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Washington • The most passionate consumers and the most aggressive nutritional supplement companies are always on the lookout for the next breakthrough pill or juice.
And while these products are not as strictly controlled as drugs, the supplement industry is required to submit safety information to the federal government before rolling out a new product.
The problem is many don't.
Daniel Fabricant, the director of the Division of Dietary Supplement Programs at the Food and Drug Administration, estimates that 60,000 ingredients are sold as dietary supplements in the United States, but the FDA has received only 700 new dietary ingredient applications since the last major supplement law passed in 1994.
"That is 700 total. That is not successful," Fabricant said.
Congress agrees, which is why it required the FDA to spell out what it expects from the supplement industry by the end of June and the outcome of this "guidance document" could be huge.
It's possible the FDA could require health food stores to pull thousands of products off the shelves as its scientists make sure the products won't harm consumers. The new dietary ingredient reviews only apply to ingredients introduced to the market after October 1994, when the law was signed. Any product sold before then is grandfathered in and considered safe.
The 75-day reviews have nothing to do with the potential health benefits of supplements. They are only to determine if there is any potential for health problems.
The supplement industry has complained current rules are confusing and say they are willing to submit safety data when necessary.
Fabricant, a former spokesman for a dietary supplement trade group, called this summer "a critical moment for the industry" because it will show whether the companies are willing to back up their talk and comply with the regulations.
His predecessor, Bill Frankos, who now works for supplement giant Herbalife, based in California, says the increased focus on new dietary ingredients is the last piece of the 1994 law to fall into place and it may upend the most peaceful period in the tumultuous relationship between the supplement industry and the FDA.
"That is the shoe that could drop and be a problem," Frankos said. "I think that will put a huge amount of tension on the agency and the industry."