Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
Pacific Region
Seattle District

 

22201 23rd Dr SE
Bothell, WA 98021-4421
Telephone: 425-488-8788
FAX: 425-483-4998

September 6, 2005
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Joseph M. Brunner, President
Endurance Products Co., Inc.
PO Box 230956
Tigard, OR 97281-5244

Ref. No. SEA-05-30

Dear Mr Brunner:

The Food and Drug Administration (FDA) inspected your firm located at 9914 SW Tigard St, Tigard, OR, 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 website 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 USC 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 USC 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 website at www.fda.gov.

Examples of some of the claims observed on your website or promotional literature include:

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 USC 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 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.

Your EM… Phytosterol product is misbranded under section 403(r)(1)(B) of the Act [21 USC 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, Attn: Lisa Althar, Compliance Officer, 22201 23rd Dr SE, Bothell, WA 98021-4421.

Sincerely,
/s/
Charles M. Breen
District Director

This page was posted on March 28, 2006.

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