The Food and Drug Administration recently warned people to stop taking a dietary supplement called Vita Breath, touted as an aid for asthmatics, because it contains significantly higher levels of lead than is allowed in candy.
Wait. There are acceptable levels of lead in candy? The next question that sprang to mind: Do makers of supplements have to comply with a candy rule?
The answer to the first question is yes. Up to 0.1 parts per million of lead is OK in candy expected to be consumed by small children, according to guidance put out by the FDA in 2005.
That amount was actually ratcheted down from the agency's previous acceptance of 0.5 ppm 10 years earlier. The change came about the same time as the big candymakers reached a settlement with the Center for Environmental Health in California and agreed to test candies for lead.
The product on the hook this time, however, is not a candy with a small amount of lead, but a dietary supplement found to contain a lot of it.
Dietary supplements are a class of products that are not quite food, nor are they drugs, but they fall somewhere in between. The agency has had a regulatory tug-of-war with their makers for decades over health claims and the accuracy of their ingredient listings. It may come as a surprise to many people that FDA has less authority over supplements than over drugs and medical devices.
So do these supplement makers have to comply with FDA's candy lead limits?
Update: From Michael Kashtock in FDA's food safety office, the answer is not technically, but the candy example helps consumers get an idea of how much lead they're finding in this supplement.
"If the level of lead is high enough to cause risk — FDA can consider it not in compliance with the laws," he told us.
FDA can take a range of actions when it finds a lead or other heavy metal problem in a product, ranging from seizure to injunctions and detentions.
Kashtock says the agency must be vigilant, even as the amounts of lead in food have generally gone down in the U.S. since we stopped using lead in gasoline, other countries where our food comes from have not.
For now, FDA is warning consumers not to buy Vita Breath.
Vita Breath is manufactured by American Herbal Lab Inc. of Rosemead, CA, and is sold over the Internet and at health fairs. The website claims the stuff "promotes better health for people with asthma" and "supports healthy Lung Energy and Respiratory System."
The ingredients list for Vita Breath includes things like jujube, apricot kernel, white fungus, and tangerine peel. No mention of lead.
FDA says the New York City Department of Health and Mental Hygiene reported a patient with lead poisoning who took Vita Breath and two other herbal products. The department analyzed a sample of Vita Breath and reported it contained 1,100 ppm of lead — more than 10,000 times higher than FDA's maximum recommended level for lead in candy.
High levels of lead in the blood can damage to the nervous system and internal organs. Acute lead poisoning may cause abdominal pain, muscle weakness, nausea, vomiting, diarrhea, weight loss, and bloody or decreased urinary output, FDA says. Children are particularly vulnerable.
The agency is running its own lead tests on Vita Breath, and an agency spokeswoman suggested we check back for the results in a few days. It may decide to take further action based on its findings, Kashtak said.
We left a message for Vita Breath officials seeking comment on the FDA action, but haven't heard back from them yet.