FDA Recall, Aromatase Inhibitors: What Does It Mean?

BY Dr. Arianna Staruch, ACHS Academic Dean

In case you've seen the FDA post Aromatase Inhibitors in Products Marketed as Dietary Supplements: Recall are are wondering what it all means ...

Aromatase is a cytochrome P450 (CYP) 19 enzyme that is critical in the metabolism of estrogen. In the ovary it is responsible for de novo production of estrogen from cholesterol. In tissues outside the ovary, aromatase converts androgens secreted by the adrenal gland into estrogen.

Aromatase is present in breast tissue and breast fat. Since 60% of premenopausal and 75% of postmenopausal breast cancer patients have estrogen-dependent tumors, this enzyme has been the target of drugs known as aromatase inhibitors. Breast tumors contain an abnormally high level of aromatase that generates a large amount of estrogen. Drug companies began developing inhibitors by modifying androgens, and 4-hydroxyandrostenedione (generic name of formestane) was the first aromatase inhibitor approved for use in breast cancer.

So how does this relate to dietary supplements? Since aromatase is responsible for converting testosterone to estrogen, and increasing testosterone has long been the goal of body builders, adding aromatase inhibitors was thought to be a new way of increasing testosterone and increasing muscle mass. Basically, it is a continuation of the anabolic steroid story made famous by professional athletes.

There are a number of natural aromatse inhibitors found in plants, such as mangosteen and resveratrol (found in grapes). These tend to have very low activity and studies are being done to look at their long-term effects on breast cancer incidence.

So here is the confusion, one of the products recalled by the FDA is called “iForce – Reversitol”, made by I Force Nutrition, a company that caters to the body building community. Resveratrol itself is NOT being recalled, but this product is. The reason is that this product, and others on the recall list, contain the added substance ATD (1,4,6-Androstatriene-3,17-Dione), which is a synthetic aromatase inhibitor. It is basically an unregulated drug, with drug-like side effects. The I-Force product information claims: “An extremely effective AI (Aromatase-inhibitor), ATD eliminates the production of estrogen in the body” and “Similar to Nolvadex, Trans Resveratrol works at the receptor level to block estrogen receptors."

You may know Nolvadex by its generic name, Tamoxifen.

So from a regulatory standpoint, this company added a drug-like substance to their products, compared their product to a drug in their product materials, and failed to show that this substance is Generally Recognized as Safe (GRAS).

The bottom line is, through this recall the FDA is not attempting to restrict access to the dietary supplement resveratrol, but is warning consumers about potential adverse health effects from a product that is not following FDA guidelines.

For more information about estrogen metabolism, aromatase and aromatase inhibitors, see the following papers:

Biochemistry of Aromatase: Significance to Female Reproductive. Physiology1. Kenneth J. Ryan:
http://cancerres.aacrjournals.org/content/42/8_Supplement/3342s.long

Aromatase Inhibitors in the Treatment of Breast Cancer:
http://edrv.endojournals.org/cgi/content/full/26/3/331

History of Aromatase: Saga of an Important Biological Mediator and Therapeutic Target; R. J. Santen, H. Brodie, E. R. Simpson, P. K. Siiteri and A. Brodie: http://edrv.endojournals.org/cgi/content/full/30/4/343

Moroccan Argan Oil Antioxidant-Rich, Potential Skin and Dietary Support

Do you use argan (Argania spinosa) oil?

Also called Morocco ironwood, argan oil is from the soapwood family and has a history that can be traced back more than two million years.

Argan is a culinary oil and a cosmetic oil, and has traditionally been used in both skin and hair care. Medicinally, argan oil has been used to help heal wounds and with rheumatism and arteriosclerosis.

The oil, pressed from the trees’ kernels, contains more than 80% unsaturated fatty acids, vitamin A, and large quantities of vitamin E antioxidants and sterols; it may be very nourishing when used on the skin and may be effective as a dietary supplement.

Currently, there are about 50-60 women’s cooperatives in Morocco producing argan oil the traditional way. These cooperatives are growing in number as a resource for Berber women to revive the traditional hand-pressing method of extracting argan oil and to ensure an income. Read more about the women’s cooperatives on the Targanine website.

Traditionally, argan oil is hand-pressed by the Berber women. First the trees’ fruit pulp is allowed to dry; then it is removed. The remaining nuts are cracked between two stones so the kernels can be used undamaged. The kernels are lightly roasted and then ground by hand. An oily paste forms and the oil is removed through the use of lukewarm water and constant kneading. It is then decanted.

The picture in this blog post is from ACHS President Dorene Petersen, who recently hiked through the Atlas Mountains in Morocco and watched the women hand pressing the oil. Check back with ACHS Facebook for more info from Dorene about the medicinal properties and products of argan oil, and pictures from the women's cooperatives.

Here are some links to recent research articles about potential medicinal properties and uses of argan oil that you may find interesting:

1. Effect of dietary argan oil on fatty acid composition, proliferation, and phospholipase D activity of rat thymocytes

2. Consumption of argan oil (Morocco) with its unique profile of fatty acids, tocopherols, squalene, sterols and phenolic compounds should confer valuable cancer chemopreventive effects

3. Effect of Argan Oil on Platelet Aggregation and Bleeding Time: A Beneficial Nutritional Property

Share your experience using argan oil. Do you prefer it to olive oil? Is it more moisturizing than your traditional skin care base oil?