Facebook Pixel

FDA Consumer Protections and Alternative Menopause Treatments

By HERWriter
 
Rate This
2 / 7

Existing Ingredients

The Dietary Supplement Health and Education Act (DSHEA) of 1994 says ingredients that were already in the food supply prior to 1994 are allowed to remain on the market. If it’s a new ingredient (since 1994) the manufacturer submits a new dietary ingredient supplement application to the FDA.

For example, vitamin C, which was considered a grandfathered-in ingredient that’s been around for ages, is not regulated. The challenge to consumer protection is not so much the new, individual ingredients that must earn approval but finished products that subsequently hit the market.

Imported products can be especially tricky. “It’s really, really difficult for us to prove that something is dangerous,” Meyer said.

Colin Dunn/Flickr

The standing medical opinion is that up to 75 percent of American women suffer hot flashes at some point in their lives. This hot flash phase can last from months to over 14 years for an unlucky few, according to the latest findings of the Study of Women’s Health Across the Nation (SWAN).

The good news for these masses of menopausal women is that seeking relief from nasty overheating and the drenching cold sweat that usually follows has never been more promising. Estrogen therapy is the most common choice among medical professionals, but selective serotonin reuptake inhibitors (SSRIs) are widely accepted as a good alternative for some women, including breast cancer survivors who are not candidates for estrogen therapy or those who shy away from taking estrogen.

However, self-treating with over-the-counter dietary supplements such as black cohosh, known to ease menopause symptoms, takes consumers from the premarket approval realm of drugs to the buyer-beware market of herbals, botanicals or amino acid substances. The above two classes of drugs must meet full premarket approval by the Food and Drug Administration (FDA). Consumer protections are considerably watered down when women choose to dip their toes into the pool of herbal supplements.

Sources:

FDA Press Officer Lyndsay Meyer via phone conversation November 2, 2015. https://www.linkedin.com/in/lyndsaymeyer

Dietary Supplements: What You Need To Know. National Institutes of Health, Office of Dietary Supplements. Retrieved November 2, 2015. https://ods.od.nih.gov/HealthInformation/DS_WhatYouNeedToKnow.aspx

Reviewed November 23, 2015
By Philip Sarrel, M.D. and Lorna Sarrel, M.S.

Read more in Your Guide for Menopause & Hot Flash Treatment Options

Your Guide for Menopause & Hot Flash Treatment Options

Insomnia: When Menopause Keeps You Up At Night

Insomnia: When Menopause Keeps You Up At Night

Advice for My Daughters About Menopause

Advice for My Daughters About Menopause

Does Menopause Make Your Body Age Faster?

Does Menopause Make Your Body Age Faster?

What Does Menopause Have to Do With Heart Disease?

What Does Menopause Have to Do With Heart Disease?

All in Your Guide for Menopause & Hot Flash Treatment Options
>

Get Hot Flashes Email updates

Receive the latest information around hot flashes. Sign up now!