Friday, April 10, 2009

04/10/09 - FTC Substantiation Questions

0.  News  -  Food Safety isn’t…
1.  FTC Questions about Substantiation
2.  Webinar Series Archives and Plans

0. VL Blog News – Codex and (sic) “Food Safety Bills” threaten nutrients

                                875… 425… 759… hike!

vitaminlawyerhealthfreedom.blogspot. com/2009/04/no-harmonization-against-our-health.html

[Please note: all URLs in this memo are "broken" with spaces inserted before the .com or .org to avoid the memo being treated as "spam" by AOL and other service providers.]


1. FTC Questions about Substantiation

One of the best ways to learn about how the agencies view the law and their power under it, is to read what they are saying in ongoing litigation. One such case wending its way through the FTC garnered the following claims against the company (the “respondents”) and its claims substantiation:

“Respondents Did Not Possess Substantiation For Such Claims At the Time They Were Made.

“Respondents conducted no scientific testing on any of the … Products

“Respondents have not conducted any double-blind studies on the … Products

“Respondents' have not conducted any controlled studies on any of the … Products

“No person has been involved in the scientific testing, research, substantiation, or clinical trials of the … Products

“Respondents have no documents relating to their policies, procedures, or requirements for evaluating or reviewing each safety, efficacy, or bioavailability representation made for the … Products

“It was not Respondents' practice to obtain scientific studies about any of the components in their Products

“Respondents did not search for scientific studies regarding the components in their Products…”

In effect, the above is a listing of what you need to do if you are attempting to meet the FTC standard – and what the agencies will say you have failed to do if they target your company.

The agency’s complaint counsel also stated what he believes to be the advertising standards the law requires FTC to follow:

“In implementing the "likely to mislead" standard, "the [FTC] examines the overall net impression of an advertisement] and engages in a three-part inquiry: (1) what claims are conveyed in the advertisement; (2) are those claims false or misleading; and (3) are those claims material to prospective consumers." Kraft, 970 F.2d at 314. The FTC may use its own reasoned analysis to determine what claims an advertisement conveys. See Kraft, 970 F.2d at 318 ("[i]n determining what claims are conveyed by a challenged advertisement, the [FTC] relies on ... its own viewing of the ad"); see also FTC v. Colgate-Palmolive Co., 380 U.S. 374, 385 (1965).   In determining whether an advertisement conveys a claim, the Commission looks to the overall, net impression created by the advertisement, through the interaction of different elements in the advertisement, rather than focusing on the individual elements in isolation. Stouffer Foods Corp.,118 F.T.C. 746, 799 (1994); Kraft, 114 F.T.C. 40 at 122 (1991); American Home Prods. Corp. v. FTC, 695 F.2d 681, 688 (3d Cir. 1982); FTC Policy Statement on Deception, 103 F.T.C. 174, 179 (1984) (appended to Cliffdale Assocs.) (emphasizing importance of considering "the entire mosaic, rather than each tile separately").

“Features of an advertisement such as a product name, visual images, and the use of testimonials may imply claims. Jacob Siegel v. FTC, 327 U.S. 608, 609 (1946); Kraft, 114 F.T.C. at 322; Thompson Medical, 104 F.T.C. at 793 and 811-12; Porter & Dietsch, Inc. v. FTC, 605 F.2d 294, 301, 303 (7th Cir. 1979).

“To determine how "reasonable consumers" interpret a claim, the Commission considers the target market for the advertisement. When the target market consists of "desperate consumers with terminal illnesses," the FTC has shown particular care in evaluating deceptive acts or practices. FTC v. Travel King, Inc., 86 F.T.C. 715 (1975).

“Advertising claims may be express or implied. Kraft, 970 F.2d at 318. Express claims
directly state the representation at issue, while implied claims make representations
without direct statements. Id. at 318 and 319 n.4; Thompson Medical, 104 F.T.C. at 788-
89. The courts and the FTC have recognized consistently that implied claims fall along a
continuum, from those which are so conspicuous as to be virtually synonymous with
express claims, to those which are barely discernible. See, e.g., Kraft, 970 F.2d at 319; FTC v. Febre, No. 94 C 3625, 1996 WL 396117, at *4 (N.D. 111. July 2, 1996) (magistrate judge recommendation), adopted by 1996 WL 556957 (N.D. m. Sept. 25, 1996), off d, 128 F.3d 530 (7th Cir. 1997); see also Bronson Partners, 564 F. Supp. at 127-28 (an advertisement's statements were "so clear, repetitive, and unambiguous that they constituted] the functional equivalent of express claims")…”

From this language, you can see that you need to be very careful about what you claim “by implication” as well as what you claim in plain language. When I advise clients regarding claims and claims substantiation, I keep in mind the expansive view of its authority that the FTC advocates in cases that reach the stage of litigation. The object is, however, to be careful enough with language that issues such as these never rise to the level of agency concern. That means you need to review each piece of new copy you use to make sure that in context it will not be seen to create an implication of claims that are not “truthful and not misleading.” I’m here to help make that happen.


2. Natural Solutions Vital Connection Webinars with The Vitamin Lawyer

A. Bringing New Natural Products to Market

Date: To Be Provided (late April or early May)
Time: 8:00 PM EDT (approximately 2 hours)

What does it take to bring a new natural product to market? This webinar will cover the pitfalls and requirements. Especially in the current market, you need to do everything right to have a success… includes a useful eBook and a private forum for additional communications.

The sign-up link will be posted in mid April at: www. healthfreedomusa. org/?page_id=2002

In the meantime, you can email me at with “Webinar” in the subject line to reserve your place.

"Your papers must be in order."

Are your ingredients "grandfathered" under DSHEA?
Have you filed your Structure and Function Claims Notices?
Do you have your SOPs (Standard Operating Procedures)
Is your web site Site Use Statement up-to-date?
Is your Substantiation Notebook ready?

Your papers need to be in order before the FDA inspection!

B. CAM Advanced Healthcare Practitioner SOPs

Date: 02/26/09 [This Webinar has been archived and is available to view.]
Time: 8:00 PM EST (approximately 2 hours)

You can see the archived webinar at:
vital-connection. com/ethical-legal-considerations-course-february-26th-2009/

You can see my short introductory YouTube video at:
vitaminlawyerhealthfreedom.blogspot. com/2009/02/webinar-announcement-ethical-legal.html

All Webinars include useful eBooks of forms and other information that will help you bettr organize.


Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com