FDA CGMP for Dietary Supplements: Final Rule

June 22, 2007

FDA CGMP FOR DIETARY SUPPLEMENTS: FINAL RULE PUBLISHED ON 06/25/07

On Monday, June 25, 2007, the FDA will publish in the Federal Register

their final rule entitled " Current Good Manufacturing Practice in

Manufacturing, Packaging, Labeling, or Holding Operations for Dietary

Supplements " (Docket No. 1996N-0417). The Final Rule will take effect

60 days after publication.

Compliance is expected within 12 months for firms with 500 or more

employees. The compliance date is extended to 24 months for firms with

20 - 499 employees, and to 36 months for businesses with fewer than 20

employees. For very small establishments, initial compliance (setup)

costs are now estimated at $26,000, and annual compliance costs at

$46,000. (Table 35, pre-publication copy of final rule)

The Final Rule does not exempt individual herbalist practitioners or

colleges that teach herbal medicine. However, the FDA states " ...we

have determined that it would be appropriate for us to consider the

exercise of our enforcement discretion in deciding whether to apply

the requirements of this final rule to certain health care

practitioners, such as herbalists, acupuncturists, naturopaths, and

other related health care providers. " (p.156, pre-publication copy of

final rule)

That is to say, FDA will now have the authority to consider individual

herbalists as manufacturers of dietary supplements. FDA may intervene

with herbalists to enforce the final rule whenever it wants to.

Considering the exercise of enforcement discretion is no guarantee of

such discretion. No exemption from the rule has been granted to

individual herbal practitioners.

The final rule and its supporting documentation run over 800 pages,

with many changes to the proposed rule. Full assessment will take

some time, and I will file a more comprehensive report at a later date.

David C. Kailin, Ph.D., M.P.H., L.Ac.,

Author, Quality In Complementary & Alternative Medicine

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