Friday, May 11, 2007

05/11/07 - OMB approves cGMPs- S.1082 amend confirmed

VLUeM - 05/11/07 - Vitamin Lawyer Update Memo

1. New GMP Standards Cleared by OMB
2. Vitamin Lawyer Health Freedom Blog: DSHEA Exemption?

1. New GMP Standards Cleared by OMB – as reported on the Internet


Completes Effort to Implement Key Aspect of DSHEA

>Washington – Sen. Orrin G. Hatch (R-Utah) today announced the Office of Management and Budget has given final clearance for good manufacturing practices (GMP) regulations for dietary supplements.
>“Finally!” Hatch said. “This is very good news. Senator Harkin and I have been pushing the FDA to publish these for more than a decade.”

>Hatch is one of the principal authors of the Dietary Supplement Health and Education Act of 1994, which gave the FDA the authority to write GMP guidelines specific to supplements. GMPs are the standards inspectors will use to assure purity, potency, and all the other requirements of clean, legal manufacturing.

The GMPs are expected to be published within the next five weeks.

>“GMPs are crucial because they assure the public that the products they are buying live up to their labels,” Hatch said. “Since it took an unusually long time to issue these final guidelines, I want to review the final version very carefully to make certain they are good regulations. Every indication leads me to believe the Administration was very sensitive to the impact the GMPs might have on the industry, especially on small businesses.”

We are likely to get a look at the GMPs within the next few weeks. I will keep this elist informed of these developments, that I have long predicted. When the GMPs are issued, I will update the standard Vitamin Lawyer Consultancy SOPs (Standard Operating Procedures) to conform. My current formats are outlined at: -- 


2. Vitamin Lawyer Health Freedom Blog

The political situation, as it impacts Dietary Supplements and Alternative Practices is moving so fast that a couple of Update eMemos a month cannot keep up, so I’ve started a blog on these issues: - you need to be aware of the latest developments… and two of those are: (1) Dr Ron Paul, congressman from Texas and presidential candidate, called the draft FDA CAM guidance “an abuse of FDA power…” and (2) despite some confusion on the issue, we have written confirmation from Sen. Kennedy’s office that the Senate did approve SAmend 1022 (94 to 0), exempting DSHEA products from the Kennedy FDA enhancement bill (but, the broader exemption for all food and natural products needs to be added when the House considers the bill). More at

Let Congress hear from you:

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