Are probiotics regulated by the Food and Drug Administration?
Probiotics are particularly difficult to classify and regulate. The FDA sees probiotic supplements as something that could be classified as a drug, particularly if you make health claims from their use. They could also be classified as a food additive or as a health food. And there are issues about quality since probiotics are live bacteria. Depending on the product, you can’t be sure of the contents in the package. In order to keep them on health food store shelves for months if not years, they must be lyophilized, which means that the water is removed from the bacteria. A dried out bacteria comes back to life when water is added, but lyophilization is not an easy process. When you actually open the bottle or take your pill or powder, you may not be taking the amount that is claimed to be on the label. Some products don’t have anything alive in them and some products only have 50% of what they claim. As general advice, it’s better to use probiotics that are kept at 4°C and are refrige
