A company's vitamins caused seizures in customers

Over the years, a Woodstock company’s fruit-flavored vitamin supplement gained a loyal following. Customers swore it made them healthier and their testimonials persuaded friends and family to take it, too.

They never imagined it would be the cause of bizarre and frightening symptoms that stumped their doctors.

Felicia Blasingame of Acworth said she suffered intense nausea and threw up for weeks, but she kept taking Total Body Formula daily because she felt she needed the nutrients. Her knees became so painful she had to drop a ballet class, she said, and her long hair fell out in clumps.

TOTAL BODY FORMULA RECALL

Products covered by the recall, announced in March:
• Total Body Tropical Orange -- lot nos. 4016801, 4024801 and 4031801
• Total Body Peach Nectar -- lot nos. 4016802 and 4031802
• Total Body Mega Orange/Tangerine -- lot no. 4031803

Consumers should stop taking these products and consult a health professional if they've experienced adverse reactions.

To report an adverse reaction to a dietary supplement or drug:

FDA's MedWatch program at 1-800-FDA-1088 or online at www.fda.gov/medwatch/how.htm

To learn more about recalls and safety alerts involving dietary supplements and other FDA-regulated products:www.fda.gov/opacom/7alerts.html

At least 197 people in a dozen states — 53 of them in Georgia — were sickened earlier this year after taking the liquid supplement Total Body Formula. Their hair fell out in clumps, their fingernails fell off. They suffered nausea, vomiting and fatigue. Some had disabling joint pain, according to the Centers for Disease Control and Prevention and state health officials.

Doctors treating 21-year-old Felicia Blasingame of Acworth this spring first thought she had the flu, then tested her for everything from parasites to lupus to rheumatoid arthritis, trying to figure out what was causing her nausea, seizures, knee pain and hair loss, she said.

Edgar Gurley, 78, of Marietta said he went from being active and healthy to suddenly in January battling a cascading array of symptoms, including diarrhea, fatigue and confusion. Gurley said doctors struggled to explain why his blood chemistry and thyroid levels were out of whack, his kidneys were failing and his hair was falling out.

As their symptoms worsened, Blasingame and Gurley said they continued to take their daily 1-ounce dose of Total Body Formula, thinking it was critical to their health.

Yet several batches of Total Body Formula and Total Body Mega Formula contained hazardous amounts of the mineral selenium — up to 40,800 micrograms per serving, 200 times the amount listed on the product’s label, according to the U.S. Food and Drug Administration.

The FDA is still investigating how this happened, and state health officials are still tallying the human toll.

Because of several pending lawsuits, lawyers for three companies involved in the manufacture and sale of Total Body products declined to discuss what happened.

3 FDA warnings

Total Body is one of more than two dozen dietary and herbal supplements that in the past year have been the subject of product recalls or FDA warnings because of various safety issues.

Officials at the Council for Responsible Nutrition, an industry group that represents major supplement companies, said problems such as those with Total Body Formula or recalls involving tainted products are rare.

“The overwhelming majority of dietary supplements on the market are safe and they do what they claim to do,” said Andrew Shao, the council’s vice president for scientific and regulatory affairs.
Problems with Total Body Formula products began in January as the first victims fell ill, but health officials were unaware for two more months. Alarm bells went off in early March after a Florida chiropractor notified state health officials about a cluster of patients with unusual hair loss, muscle cramps, nausea and diarrhea. All, it turned out, had used Total Body supplements.

“If he hadn’t said anything to anybody, we might not have known about it,” said Roberta Hammond, the Florida Department of Health’s food and waterborne disease coordinator.

On March 27, the FDA issued the first of three warnings, advising consumers not to use Total Body Formula in tropical orange and peach nectar flavors and Total Body Mega Formula in orange/tangerine flavor.

Tests by the FDA found the supplement contained high amounts of selenium as well as levels of chromium that were 17 times higher than recommended. Total Body recalled 1,484 bottles of the product from the market. The symptoms users experienced are signs of selenium toxicity, the FDA said.

“Some people have been pretty debilitated by this,” said Paul Melstrom, a CDC Epidemic Intelligence Service officer assigned to the Georgia Division of Public Health.

Severe joint pain and muscle cramps have caused people with physically demanding jobs to miss work. “That’s been a big issue with some folks,” Melstrom said. People who already had arthritis were particularly hard hit, he said. “A few found it very hard to even walk around.”

Others have been traumatized by going bald or losing their fingernails, he said.

State officials continue to track the progress of Georgia’s 53 known cases.

Melstrom is in the process this month of doing a third survey to follow up on checks made in April and June.

He has found that as time has passed and the product has left Total Body users’ systems, some symptoms have improved while others have worsened.

When he made his last round of calls in mid-June, the number of people who still suffered from nausea, vomiting and diarrhea had dropped dramatically since he first interviewed them in the spring. Fewer people had joint pain, but still more than half were affected.

The number of people reporting hair loss increased from 63 percent to 81 percent, he said. Those reporting fingernail discoloration or loss increased from 45 percent to 63 percent. These increases are to be expected because it takes longer for selenium to reach hair and nails, which have little blood flow, Melstrom said.

New regulation

Nobody knows how many consumers are harmed each year by dietary supplements. A recent study of 275 calls to a California poison control center about dietary supplements concluded that most adverse reactions are likely minor. But the study found that moderate to severe reactions, even death, occur, especially involving products containing stimulants such as caffeine and yohimbe.

A new regulation that took effect late last year requires for the first time that supplement companies notify the FDA about customer illnesses. But they only have to report serious, life-threatening or deadly events. Still, in the first six months of this year, supplement firms have filed 368 of these mandatory reports, the FDA said.

Most of the symptoms experienced earlier this year by users of Total Body Formula supplements — hair loss, nausea, joint pain and the like — would not qualify as serious enough for mandatory reporting, FDA officials said.

Despite health alerts sent out by the FDA and the CDC, Blasingame and Gurley and their doctors remained unaware throughout the spring that federal officials had an explanation for the illnesses.
Gurley — who had been to numerous specialists and had met with a surgeon about removing his thyroid — said he didn’t learn of the Total Body recall until late April when he went back to a Marietta health food store to get another bottle before he ran out.

Blasingame didn’t know there was a problem with the product until May — after numerous doctors’ appointments, a trip to the hospital for seizures and invasive gastrointestinal tests. She was in the office of a new doctor, a dermatologist, seeking a second opinion about why her long hair was falling out by the handful. The doctor had seen the alerts and asked her whether she took the supplement.

“At first I was really relieved to know the reason for everything that was going on,” Blasingame said. “After that, I got really angry because this was something that could have been prevented.”

Blasingame and Gurley have sued Total Body Essential Nutrition, the supplement’s seller. They and consumers in several other states also have sued two other firms that manufactured the product for Total Body: TexAmerican Food Blending of Hot Springs, Ark., and Wright Enrichment of Crowley, La.

Total Body Essential Nutrition only markets and sells the product, said Rod Cate, an attorney for the company. “They have nothing to do with the manufacturing process. [Total Body] relies upon the manufacturers to do it correctly,” he said.

No treatment

Wright Enrichment attorney Dino Gankendorff said the company denies any liability and stands behind its product. An attorney for TexAmerican declined to comment.

Jennifer Thomas, enforcement division director in the FDA’s Center for Food Safety and Applied Nutrition, said she can’t say what the agency’s investigation has found so far.

There’s no treatment for selenium or chromium poisoning, federal health officials said, and symptoms are expected to go away on their own over time. But recovery will vary depending on how much of the product a person consumed and their underlying health problems.

Blasingame says she’s no longer nauseated, her energy is returning and her hair is growing back. But she worries whether there’s been any long-term damage to her liver or kidneys.

Gurley said he continues to suffer serious health problems that he blames on the product.

“I am very close to having to go into dialysis,” said Gurley, whose doctor is checking his blood every two weeks. Kidney failure can be caused by excessive consumption of chromium.

Gurley said he’s lost the ability to drive and suffers from continued gastrointestinal problems that make it impossible to sleep or go to the American Legion hall to play cards with his buddies.

While he worries about his own future, he fears there may be others who are still taking the product. Each 32-ounce bottle contained enough doses for a month. “I’m sure there are people who still don’t know,” he said.