapy"
" "ENDUR-Alv1IIDE® treatment resulted in prevention of IDDM [insulin-dependent diabetes mellitus] in 60 percent of the treated children."
Vitamin E has been shown to protect against heart disease, cancer of various types, and Alzheimer's disease."
In terms of coronary heart disease, it appears that vitamin E protects by preventing the oxidation of LDL cholesterol to a form that cause formation of plaque in arteries."
Vitamin E intake has been linked repeatedly with protection against a number of cancers including breast, colon, and prostate."
Vitamin C..... hastens the healing of wounds, and increases resistance to infection."
Those who routinely consume large amounts of calcium greatly reduce their risk of colon cancer."
Indeed, increased intake of these minerals [calcium and magnesium] has been shown to lower blood pressure."
Clinically proven to effectively . . . lower LDL cholesterol and reduce high triglycerides."
Benefits of Niacin . . . include . . . Reduction of blood-clot-forming fibrinogen ."
EP® PLAIN NIACIN
[EP Plain Niacin] . . . reduces levels of total and LDL cholesterol . . . ."
Research at the University of Washington combined a low dose of statin (cholesterol-lowering) drug with (P) niacin, and demonstrated the combination virtually halted the progression of CHD plaque in arteries of those with proven heart disease."
Pantethine (Pantesin) has been shown to reduce total cholesterol levels."
Pantethine has been shown to reduce total cholesterol levels in a variety of reseach [sic] subjects, both men and women, including the elderly, diabetic patients, and those with confirmed coronary artery disease.
In addition to lowering LDI...."
Furthermore, your products are not generally recognized as safe and effective for the above referenced conditions and therefore, the products are also "new drugs" under section 201(p) of the Act [2I U.S.C. 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. 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.
Your EM® Phytosterol product is misbranded under section 403(r)(1)(B) of the Act [21 U.S.C. 343(r)(1)(B)] because the labeling bears unauthorized health claims. Although these claims concern substance-disease relationships for which health claims are authorized by regulation, they do not meet the requirements of the authorizing regulation in 21 CFR 101.83. The following are examples of such claims:
EP® PHYTOSTEROLS "Excellent for lowering cholesterol" and "Regular usage taken with or just preceding meals, has been show to reduce total cholesterol levels by an average of 10 percent . . . ."
These statements are unauthorized health claims because, as written, they do not contain all of the elements required in order to make an authorized health claim for plant stero/stanol esters and risk of coronary heart disease (CHD). For example, (1) the claim on your product does not state that plant sterol/stanol esters should be consumed as part of a diet low in saturated fat and cholesterol; (2) does not state that diets that include plant sterol/stanol esters "may" or "might" reduce the risk of heart disease; or (3) does not, in specifying the disease, use the following terms: "heart disease" or "coronary heart disease". 21 CFR 101.83(c)(2)(i)(A)-(C).
This letter is not intended to be an all inclusive review of your products and labeling. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations
We request that you take prompt action to correct these violations. Failure to immediately cease distribution of your violative products could result in enforcement action by FDA without further notice. The Act provides for the seizure of illegal products, injunctions against the manufacturers and/or distributors of violative products, and criminal sanctions against persons responsible for causing violations of the Act.
Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct these violations, including any steps taken with respect to violative products currently in the marketplace, and an explanation of each step taken to ensure that violations do not recur. Your reply should be sent to the Food and Drug Administration, Attention: Lisa Althar, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421.
Charles M. Breen