04/25/08 - FTc and FDA Tactics to Limit Healthcare Free Speech

 

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 All comments should be identified with the OMB control number 0910-NEW and title, "Draft Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act."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“The standard discussed in the draft guidance for substantiation of a claim on the labeling of a dietary supplement is consistent with standards set by the Federal Trade Commission for dietary supplements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

01/12/06 - New Law Threatens Internet Communications - Disclaimer

01/12/06 - VITAMIN LAWYER UPDATE e-MEMO

On January 5th the US president signed another complex and confusing law that has a serious threat to Internet communications buried in it.

The law is The Violence Against Women and Justice Department Reorganization Act, and the relevant section is 113. It states:

"Whoever...utilizes any device or software that can be used to originate telecommunications or other types of communications that are transmitted, in whole or in part, by the Internet... without disclosing his identity and with intent to annoy, abuse, threaten, or harass any person...who receives the communications...shall be fined under title 18 or imprisoned not more than two years, or both."

It is my opinion that this restriction will most likely not stand up against constitutional scrutiny. There is law backing anonymous political statements, reviewed by Justice Thomas in '95 - http://straylight.law.cornell.edu/supct/html/93-986.ZC1.html

"After reviewing the weight of the historical evidence, it seems that the Framers understood the First Amendment to protect an author's right to express his thoughts on political candidates or issues in an anonymous fashion."

I'm sending this alert out so that people are aware of this new law and can more carefully express themselves. For example, if you were to post an anonymous comment about, say, some company CEO, you might want to include some sort of disclaimer, such as "This statement is being made to express my opinions and understanding of the truth in the matter; it is not intended to annoy, abuse, threaten, or harass any person."

I still don't understand why Congress doesn't get it -- the First Amendment states explicitly "Congress shall make no law..." abridging freedom of speech -- "no law" means just that: NO LAW.

Here is a cogent comment I received from a knowledgeable source:

“It turns out that the statute can only be used when prohibiting the speech would not violate the First Amendment. If speech is protected by the First Amendment, the statute is unconstitutional as applied and the indictment must be dismissed. An example of this is United States v. Popa, 187 F.3d 672 (D.C. Cir. 1999). In Popa, the defendant called the U.S. Attorney for D.C on the telephone several times, and each time would hurl insults at the U.S. Attorney without identifying himself. He was charged under 47 U.S.C. 223(a)(1)(C), and raised a First Amendment defense. Writing for a unanimous panel, Judge Ginsburg reversed the conviction: punishing the speech violated the Supreme Court's First Amendment test in United States v. O'Brien, 391 U.S. 367 (1968), he reasoned, such that the statute was unconstitutional as applied to those facts.”