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

Public Health Service
Food and Drug Administration
  Southwest Region
Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
Telephone: 303-236-3000
FAX: 303-236-3100<

January 06, 2009

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Ms. Jenine M. Cohoon
True Renewal
4618 Windsor Dr.
Provo, UT 84604

3214 N. University Ave. #223
Provo, UT 84604.

DEN-09-04-CIWL

WARNING LETTER

Dear Ms. Cohoon,

This is to advise you that the Food and Drug Administration (FDA) has reviewed your websites at the Internet addresses www.truerenewal.com, www.healthwithmms.com, www.drjenine.com, and www.oxypowdercleanse.com and has determined that the products "Miracle Mineral Supplement," "Dr Ohhira Essential Formulas Probiotics 12 Plus Original Formula," "Graviola," "Graviola Max," and "Livatrex" 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)(B)]. The therapeutic claims on your website 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 websites include:

Miracle Mineral Supplement (www.healthwithmms.com)

Dr. Ohhira's Essential Formulas Probiotics 12 Plus Original Formula (www.healthwithmms.com)

Miracle Mineral Supplement (www.truerenewal.com)

Graviola (www.truerenewal.com and www.drjenine.com)

Graviola Max (www.truerenewal and www.drjenine.com)

Livatrex (www.oxypowdercleanse.com)

These claims are supplemented by the metatags used to bring consumers to your websites through Internet searches. The metatags include:

The unlawful disease treatment and prevention claims observed for these and other products on your websites are too numerous to mention 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.

Your products are not generally recognized as safe and effective for the above referenced uses and therefore, the products are also "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 "Miracle Mineral Supplement," "Graviola," "Graviola Max," "Dr Ohhira Essential Formulas Probiotics 12 Plus Original Formula" and "Livatrex" are also misbranded within the meaning of section 502(f)(1) of the Act in that labeling for these drugs fail to bear adequate directions for use [21 U.S.C. § 352(f)(1)]

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 for causing violations of the Act [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 Nancy G. Schmidt, Compliance Officer, Denver District at the address noted above.

Sincerely,

/S/

H. Thomas Warwick,
District Director, Denver

This page was posted on January 31, 2010.

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