Marketers of nutritional supplements often complain that they do not know what the FDA wants. Even after the agency sends a warning letter about misleading claims and advertising, its staff does not explain what would fall within the rules. That’s the reality; the FDA will tell you what’s wrong, not what’s right.

Through warning letters, the agency provides insight into how a marketer can fall afoul of the rules. Companies that examine why their competitors get chastised can apply the lessons to their Web sites, catalogs, labels and the like.  Washington attorney Ivan Wasserman looked at the 73 letters issued in 2009 (way, way up from 44 in 2008) and found that 72 related to claims on Web sites. Six involved claims made in metatags.

Lesson #1: The FDA is surfing the Web, checking not just product descriptions and benefits, but Googling for questionable SEO/SEM.

Wasserman’s list would rank the letters by claim problems in this order:

• Drug and disease claims: 72
• H1N1 virus claims: 37
• Other drug and disease claims: 20
• Heart disease and cardiovascular claims: 11
• Diabetes claims: 8
• Cold and flu claims (not H1N1): 8
• Cancer claims: 8

Lesson #2: The medical emergency that makes the most headlines gets the greatest scrutiny. In 2009, that was H1N1.

The FDA also sent 12 warnings letters related to claims made on labels and product labeling. Some of these may have echoed what was published on Web sites as manufacturers compounded their marketing errors.

Lesson#3: The FDA reads labels in the stores and on packages sent by mail. Adding an asterisked disclaimer to language on a label is no protection.

The FDA lived up to its announced commitment of greater enforcement and more scrutiny of the supplement industry. The agency could top the century mark in warning letters this year. Companies that have not recently reviewed their sites and labels would be wise to do so now before the mail carrier brings bad news.

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Ever since receiving FDA notices about their advertising generated from Google and similar searches, drugmakers have toned down their language and sought clarity on what is allowed. The discussion has ramifications for makers of nutritional supplements, because they could be next to face agency scrutiny for every ad created in response to a search for acai, reseveratrol and the like.

On Nov. 12, drugmakers and search-engine advertising agencies participated in about 30 presentations before the FDA. The hearing room was so crowded that most people seeking an audience seat were turned away. Here are two media takes:

(Yahoo’s David) Zinman testified that this shift to generic ads that don’t mention a brand name has created “a world where users have less transparency” because the ads deprive searchers of critical information about the landing pages. (MediaPost)

“We don’t think companies should be responsible for policing the entire Internet for information about their products,” said Johnson & Johnson executive Elizabeth Forminard.  (Reuters)

The key word is transparency, but Yahoo’s Zinman has it backwards. The FDA’s criticism was based on a lack of transparency in the form of who could take the drugs and what warnings should consumers receive before they clicked on the link. The FDA sent the warning letters because there was not enough information in the search-generated ads.

Forminard should walk down to FTC offices and read the new rules on Web marketing that take effect on Dec. 1; J&J will be responsible for a significant portion of what is posted on the Internet about its products.

There is more testimony today (Nov. 13) and the FDA will continue listening through February 2010. Nutritional supplement makers should watch for when they get dragged into the discussion. We all know that some vitamins are contraindicated for some people; will that fact have to be disclosed in your Google ad?

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New Rules: Endorsements & Testimonials in Marketing (The Business of Marketing)

“Those were the days – the days when a marketer could use an actual quote from a real person that has used your product as a marketing endorsement or testimonial to capture the aspirations of your potential customers. As of December 1, 2009, those days are gone.”

What You Need to Know About the New FTC Endorsement Rules — and Why (Ad Age)

“Revlon won’t be able to give away its product to mommy bloggers without asking them to disclose it in their writings. And if Jennifer Love Hewitt claims her blemish-free skin is the result of Proactiv, she had better be telling the truth.”

FTC Wants To Clarify: Bloggers Probably Won’t Get Dinged $11,000 (Washington Post)

“…the FTC would most likely send an [sic] warning letter to a blogger who pitches for Jiffy but doesn’t disclose receiving funds from Virginia peanut farmers.”

Do the FTC’s New Endorsement/Testimonial Rules Violate 47 USC 230? (Technology & Marketing Law blog)

“…the FTC apparently has made the same analytical error that the SEC recently made in the SEC’s proposal to hold securities issuers liable for third party content they link to.”

FTC Orders More Disclosure in Consumer Testimonials, Celebrity Endorsements (National Law Journal)

“(Attorney Anthony DiResta is) not as positively inclined toward the decision to do away with the “results may vary” disclaimer in favor of describing typical results. “Whenever there is going to be a claim of typicality, then there’s going to have to be substantiation.” And that can be costly and timely, DiResta added.”

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If your marketing plan includes raising awareness through bloggers, read the latest FTC announcement on disclosure of freebies. The agency says that bloggers who review products given to them for free should disclose that fact in some circumstances. Failure to do so will not affect the bloggers, but could trigger FTC action against marketers for what the agency considers deceptive practices. The good news: Chats and other unprepared communications among consumers are not considered corporate marketing. Read the entire notice, which goes into effect Dec. 1, here.

Given the unruliness of the Web, many companies have wondered whether solicited and unsolicited product reviews constituted marketing and advertising. For reviews by news media, the answer is no, the FTC says. For bloggers, the answer is maybe. Much depends on the nature of the blog, the FTC says. For example, what is the blog’s readership? Does the blogger disclose the product’s value? Does the blogger accept requests to product reviews on a regular basis?

More to the point, the FTC says, “the post of a blogger who receives cash or in-kind payment to review a product is considered an endorsement. Thus, bloggers who make an endorsement must disclose the material connections they share with the seller of the product or service.”

The FTC says it will examine each instance separately, which means for marketers more incremental understanding than firm rules at the outset. Expect the rules to change as the distinction between members of traditional news media and bloggers continues to erode. For now, the FTC expects companies that send samples and ask for reviews to tell the blogger that he or she should that they received the items gratis. The company must also monitor the blog to see that disclosure is made.

A company does not have to keep an eye on people who buy a supplement and write about whether they liked it. Nor does a company have to monitor the comments on that review. None of that is considered a product endorsement.

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What has not changed since our first blog on Aug. 2, 2005, is our mission. So it is worth republishing the first entry by our founder, Joel Rothman. For those of you who were not present for the launch, here is the original post:

Welcome friends to the first legal weblog devoted entirely to the nutritional supplement industry. This first post will give you the what and why of this blog, as in what I am going to write about here and why I am writing it. For more information on who I am, click the “About” link on this page.

Okay, what is this blog about? It’s about all forms of nutritional and dietary supplements, vitamins, neutraceuticals and cosmeceuticals, the laws that regulate them, and court cases concerning those laws. It’s about laws regulating supplement safety, advertising and sales. It’s about lawsuits brought by those claiming to have been injured by supplements, and lawsuits brought by and against companies in the supplement business. It’s about the claims dietary supplement manufacturers make in big bold letters on the front of the box, and the disclaimers in tiny letters on the back of the box. It’s about other things too that strike my fancy. So that’s the what.

The why is pretty simple. From time to time I represent nutritional supplement manufacturers. In the past I have found it difficult to get current, topical and useful information about the laws and cases that matter to my clients. Other lawyers I know have also told me that there is really no place to go on the web that addresses legal matters of concern to this young and growing industry. So, I hope to provide some measure of assistance to those like me looking for a resource like this.

Now, a word about what this blog is not. Since I have already said that I have clients in the business, you might have figured out that this blog is not a place to find a lawyer to sue supplement manufacturers because you think you got sick or hurt from taking dietary supplements or using cosmeceuticals. There are lots of lawyers out there who I am sure will listen to you and they are easy enough to find. This is also not a blog that rails against nutritional supplements and the people who make them. This is not a blog about the pros and cons, this is a blog about the legal environment in which nutritional supplements are made and sold. If you have something to say about what is good or bad about a particular pill, creme or protein shake, we are interested only if there are legal implications to it. This blog is also not legal advice, so don’t use it as such and we disclaim any liability to you and yours should you disregard this warning.

So there you have the what and the why. Again, the who is linked on the sidebar. Now, let’s get busy with some content!

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The statement also reads: “Products like these are frequently marketed as alternatives to anabolic steroids for increasing muscle mass and strength and are sold both online and in retail stores.  They are often promoted to athletes to improve sports performance and to aid in recovery from training and sporting events.  Although products containing synthetic steroids are frequently marketed as dietary supplements, they are NOT dietary supplements, but instead are unapproved new drugs that have not been reviewed by the FDA for safety and effectiveness.”

The Council for Responsible Nutrition sent out an alert immediately following the FDA announcement, with phone numbers (866-359-3719 U.S. and 203-369-0144 international) for anyone to call and listen to a recording of the conference.

The seriousness of the FDA warning, coupled with heighten media exposure of the dangers that high school athletes face from taking steroids, may lead to action by regulators, sports associations and others. The heightened public awareness will likely lead to more consumer questions.

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Cathy

If you thought faux news was the province of only The Daily Show, The Colbert Report and The Onion, welcome to News 13 WKTV. It is the non-TV station,  non-news Web site that reports on Resveratrol Ultra. And it is not the only fake station. Move up the Internet dial and you will find News 29 Online. There, a reporter named Alice Avaleece uses almost the exact same language to tout Acai Essence as fake-WKTV’s Cathy Diaz does to describe Resveratrol Ultra:

“Usually as a reporter I find products that are “too good to be true” and report on how they didn’t live up to their claims. I can say with the utmost certainty that this is a feel good story for the “ages”!”

Alice

Suspicious? So are the people at the real WKTV, which operates Channel 2 in Rochester, N.Y. They might be interested to know that Ms. Diaz also appears on another URL, http://abc360news.com. Look closely at the faux-anchors atop the Web pages of both faux stations and you might see the same face twice. You will definitely notice that the stories on the pages have only minor differences; for example, Cathy in New York is 35 and Alice in Florida is 33 .

The two fake TV Web sites share product links to Resveratrol Ultra. The site has more product information and this disclaimer: “Resveratrol Ultra is not affiliated in any way with CNN, FOX, WebMD, ABC, FORTUNE, NBC or CNN.”

Who owns the two Web sites? News 13 is a mystery, but a “Who Is” search of News 29 shows that the registrant is XM Brands and the administrative contact is Issa Asad. Both have an address of 3609 N. 29th Ave., Hollywood, Florida. There the trail gets confusing. Acai Essence is sold by a company in the West Indies and Resveratrol Ultra by a company in Cyprus.

Search Google for “XM Brands” and the first page of results has a number of uncomplimentary entries, including an “F” rating dated October 2008 from the Better Business Bureau of Southeast Florida and the Caribbean.  Search for “Issa Asad” and “acai” and you can find Acai XM, where the same “Dr. Perricone” who pronounces the benefits of Acai Essence also recommends Acai XM.

As they say in the TV news business, “Stay tuned.”

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The FTC also announced a new Web site about bogus cancer cures. The site – www.ftc.gov/curious – tells consumers how to spot and report bogus claims they see online, and urges people with cancer to talk to their treatment team about any products they’d like to try.
The site features a video and includes a list of resources on cancer treatments from a variety of agencies within the federal government. Information is provided in English and Spanish.

The cases announced today began through an Internet surf conducted by the FTC, the U.S. Food and Drug Administration (FDA), and Competition Bureau Canada in June 2007. Following the surf, the FTC sent warning letters via e-mail to 112 Web sites between August 2007 and January 2008. Of these, nearly 30 percent either closed their sites or removed the problematic cancer treatment claims. The remainder were reviewed to determine whether a law enforcement action was warranted or whether they should be referred to the FDA or the Competition Bureau.

To read the press release, click here.

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