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

Public Health Service
Food and Drug Administration


 

New England District
One Montvale Avenue
Stoneham, Massachusetts 02180
(781) 596-7700
FAX: (781) 596-7896

WARNING LETTER

NWE-17-08W

VIA FEDERAL EXPRESS

August 15, 2008

Mr. James J Feijo
Daniel Chapter One Inc
2749 East Main Road
Portsmouth, RI 02871

1028 East Main Road
Portsmouth, RI 02871

P.O. Box 223
Portsmouth, RI 02871

Dear Mr. Feijo:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your websites at the Internet addresses www.danielchapterone.com, dc1pages.com, and dc1store.com and has determined that the products "7 Herb TM Formula," "Apple Pectin Plus," and "CoQ10" are promoted for conditions that cause the products to be drugs under section 201 (g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321 (g)(1)(13)). The therapeutic claims on your websites establish that the 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.

Examples of some of the claims observed on your web sites include:

7 Herb™ Formula

In description of ingredients:

Examples of claims in the form of testimonials include:

Apple Pectin Plus

CoQ10

Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are "new drugs" under section 201(p) of the Act [21 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 products "7 HerbTM Formula," "Apple Pectin Plus," and "CoQ10" are also misbranded within the meaning of section 502(f)(1) of the Act in that labeling for these drugs fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)).

The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. While reviewing your websites, we noticed that you were promoting the products listed above for the treatment and/or prevention of diseases other than cancer. Additionally, while reviewing these websites and other websites that you operate, including www.alimentz.com, www.gdu2000.com, www.microcalplus.com, and www.sero5.com, we noticed that you were promoting other products for disease treatment and/or prevention. The, unlawful disease treatment and prevention claims on your websites were too numerous to list in this letter. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing 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 described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 §§ U.S.C. 332 and 334].

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 the violations noted above and to assure that similar violations do not occur. Include any documentation necessary to show that correction has been achieved. 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 response should be directed to Bruce R. Ota, Compliance Officer at the above address.

Sincerely,

/S/

John R. Marzilli
Acting District Director
New England District

This page was posted on January 14, 2009.

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