Vitamin Lawyer Update Memo: April 25, 2008
This issue:
1. FDA to Require Data on Substantiation – Seeks Comments
2. FTC Unapproved Medical Claims Tactic: “Disgorgement”
3. Are Your SOPs in Order? AER SOP Available
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1. FDA to Require Data on Substantiation – Seeks Comments
FDA is moving to upgrade the enforcement of the Claims Notice requirements by setting up a system to collect data on substantiation (heretofore, you had to have the data “on file” – now FDA seeks to collect that data.
“To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974, or e-mailed to baguilaz@omb.eop.gov. All comments should be identified with the OMB control number 0910-NEW and title, "Draft Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act." Also include the FDA docket number found in brackets in the heading of this document. [Docket No. FDA-2008-D-00301 - formerly Docket No. 2004D-0466]…
“Dietary supplement manufacturers will only need to collect information to substantiate their product's nutritional deficiency, structure/function, or general well-being claim if they chose to place a claim on their product's label. Gathering evidence on their product's claim is a one time burden; they collect the necessary substantiating information for their product as required by section 403(r)(6) of the act…
“The standard discussed in the draft guidance for substantiation of a claim on the labeling of a dietary supplement is consistent with standards set by the Federal Trade Commission for dietary supplements and other health related products that the claim be based on competent and reliable scientific evidence. This evidence standard is broad enough that some dietary supplement manufacturers may only need to collect peer-reviewed scientific journal articles to substantiate their claims; other dietary supplement manufacturers whose products have properties that are less well documented may have to conduct studies to build a body of evidence to support their claims. It is unlikely that a dietary supplement manufacturer will attempt to make a claim when the cost of obtaining the evidence to support the claim outweighs the benefits of having the claim on the product's label. It is likely that manufacturers will seek substantiation for their claims in the scientific literature…
“FDA assumes that it will take 44 hours to assemble information needed to substantiate a claim on a particular dietary supplement when the claim is widely known and established… FDA believes it will take closer to 120 hours to assemble supporting scientific information when the claim is novel or when the claim is pre-existing but the scientific underpinnings of the claim are not widely established. These are claims that may be based on emerging science, where conducting literature searches and understanding the literature takes time. It is also possible that references for claims made for some dietary ingredients or dietary supplements may primarily be found in foreign journals…”
fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0030-n.pdf
Please note the new data production requirements are not yet in effect and I will let my list know as this develops further.
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2. FTC Unapproved Medical Claims Tactic: “Disgorgement”
FTC has been pursuing what is usually a criminal law tactic in its civil complaints against nutrient purveyors who make “medical claims” by demanding that the offender “disgorge” all of its gross sales income from such claims to the FTC, for, as stated in a Stipulation of Settlement offered one company earlier this month, “All funds paid pursuant to this Order shall be deposited into a fund administered by the Commission or its agents to be used for equitable relief , including but not limited to restitution, and any attendant expenses for the administration of such equitable relief. In the event that direct redress of consumer injury is wholly or partially impracticable or funds remain after the restitution is completed, the Commission may apply any remaining funds roe such other equitable relief (including consumer information remedies) as it determines…”
Conclusion: if you make unapproved medical claims, ALL the money that comes into your company from those claims will be taken by the government. You need to review and revise any such claims… contact me if you need my help.
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3. Are your Papers in order? AER SOPs
The Vitamin Lawyer .com Consultancy retainer clients have received updated versions of Standard Operating Procedures detailing procedures for Adverse Event Reporting (AER) and other changes.
If you would like a copy of the AER SOP, just send me an email with AER in the subject line and I’ll send you a copy… with my compliments.
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Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
