NEW YORK (Good Medical) – The Food and Drug Administration announced Monday its intention to step up its food supplement control business, which has grown to an industry of more than $ 40 billion with over 50,000 products. The agency warned 17 companies for making illegal claims about the ability of their products to treat diseases.
Here's what the FDA announcement means:
Q: How are food supplements regulated?
A: Dietary supplements, including vitamins, are more regulated than foods. They can make statements similar to those found on cereals or snack bars, such as "calcium strengthens bones". But they can not contain medicinal ingredients nor claim to treat diseases such as Alzheimer's disease, cancer or diabetes.
Q: Does the FDA plan to change this rule?
FDA Commissioner Scott Gottlieb said the agency was not questioning the provisions of the 1994 Dietary Supplements Act. He said that dietary supplements are regulated as foods because they are less risky than drugs.
"Nothing in what we are doing would attempt to re-examine" the existing standard, he said.
Instead, the agency addresses critical that he has not imposed rules prohibiting supplements from containing drugs or being marketed like them. Gottlieb said the risk posed by these illegal products has increased with the industry.
The FDA's food supplement review group has 23 employees, he said, and plans to strengthen surveillance of products that are the subject of illegal health claims.
Q: What about supplements that do not report sickness?
A: Qualified health claims on dietary supplements can lead people to believe they are more effective than they are, said Peter Lurie, a former FDA official who now heads the Center for Science in Food Science. the public interest. Lurie noted that the FDA did not review such applications prior to commercialization.
"It's very difficult to engage in this industry in a global way when the law interferes with the agency to the extent it does," he said.
Dr. Pieter Cohen, an associate professor at Harvard Medical School, said dietary supplements were useless for most people unless a doctor recommended them for a specific reason. He noted that there are exceptions, such as women who might have the intention of becoming pregnant.
Q: Does the FDA plan to change the rules for supplements?
A: The FDA is still trying to figure out how it could strengthen control, but one possibility is to create a mandatory database on dietary supplements to improve transparency and facilitate enforcement. He also said he was developing a way to alert people more quickly and consistently about supplements containing illegal ingredients.
The Council for Responsible Nutrition, the dietary supplement industry group, said it was eager to work with the FDA and praised Gottlieb for "eliminating the bad actors".
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