Friday, February 23, 2007

02/23/07 - Record Keeping SoP, attacks and opportunities

1. Harvard Joins Anti-Nutrient Crusade
2. The Future for Healthcare: $4.1 Trillion!
3. Record Keeping Short Form SoP


The report speaks for itself, but do note how it is being used to create publicity for the idea of implicitly pre-market controls over nutrients, as though nutrients were not as safe as any other category of food.

“The report, "Vitamins and Minerals: What You Need to Know", gives consumer advice…Directed at the general public, the report could stir up the issue in the nutraceutical industry surrounding what body should give a stamp of approval for supplements, and whether an independent body is needed for such a purpose.

“"Choose products that bear the US Pharmacopeia Dietary Supplement Verification Program (USP-DSVP) mark, which indicates that the supplement manufacturer has complied with certain standards," says the report.

“Via its recommendations, the Harvard report is also critical of dietary supplements that go beyond the vitamin and mineral category.

“"Generally, if you're hoping for phytochemical benefits, you'll do better in the produce department than the supplement aisle," according to the report. "There is virtually no evidence that herbs and other nonvitamin ingredients added to supplements, such as echinacea, are essential for your health."

“The report questions another key area for the supplement industry - the benefit of different sourcing for vitamins in minerals.

“"It doesn't matter whether vitamin C is derived from organic rose hips or synthesized in large batches in a laboratory," says the report. "Your body will use the resulting product similarly."”



FDA News reports today: “”Healthcare spending will continue to grow more quickly than the economy over the next decade … according to a report from economists at the Centers for Medicare & Medicaid Services (CMS). Healthcare spending in 2016 could reach $4.1 trillion, representing 20 cents out of every dollar spent, according to the report, which was published in Health Affairs. In 2006, healthcare spending was $2.1 trillion, the economists estimated. … spending growth will reach 7.8 percent by 2009 because of accelerating medical price inflation and increases in pharmaceutical use. By 2016, health spending could be 19.6 percent of the gross domestic product, the report said.



A primary concern of small, leading edge dietary supplement purveyors is how to deal with the new wave of regulation that seems to be sweeping the industry. The first rule of bureaucracy is, “Are your papers in order?” Well, are they? In the context of current Good Manufacturing/Marketing Practices (cGMPs) your “papers” are the documentation of your business activities, from buying your products, through advertising, selling and shipping them. And then, dealing with customer issues, refunds, recalls, adverse event claims, etc., etc.

To make it as simple as possible, I’ve developed a shorter and simpler version of my 50+ page Standard Operating Procedures/Employee Handbook (SoP/EMs) that is made for smaller, Internet oriented dietary supplement and alternative therapy companies. For an hour of my time, I can customize the Record Keeping SoP format for your company, so you will know what documents you need to keep and for how long. Just email me at with “Record SoP” in the subject line and I’ll let you know what information I need and how you can reserve the time for your SoP.

Well, that’s all for now.
Ralph Fucetola JD

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