Friday, October 19, 2007

10/19/07 - AER Draft Guidance; Health Claims


The Vitamin Lawyer eMemo Archive is 
Being Inaugurated with this Issue of the eMemo.

The eMemo Archive is here:

1. Health Freedom Blog Update & Factoid
2. A Case Study: how NOT to make claims
3. AER draft guidance issued

Counsel Ralph, Atlantic City, Superior Court, 2006

1. Vitamin Lawyer Health Freedom Blog –
New Posting -

Vitamin D and Longevity - “Published in the September 10 issue of Archives of Internal Medicine, the meta-analysis examined 18 previously published studies which had suggested that deficiencies in vitamin D lead to a higher risk of death from cancer, heart disease and diabetes. However - given that these illnesses account for between 60 and 70 percent of deaths in high-income nations - the current analysis indicates the opposite. In fact, those individuals isolated from the studies who did take vitamin D had a seven percent lower risk of death than those who did not take it. "If the associations made between vitamin D and these conditions were consistent, then interventions effectively strengthening vitamin D status should result in reduced total mortality," wrote the researchers, hailing from the International Agency for Research on Cancer in France and from the European Institute of Oncology in Italy -

2. FDA targets company making cancer treatment claims - By Clarisse Douaud

[VL comments: Here is a good example of how NOT to make claims!]

“In another move to prevent dietary supplements infringing on the territory of pharmaceuticals, the US Food & Drug Administration (FDA) has issued a warning to Zeo Health for three of its products…

“Unlike pharmaceuticals, which must go through a series of pre-market approvals, finished dietary supplements need no pre-market approval. Instead, only ingredients not marketed in the US before October 1994 must be approved by FDA before being used in consumer products…

“Unlike, pharmaceutical drugs, dietary supplements are permitted few health claims… "The therapeutic claims on your web site establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease," wrote FDA in a letter to the New York state-based company… FDA objects to …promotion …for cancer prevention and treatment. The agency highlights an example of phrasing to this effect as found on the company's website:

"The scientific community has recently had very positive results on the effect of Zeolite on certain types of cancers. In tests on a variety of tumor types, the treatment with Zeolite led to improvement of overall health status, prolongation of life span, and a decrease in tumor size." The insinuation that the supplement can prevent or treat cancer continues in the dosage information provided by Zeo Health.

"For prevention: As a nutritional supplement, take 2 capsules twice daily. As part of Cancer therapy: As a dietary supplement, take 6 capsules three times daily." [VL Notes: these directions are clearly “treatment” directions.]

“FDA also revealed that Zeo Health claims on its website that the supplement Esdifan is recommended for consumers with irritable bowel syndrome and Crohn's disease. "Esdifan is the most effective relief for diarrhea and bad stomach. Better than any drug on the market....," stated Zeo Health on its company website, according to FDA.

“In its website marketing, Zeo Health leapfrogs from cancer prevention to hangover cures in its product claims.

“The company claims that its Zeolite supplement absorbs toxins associated with alcohol before they make it into the organs: "ZEO absorbs the toxins from the alcohol before they are processed into your organs."

“FDA has urged Zeo Health to respond to its letter within 15 working days of receipt, advising the agency of the steps the company is taking to correct the violations. "Failure to do so may result in enforcement action without further notice." -”

3. FDA AER draft Guidance finally issued! Excerpts from the guidance:

“1. When do the requirements of the Dietary Supplement and Nonprescription Drug Consumer Protection Act become effective? -- The effective date for compliance with the requirements of this law is December 22, 2007.

2. What types of foods are covered by the Dietary Supplement and Nonprescription Drug Consumer Protection Act requirements? -- The requirements of this law only apply to dietary supplements. No other types of food are covered.

5. What is an "adverse event?" -- An "adverse event" is "any health-related event associated with the use of a dietary supplement that is adverse."

6. What is a "serious adverse event?" -- A "serious adverse event" is an adverse event that: Results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, or a congenital anomaly or birth defect; or requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described above.

7. What is a "serious adverse event report?" -- A "serious adverse event report" is a report that must be submitted to FDA on MedWatch Form 3500A when a manufacturer, packer, or distributor of a dietary supplement receives any report of a serious adverse event associated with the use of the dietary supplement in the United States.”

The AER Consultants web site, will be analyzing form 3500A and will be providing assistance for companies to comply.

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