DSHEA:Is this the beginning of the end?

Despite our most valiant efforts, it looks like we’re losing the fight with the EU to safeguard our vitamins and traditional medicines. But throughout, we were always able to look to the USA as an example of consumer power over the large multinationals.
Back in the early 1990s, America’s vitamin industry faced a similar threat to that being posed by the EU. But there was such an outcry that Congress safeguarded vitamin supplies in the Dietary Supplement Health and Education Act of 1994 (DSHEA). The deal was simple: don’t make any health claims for the products on the labels, and you can freely distribute and sell them.
There have been a few attempts to amend, or even overthrow DSHEA in the last couple of years, but they have so far failed.
But the threat is getting stronger. Last week the Food and Drug Administration (FDA) announced three major regulatory initiatives to change DSHEA.
The FDA says it intends “to improve the transparency, predictability, and consistency of its scientific evaluations and regulatory actions to protect consumers against unsafe dietary supplements and dietary supplements making unauthorized, false, or misleading claims”.
The process begins with a “signal detection”. Signals of a possible safety concern can come from Federal, state and local counterparts; adverse event reports; foreign regulatory actions; media reports; information from consumer groups; and consultation with experts.
This may sound reasonable enough, but we understand that it is anything but. It will become open season for anyone to make claims about any supplement, which may quickly lead to its removal from the shelves.
Our friends in the States have been warning us that once the EU restrictions were introduced, the USA would follow. It’s just happening sooner than even we thought.
Perhaps we could negotiate for a black box warning instead.

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Written by What Doctors Don't Tell You

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