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

Public Health Service
Food and Drug Administration

 

Los Angeles District
19701 Fairchild
Irvine, CA 92612-2506 Telephone: 949-608-2900

January 25, 2005
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

John R. Rose, Chairman & CEO
Life-Flo Health Care Products
Nutraceutical Labs, Inc. 11202 N. 24th Ave Phoenix, AZ 85029-4745

Ref. No. W/L 07-05

Dear Mr Rose:

This letter refers to your firm's marketing and distribution of the products "life-flo Progesta Care," "life-flo Andro-Edge Superior Androstenedione Stack," "AllVia Progensa 10," "AllVia Progensa 20," "AllVia Progensa 20 PLUS," and "AllVia AndroEdge." An inspection of your firm, by the Food and Drug Administration Phoenix Resident Post, Los Angeles District conducted June 10-17, 2004, documented that you market these products for the treatment, cure, mitigation or prevention of disease. The inspection also revealed violations of current good manufacturing practice (CGMP) regulations.

The following list contains examples of claims for these products as they appear on the product labels, in the product sales catalog and on your websites, www.life-flo.com, www.buylife-flo.com, and www.allviahealth.com, where they are offered for sale. All of the products cited in this letter are topically applied hormone creams.

  1. Life-flo Brand products

    1. Progesta-Care

      Label

      "life-flo for women Progesta-Care Natural Progesterone PMS and Menopause Solutions … contains natural, bio-identical progesterone …"

      Website

      "ProgestaCare is the #1 selling natural progesterone cream trusted by millions of women worldwide."

      "…helps women reduce the severity of PMS symptoms, lessen the efsects of menopause and counter-balance the effects of estrogen dominance."

      "…recommended by physicians … utilizes USP grade micronized natural progesterone derived from wild yam … contains an average of 480mg of natural progesterone per ounce."

      "…HEALTH CONDITIONS ADDRESSED BY THIS PRODUCT: PMS Irregular Bleeding Menopause Infertility Fibroids Cyclical Headaches"

      "Customer Care - FAQ."

      "Recent studies have discovered that transdermal delivery (ie: absorbed through the skin) of many supplements — such as progesterone, can achieve a higher absorption rate than ordinary methods. … When supplements are delivered transdermally, they go directly to the bloodstream — initially bypassing the liver — allowing as much as 90% of the supplements to reach the cells where they are needed. … How can men benefit from using progesterone? … Supplemental progesterone aids in the treatment of health concerns such as osteoporosis and prostatitis. … twenty percent of those affected by osteoporosis are men. Many studies have shown that progesterone treatment helps replace the bone density that has been lost due to osteoporosis. Benign prostatic hypertrophy (BPH) … Progesterone treatment has been shown to shrink the prostate, alleviating the painful symptoms of BPH … it has extremely effective absorption qualities. … in a woman's body … Progesterone … is promoting bone building, thus reducing the risk of osteoporosis. It also helps keep blood sugar levels and protects against endometrial cancer and breast cancer."

      Catalog

      "Life-flo has developed a group of all natural products specifically designed f or women. … address hormone imbalance, vaginal dryness, libido, PMS and menopause … More women are seeking natural alternatives to Synthetic Hormone Replacement Therapy (HRT) … HRT is associated with the following health risks: … breast cancer … stroke … ovarian cancer rates … dementia

      "Women's Health Initiative Findings"
    2. Andro-Edge™

      Label

      "life-flo … Andro-Edge Superior Androstenedione Stack with Estro-Block™ … Promotes natural testosterone production and helps increase libido and muscle mass"

      "Physicians 1st Choice"

      "…25mg. of natural Androstenedione"

      Website

      "AndroEdge … includes ingredients that don't allow the andro to convert to estrogen, … Androstenedione is a steroid hormone … HEALTH CONDITIONS ADDRESSED BY THIS PRODUCT: Muscle Mass/Tone Athletic Performance Libido Male Sexual Characteristics … Each full press of the pump dispenses the doctor recommended 2.5 mg. of natural androstenedione (an average physiological amount recommended for men by many medical researchers.)"
  2. AllVia Brand products

    1. Progensa 10

      Label

      "All Via Progensa 10 Natural Progesterone Cream"

      Website

      "Progensa 10 M — For Men Superior Natural Progesterone Cream, 3 oz. Commonly recommended by medical professionals for: … > Prostate Problems > Regulate Cell Apoptosis … 10mg of natural progesterone. Progensa 10 contains an average 240mg per ounce of Natural Progesterone USP grade. "

      "… has extremely effective absorption qualities. "

      "… PLACE ORDER"

      Catalog

      "Progensa 10 for Men • Hormone Precursor • Prostate Disease "
    2. Progensa 20

      Label

      "AllVia Progensa 20 Natural Progesterone Cream"

      Website

      "Progensa 20™ — For Women Superior Natural Progesterone Cream, 3 oz. Commonly recommended by medical professionals for:
      • PMS
      • Irregular Bleeding
      • Fibroids
      • Menopause
      • Infertility
      • Headaches"

      "Measured Dosage Pump dispenses the doctor-recommended 20 mg of natural progesterone … 480mg per ounce of Natural Progesterone USP grade. "

      "… has extremely effective absorption qualities."

      "PLACE ORDER"

      Catalog

      "Progensa 20 for Women Natural Progesterone Cream …
      • PMS
      • Irregular Bleeding
      • Cyclical Headaches
      • Menopausal Symptoms
      • Hot Flashes
      • Weight Gain
      • Infertility"
    3. Progensa 20 PLUS

      Catalog

      "Progensa 20 PLUS for Women"

      "Natural Progesterone cream. Also contains MSM, Burdock Root, … Dispenses 20 mg of Natural Progesterone with each pump.
      • PMS I Menopausal Symptoms
      • Decreased Libido
      • Mood Swings
      • Sleep Disorders
      • Osteoporosis"
    4. Androedge 25

      Label (as noted on the AllVia website)

      "AllVia ANDROEDGE 25 Natural Androstenedione…"

      Website

      "ANDROEDGE 25™ Superior Natural Androstenedione Cream, 2 oz. Commonly recommended by medical professionals for: > Poor Libido > Fatigue > Low Testosterone > Decreased Muscle Mass … plays a vital role in accelerating tissue growth and tissue repair."

      "… In Women, … The benefits of a carefully regulated, low-level program can be increased bone density (to help reverse the effects of osteoporosis)"

      "PLACE ORDER"

      Catalog

      "ANDROEDGE 25 Natural Androstenedione Cream. Dispenses 20 mg with each pump.
      • Decreased Muscle Mass & Muscle Tone
      • Decreased Bone Density
      • Low Energy a Reduced Sex Drive
      • Suboptimal Athletic Performance"

The products "life-flo Progesta Care," "life-flo Andro-Edge Superior Androstenedione Stack," "AIlVia Progensa 10," "AllVia Progensa 20," "AllVia Progensa 20 PLUS," and "AllVia AndroEdge" are "drugs," as defined by the Federal Food, Drug and Cosmetic Act (Act), 201(g), because they are intended to cure, mitigate, treat or prevent disease. Moreover, these products are "new drugs," as defined by §201(p) of the Act, because there is no evidence that they are generally recognized as safe and effective for their intended uses.

The products listed above are subject to a final regulation codified in Title 21 Code of Federal Regulation (21 CFR) Part 310.530, Over-The-Counter (OTC) Topically applied hormone drug products. This regulation states that any over-the-counter drug product that is labeled, represented, or promoted as a topically applied hormone-containing product for drug use, other than hydrocortisone, … is regarded as a new drug.

"Progesterone" and "Androstenedione" appear on the labels of your products and constitute an implied therapeutic or physiological effect on the body in addition to the claims that appear in the product labeling.

These products are not the subject of an approved new drug application, and their marketing in the United States violates §505(a) of the Act. Under §505(a) of the Act, a "new drug" may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for such drug.

Further, the Act defines the term, "dietary supplement" in §201(ff)(2)(A)(i) to mean a product that is "[I]ntended for ingestion … " Topical products cannot be dietary supplements because they are not intended for ingestion, but rather bypass the alimentary canal by direct absorption through the skin. Consequently, a product that is not intended for ingestion cannot meet the definition of a "dietary supplement." Further, all transdermal drug delivery products are new drugs because of the newness of the dosage form or the method or duration of administration or application suggested in the labeling, 21 CFR Part 310.3.

The June 10-17, 2004, inspection at your manufacturing facility, Nutraceutical Labs, Inc., Phoenix, Arizona, also revealed violations of CGMP regulations (21 CFR sections 210 and 211), which cause these products to be adulterated within the meaning of §501(a)(2)(B) of the Act. We acknowledge your letter, dated July 12, 2004, outlining corrective actions at this facility. Although some of these corrective actions adequately address the inspectional observations, significant CGMP deficiencies remain. These CGMP deficiencies include:

This letter is not intended to be an all-inclusive list of deficiencies at your facility. A form FDA 483 was issued and discussed with you at the conclusion of the inspection. It is your responsibility to ensure adherence to each requirement of the Act and its implementing regulations.

We request that you take prompt action to correct the noted violations. Failure to promptly correct these violations may result in enforcement action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil penalties.

Please notify this office in writing within fifteen working days of receipt of this letter of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to identify and prevent the recurrence of similar violations. If corrective action cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.

In addition, we note that the labeling for some of your products states that the products contain androstenedione. The Controlled Substances Act (CSA) (21 USC 801 et seq.) was recently amended by the Anabolic Steroid Control Act of 2004 (PL 108-358). This amendment becomes effective on January 20, 2005. Once effective, androstenedione will be considered an anabolic steroid and a controlled substance under Schedule III of the CSA. Controlled substances are subject to the authority of the U.S.

Drug Enforcement Administration (DEA), the agency with primary responsibility for the regulation of controlled substances. Manufacturers, distributors, and dispensers of controlled substances are required to register with the DEA and comply with a number of requirements (21 USC 822). In addition, controlled substances are subject to detailed security requirements, recordkeeping requirements, as well as labeling and packaging regulations (see 21 CFR Parts 1300-1308). Failure to comply with all of the provisions related to Schedule III substances can lead to significant penalties (21 USC 841-864). Please contact the DEA for additional information.

If you have any questions regarding this letter, please contact Mariza M. Jafary, Compliance Officer, 949-608-2977.

Your written reply should be addressed to:

Pamela Schweikert
Director, Compliance Branch
Food and Drug Administration
19701 Fairchild
Irvine, CA 92612-2446

Sincerely,
/s/
Alonza E. Cruse
District Director

cc: Joseph Rannazzisi
Drug Enforcement Administration
Washington, DC 20537

This page was revised on October 5, 2005.

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