FDA: New Dietary Supplement Safety Rules

The FDA has announced new manufacturing standards for vitamins, herbs and other dietary supplements in order to help ensure quality throughout the manufacturing, packaging, labeling and storing process.

“The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling,” said Robert E. Brackett, Ph.D., director of FDA’s Center for Food Safety and Applied Nutrition.

The rules, which take effect August 24, will require manufacturers to test the purity, strength and identity of their ingredients. The FDA is seeking public comment on the rule. The comment period ends on September 24, 2007. —MEGHANN MARCO

Dietary Supplement Current Good Manufacturing Practices (CGMPs) and Interim Final Rule (IFR) Facts [FDA]
(Photo: Clean Walmart)

Comments

Edit Your Comment

  1. tedyc03 says:

    The comment period ends AFTER the rule takes effect? Isn’t there something wrong with that?

  2. cmac says:

    From the FDA link provided:
    To limit any disruption for dietary supplements produced by small businesses, the rule has a staggered three-year phase-in for small businesses. The final CGMPs is effective in June 2008 for large companies. Companies with less than 500 employees have until June 2009 and companies with fewer than 20 employees have until June 2010 to comply with the regulations.

  3. bluegus32 says:

    CMAC: let me get this straight — if you’re a big lying sack of crap company then you have to comply within one year. If you’re a small time crook then you have longer?

    Well now that doesn’t make much sense.

  4. elavender says:

    Ah, I thought for a second this was effective more recently.. That would give good reason why my favorite green tea supplements aren’t carried at Walmart anyway. They make my life much more.. easier anyway.

    It is good to see regulation though, since supplements/vitamins can basically claim whatever they please.

  5. jerseyjokeboy says:

    Here’s my comment, FDA: You suck balls!!! This organization is nothing but a joke. Big pharma companies pretty much own the people at FDA, since it is the business who must fund most of the FDA agent’s work to approve/deny a drug. As for the off the shelf supplements, companies have almost no limits as to what to put in the can and sell to you, whether the product is good for you or not. Just go down to GNC and hook a look at the “muscle” or “fat burning” supplements. It’s all a ripoff and it’s legal for them to do this. Thanks FDA… Oh, and F U!

  6. Buckler says:

    This is all well and good, but I’m wondering how this will affect “homeopathic” supplements, which are scams anyway, since they rely on near-undetectable trace amounts of ingredients to begin with. Indeed, the clarion call of the homeopath is to include as little active ingredient as possible, often in molecularly-undetectable amounts. How will the FDA deal with that?

  7. QuirkyRachel says:

    Ah but here’s the rub. Even if the supplements are using trace amounts, they’re basically harmless. And, the placebo effect is huge. In fact, there are OTC and prescribed drugs that work only a tad better than a placebo, which is good enough for the FDA. Also, not all of them are trace amounts. You try not being able to get out of bed in the morning because of a back problem and finding that the right dosage of magnesium suddenly makes it possible. If they take that off the shelves, I’ll travel to Canada to get it. seriously