FDA Warns About Hair Loss from Total Body Mega Formula
I read that the FDA has issued a warning about the oral supplement Total Body Mega Formula being unsafe because of high selenium and chromium levels. So my question is why does the FDA not have control over the sale of these supplements, but they do have control over the recall of them?
I saw the official FDA warning and the Center for Disease Control advisory (PDF file). Apparently it took the Florida Department of Health to send reports to the FDA about the potential toxicity of Total Body Mega Formula and Total Body Formula before they were actually looked at by the FDA. The reason for this is because as dietary supplements, there isn’t a requirement of the FDA’s approval processes for safety or effectiveness. This is quite unfortunate, and just goes to show that you really don’t know what could possibly be in these supplements. So for these particular products the FDA found that, “In all cases, the reactions included significant hair loss, muscle cramps, diarrhea, joint pain and fatigue.” Yikes.
The FDA itself didn’t recall the product — after they issued their warning, the manufacturer voluntarily recalled the toxic products to avoid lawsuits and more bad press.
Do the selenium and chromium levels contribute to MPB or a form of reversible hair loss? And is this the same supplement as the Mega Man with DHEA? For the record, not all GNC Mega Man products have DHEA in it, only the one aimed at virility.
Derek,
Many natural products carry the term “Megaâ€, etc. The recalled products are not related to GNC, which you mention, but to the specific brand manufactured by Total Body Essential Nutrition in Atlanta. To answer your additional questions, the selenium and chromium amounts, which are the only items noted by the FDA to be excessively high, did contribute to the syndrome of nausea, vomiting and diarrhea, joint pain, fatigue, hair loss, and tingling/abnormal sensations in the hands and feet. No mention has been made of whether the hair loss is reversible in the affected individuals. The two recalled products in question (Total Body Formula in the flavors of Tropical Orange and Peach Nectar and Total Body Mega Formula in Orange/Tangerine flavor) are not the same as Mega Men with DHEA, which is manufactured by GNC. However, as with all “natural†and unapproved substances, it is “buyers beware.†You do not know what you are truly getting (or the safety and effectiveness), as these products do not have to go through an approval process by any regulatory body.
My dad was taking total body formula and became ill. He had aches,pains,his finger nails and toe nails became red and inflammed. Many of his finger nails and toe nails fell off.He developed blisters on his fingers and feet. All of his hair fell out and he developed a rash on his scalp. After going to his doctor and having his blood work done it was shown that he had very high level of selenium.My mother suffered with the finger nail problem ,but she did not have as a severe a hair loss.This was very distressing to him,because he is so health conscious.He has spent the last three months trying to get better and going to his doctor appointments for advice and treatments.The doctor is having to restrict his diet, because some foods can make the situation worse.His hair is coming back,but he continues to wear bandaids on the few finger nails he has left in a futile attempt to save them.