Friday, September 8, 2006

09/08/06 - AERs and QCs - more regs for industry


For those of you who are new to the VLUM, the purpose of this e-memo is to update the Vitamin Lawyer and Vitamin Lawyer News web sites for my contacts and client list. You got on this e-list by opting in or becoming a client of the Vitamin Lawyer Consultancy. If you want to be taken off the list, please “reply” to this email with the word “remove” in the subject line. On the other hand, you are welcomed to forward this to your own elist…R

Here are the items I am covering in this e-memo:

1. Adverse Event Reporting – the latest on the bill to grant the FDA new powers to control Vitamins.
2. Ephedra re-banned!
3. The Vitamin Lawyer Oversight Seal and Quality Control (QC) Practices.


Is "AER" coming to the Dietary Supplement world? The Dietary Supplement and Non-Prescription Drug Consumer Protection Bill, S.3546 was introduced on June 21st and was put on the Legislative Calendar on September 5th. It is expected to be voted on before the election this November.
Says FDA News: “The Senate is planning to vote on one drug safety bill this week and another before the end of the month, a spokesman for Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Mike Enzi (R-Wyo.) said. First up will be "The Dietary Supplement and Nonprescription Drug Consumer Protection Act," which would amend the Federal Food, Drug, and Cosmetic Act (FDCA) to require OTC and dietary supplement companies to provide notice of serious adverse events to the FDA. The bill… is expected to go to the Senate floor this week..” Some suggest that AER will be bad for the industry and I understand their concerns: nutrients are foods and should not be subjected to “drug-like” controls. But consider, if AER rules had been in place a decade ago, would Tryptophan have been banned because one manufacturer made one bad batch? Would Ephedra have been banned if a reporting system had been in place to show the actual safety of that herb, when used as directed? You can get more information at:

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An appeals court has just overturned Judge Campbells’ well-reasoned decision from April 2005, that “…the legislative history of the DSHEA indicates that Congress generally intended to harmonize the treatment of dietary supplements with that of foods when it added the dietary supplement subsection...” This appeal court action is being appealed further to the US Supreme Court that will thereby have an opportunity to confirm that Nutrients are Foods, not Drugs!


An important part of the developing “Current Good Manufacturing Practices” (cGMPs) in the vitamin industry is Quality Control. The Vitamin Lawyer has developed format Operations Manual sections for QC that tracks FDA requirements and the probable requirements of the AER bill. One of the keys to meeting the new requirements will be standardized QC controls – in a manual format for the FDA to review if (and when) they come to your plant for a surprise inspection. Please contact me if you need help with your Operations Manual.

One way to assure your customers quality claims is to qualify for and post the Vitamin Lawyer Oversight Seal -- the seal is proudly displayed on web sites that meet exacting standards for claim language and disclaimer usage. See for a sample of the Seal. The Vitamin Lawyer’s monthly retainer clients not only have the privilege of using the Oversight Seal, but also receive discounted rates for services. Let me know if you are interested.

That’s all for now. Have a great autumn!

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