Friday, September 15, 2006

09/15/06 - "promotes and markets... for serious disease conditions"



The FDA issued the following press release last week:


"At the request of ...(FDA), on September 5, 2006, U.S. Marshals seized quantities of Ellagimax capsules, Coral Max capsules, Coral Max without Iron capsules, and Advanced Arthritis Support capsules... valued at approximately $55,000.00."

[Note the following claim that the NEW drug and misbranding provisions apply to dietary supplements as well as to drugs, when the DS is being promoted, in FDA's opinion, as a "drug."]

"The products are alleged to be in violation of the new drug and misbranding provisions of the Federal Food, Drug and Cosmetic Act."

"Although these products are labeled as "dietary supplements," they are being promoted with claims typically associated with drug products. These claims are evident in the products' labeling, including various promotional literature, an audio cassette tape, and two Internet Web sites owned and used by the firm. ..."

"[Company's] labeling promotes and markets these products for serious disease conditions, including but not limited to cancer, arthritis, fibromyalgia and seizures."

[And now, what to expect.]

"Following an investigation of the firm's marketing practices, FDA advised Advantage Nutraceuticals that the claims related to prevention or treatment of diseases in many of its products' labeling make these products subject to regulation as drugs. Despite FDA's warnings, the firm failed to take sufficient steps to come into compliance with the Act. During subsequent inspections, FDA inspectors found that the offending claims were still being made."


Note that "sufficient steps to come into compliance..." was the issue. This case appears to be another example of "guilty until proven innocent" in that no independent third party determined that the steps the company took were "sufficient." The companies that will survive in what is becoming a much stricter regulatory climate are those that are ready to react quickly. Oh, and if you are one of those companies trying to take "sufficient steps," not keeping a large inventory in your main plant is probably a good idea too.

You need to pay attention to your site claims on a continuing basis, and that is what the Vitamin Lawyer Oversight Seal program is all about. See: for details.

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:

------------------------------ Index


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!