Monday, June 25, 2007

Good Manufacturing Practices For Dietary Supplements, Gets The Nod

Friday was a good day. I was sitting at a red light when I heard the news:
"The Food and Drug Administration issued long-delayed rules on how dietary supplements are manufactured, packaged, and labeled." 1, 2
- National Public Radio, June 22, 2007
I yelped. I slapped my dashboard. The light turned green.

I spoke about this 13-year-pending FDA rule last month on my post, Good Manufacturing Practices For Dietary Supplements, Waiting For The Nod, where I lamented that this rule, a rule that received legislative approval in 1994, was still not in force.

This isn't the kind of regulation that would limit access to supplements, not outright at least, unless a product was certifiably filthy. It doesn't address safety (Is taking 2 grams of vitamin C a day safe?), or efficacy (Is St. John's Wort effective for use in depression?). It merely establishes enforceable guidelines for supplement quality. These include such things as equipment function and cleanliness, batch testing, sanitation, storage at the proper temperature/humidity/light conditions, record keeping, etc. - things that any business worth its salt, or your dollar, would already have in place.

I hope this means:
  • Less DDT and other pesticides in St. John's Wort, Valerian, Echinacea, Ginseng, and other herbals.
  • Less lead, mercury, glass, and other contaminants.
  • Fewer bacteria and bug parts.
  • A greater likelihood that the strength of the product on the label matches the strength of the product in the bottle
  • A greater likelihood that the identity of the product on the label matches the identity of the product in the bottle.
Some think this rule doesn't go far enough; that it's too little, too late.3,4 I'm not going to be negative. I think it's a good regulation. It moves the supplement industry in the direction of better quality and more trustworthy labeling. A positive response by the public to rules like this opens the door for more in the future.

One aspect I especially like ... these Good Manufacturing Practices apply to foreign companies as well as domestic. Did you know that China provides the US 90% of its vitamin C? As well as the bulk of vitamins A, B12, and E? (I didn't. Thank you, Tim Johnson at the Seattle Times.) According to this rule, businesses anywhere "that manufacture, package, label or hold dietary supplements, including those involved with the activities of testing, quality control, packaging and labeling, and distributing them in the US" are obligated to comply.

Friday was a good day.
1 FDA's press release.
2 If you're inclined, here's the FDA's Final Rule (pdf, 815 pages).
3 Center for Science in the Public Interest: "...the regulations are not as stringent as those for infant formula and low-acid canned foods."
4 Public Citizen: "A final rule issued today by the Food and Drug Administration (FDA) not only is 13 years late but will not do anything to ensure that dietary supplements are safe or effective - a critical necessity."

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