What does the FDA intend with its CGMP Rule?

The FDA's new Dietary Supplement Current Good Manufacturing Practices (cGMPs): I’m reading them, but so can you, at: http://www.cfsan.fda.gov/~dms/dscgmps6.html

(467 pages when downloaded to MS Word; the actual rule doesn’t start until page 426, after 359 comments…).

Here are some comments by FDA, from the commentary preceding the new rule, that tell us a lot about where the present administration of FDA wants to take us:

“…we disagree with the comments asserting dietary supplements have a track record of safety such that dietary supplement CGMP requirements are unnecessary. Section 402(g) of the act does not require us to establish a ‘bad’ track record of safety in the manufacture of dietary supplements before we may issue a dietary supplement CGMP rule. Furthermore, we disagree with the comments comparing dietary supplement safety to drug safety; there are different statutory requirements, different regulatory requirements, and different safety evaluations for dietary supplements and drugs.”

And this, from the economic impact section:

“We find that this final rule will have a significanteconomic impact on a substantial number of small entities.... Establishments with above average costs, and even establishments with average costs, could be hard pressed to continue to operate. Some of these may decide it is too costly and either change product lines or go out of business.... 140 very small [less than 20 employees] and 32 small dietary supplement manufacturers [less than500 employees] will be at risk of going out of business.... costs per establishment are proportionally higher for very small than for large establishments....The regulatory costs of this final rule will also discourage new small businesses from entering the industry.”

This makes explicit what many critics of the FDA have believed for some time: the Agency is hopelessly "in the pocket" of the "Bigs" - Big Pharma, Big Chema, etc.

Can we hope there will be a change of Agency attitude when the Administration changes in about a year and a half; especially if the good doctor from Texas replaces the current Texan occupying the White House?

Certainly it is time to raise the issue of why are Foods and Drugs (and Medical Devices) being regulated by the same Agency? If the FDA were restricted to policing the drug industry -- a job it now does poorly at best -- the public might be better served. Without adding to the bureaucracy, let's transfer food safety to the Department of Agriculture and then let the Federal Trade Commission do what it is supposed to do, policing the substantiation of advertising claims, when the public complains.

It is time to refocus the Food and Drug Administrtion into a Drug and Medical Device Administration. And get them away from our foods, dietary supplements and natural remedies.

FDA issues cGMPs!

FDA issues Good Manufacturing Practices requirements

Excerpts from the FDA announcement follows. The terminology is fairly much what I had predicted in previous postings, focusing on “identity, purity, strength, and composition” – however, the enforcement procedures seem more extreme than had been predicted from the draft rule and may represent a further ratcheting of enforcement in general. Expect significant opposition to ingredient testing and other "drug" like requirements. The DSHEA law provides that vitamin industry GMPs are to be patterned after food rules, not drug standards.

Announcement: “The U.S. Food and Drug Administration today (06/22/07) announced a final rule establishing regulations to require current good manufacturing practices (cGMP) for dietary supplements. The rule ensures that dietary supplements are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled. ***

The regulations establish the cGMP needed to ensure quality throughout the manufacturing, packaging, labeling, and storing of dietary supplements. The final rule includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product. It also includes requirements for recordkeeping and handling consumer product complaints. ***

Under the final rule, manufacturers are required to evaluate the identity, purity, strength, and composition of their dietary supplements. If dietary supplements contain contaminants or do not contain the dietary ingredient they are represented to contain, FDA would consider those products to be adulterated or misbranded.

The aim of the final rule is to prevent inclusion of the wrong ingredients, too much or too little of a dietary ingredient, contamination by substances such as natural toxins, bacteria, pesticides, glass, lead and other heavy metals, as well as improper packaging and labeling. ***

FDA also is issuing an interim final rule that outlines a petition process for manufacturers to request an exemption to the cGMP requirement for 100 percent identity testing … if it can provide sufficient documentation that the reduced frequency of testing requested would still ensure the identity of the dietary ingredient. ***

The final CGMP and the interim final rule are effective August 24, 2007. To limit any disruption for dietary supplements produced by small businesses, the rule has a three-year phase-in for small businesses. Companies with more than 500 employees have until June 2008 to comply, companies with less than 500 employees have until June 2009 to comply, and companies with fewer than 20 employees have until June 2010 to comply with the regulations.

http://www.cfsan.fda.gov/~dms/dscgmps6.html