Jin Hua Qing Gan Fang made in lab.

The rules are different here in the United States. Hyde Park Holistic Center in Cincinnati recently received a warning letter from the Food & Drug Administration that read like many others having to do with nutritional supplements and the H1N1 virus. In China, though, the same admonishment could not be heard.

First, the FDA’s message to Hyde Park, which operates the Web site drdahlman.com: “The FDA has determined that your website offers a product for sale that is intended to diagnose, mitigate, prevent, treat or cure the H1N1 Flu Virus in people. This product has not been approved, cleared, or otherwise authorized by FDA for use in the diagnosis, mitigation. prevention, treatment, or cure of the H1N1 Flu Virus.”

The product in question is “4 Life Transfer Factor Plus Tri Factor,” which is sold in a password-protected store on the site. The product apparently supports immune system health or, as the FDA quotes Dr. Dahlman on one of his Web pages, “I firmly believe that use of this product will sufficiently upregulate your immune system and should be a primary part of your strategy to avoid the dangers of swine flu (H1N1 virus).”

It’s worth noting that Dr. Dahlman is not an M.D. His online biography says he is “a Chiropractic Physician with a degree in Nutrition, is Director of The Hyde Park Holistic Center in Cincinnati, Ohio and specializes in treatment of chronic health problems using nutritional, herbal and homeopathic therapies.”

If Dr. Dahlman were in China, he might have gotten praise rather than criticism. On Dec. 16, Chinese medical specialists said they had developed a Chinese herbal medication to treat H1N1. An article from the official Chinese news agency, Xinhua, quotes Wang Chen, president of Beijing’s Chaoyang Hospital, as saying the medication “can shorten patients’ fever period and improve their respiratory systems. Doctors have found no negative effects on patients who were treated in this way.”

The article adds that the herbal formula, called “Jin Hua Qing Gan Fang,” had been tested at 11 hospitals on 410 people who exhibited mild symptoms of H1N1. With success in treatment over a five-month period, the makers were seeking international patents.

The herbal medication is being positioned as a lower-cost alternative to Tamiflu, which WHO recommends for the treatment of H1N1.
Interestingly, the article quotes Cris Tunon, a senior officer at the WHO office in China, as saying that “WHO welcomes the clinical results.”

It’s unlikely the herbal medication would get the same greeting in the United States. The FDA has warned a number of companies with herbal products to stop making H1N1-related claims. Twice in 2009, the AHPA has advised against the use of dietary supplements to prevent or treat the flu. What happens when “Jin Hua” is marketed on American shores?

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David Frum

David Frum recently laid into the nutritional supplement industry with a guest commentary on CNN.com. The resident fellow at the American Enterprise Institute and one-time special assistant to President George W. Bush lashed out with the classic invectives against supplement makers and marketers. He wrote that any “snake oil flim-flam can be huckstered in the most truth-defying way” using that most evil of laws, the Dietary Supplement Health and Education Act of 1994.

Frum could have lowered his rhetorical blood pressure, without the help of a supplement, by reading the FTC regulations that go into effect on Tuesday. His column then would have begun: The party is over Dec. 1.

And the party — or at least marketing as it has been done for many years — does come to an end. Frum’s arguments against vague product claims no longer hold when the FTC — not the FDA — is watching what is said. The effects of the new rules are worth noting again: no more CYA disclaimers such as “results not typical” language; closer scrutiny of expert and celebrity endorsements; and careful review of consumer testimonials.

All the people who try a supplement and blog about it or are paid to write online reviews also have to disclose their relationships with those who supply them with products.

Frum can argue for repeal of the DHSEA, but he would be better off passing along tips of deceptive advertising to contacts he has at the FTC. That would produce more effective results than spouting off about his distaste for the supplement industry and its marketing practices.

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As we have written before, makers of nutritional supplements should pay close attention to comments submitted to the FDA before February 2010. There will likely be advocates for warnings on all products that make a claim to support good health. The agency’s rules on search-based advertising for health products could encompass non-prescription items such as vitamins and muscle-building powders.

The ruckus in Washington on Nov. 12 and 13 stemmed from FDA warnings in March to drug makers that their search-based ads did not contain proper product warnings. Drug makers backed off their advertising, and the search-engine companies saw revenues plunge. Everyone hurried to Washington to ask the FDA for clarification.

Google presented a solution. It told the agency that sponsored links are now less transparent and relevant. Google then proposed a standard for product-claim sponsored links:

1. A headline that links to a product landing or home page.
2. A first line with the Web address for that page, followed by an information message.
3. A second line containing a safety warning that cannot be altered, followed by a link to a Web page with more details on the warning.

You can see sample Web pages by Google at Scribd. Other companies and public advocacy groups will likely have ideas on how to balance sales messages and product warnings. There may be software solutions such as pop-ups or Flash that could be integrated in order to present more information in an ad, but an elegant solution seems unlikely. Thus, the FDA could write rules that force makers and marketers of nutritional supplements to alter their sponsored links in ways they never wanted.

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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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Should there be a language standard in Google ads for supplements? Drug marketers may adopt rules given the close scrutiny that the FDA is giving search-generated ads for pharmaceuticals. The Interactive Advertising Bureau is asking the feds to endorse the use of standard formats online for drugs.

Why? Because seemingly harmless statements are incurring the FDA’s wrath. Case in point: A search for the pain medication Fentora generated this sponsored message from its maker, Cephalon: “Learn about treating breakthrough pain in patients with cancer.”

Harmless, right? No, said the FDA. According to a MediaPost report, the FDA deemed “such ad copy was deficient because it implied that all cancer patients with breakthrough pain could use Fentora.” The agency also said that the “implication was misleading because the drug is only indicated for people who can already tolerate around-the-click opioid therapy.”

The FDA warned a host of the world’s largest drugmakers that they too were running misleading ads. Unsure of how to act, the companies cut back on search-generated ads, with volume falling by about half. Now, the IAB wants a set of clear rules so that the drugmakers can resume online advertising without getting into trouble.

Standards may also help marketers of nutritional supplements. While drugmakers have a higher standard for publishing warnings and limitations on their products (see any Cialis ad), makers and marketers of nutraceuticals operate at their peril in making claims for ingredients. And sponsored links on Google could be one place they find trouble.

For example, a search on antioxidant produced this language in a sponsored link:

Get Healthy w/Natural Antioxidants
One Year Money Back Guarantee!”

Similarly, a search on glucosamine chondritin produced this ad language:

Drink Joint Juice and Leap More.
The 30-Day Joint Health Challenge!

How would the FDA or FTC view these claims getting healthy or jumping higher if they were made for drugs? The supplement industry may want an answer before agencies go on the offensive.

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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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Let us start by apologizing to the Bard and my 8th grade English teacher for the headline. It’s a good way to ask the question of how closely nutritional supplement companies can connect with the fast-moving world of social media. Should you Tweet about a new ingredient? What happens when an unidentified person posts that your product cured his illness? What if a customer posts online — with photos — evidence of an adverse reaction to your product?

The FDA will address these questions at a hearing Nov. 12-13 in Washington. The agency is soliciting comments in the Federal Register “to help guide FDA in making policy decisions on the promotion of human and animal prescription drugs and biologics and medical devices using the Internet and social media tools.”

Good luck, regulators. The techies who created Twitter, Facebook and their ilk cannot keep pace with technological and user-driven changes. That’s what happens when you put control in the hands of the people.

There is no crowdsourcing at the FDA, but the agency uses Twitter to release news on drugs and medical devices, and to announce recalls. Clearly, someone inside the FDA has a teenage son or daughter.

The FDA now recognizes that it is playing catch-up and writes in the Federal Registry that “special characteristics of Web 2.0 and other emerging technologies may require the agency to provide additional guidance to the industry on how the regulations should be applied.”

May require additional guidance? The agency must know that social media are spreading from computers to cell phones. The FDA’s alternative to writing rules is to dole them out through warning letters and the like. Guidelines would benefit everyone. The Federal Register is so last century, though. How about a Fan Page for suggestions?

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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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According to the FTC’s complaint, the defendants, operating through their umbrella company Ultralife Fitness, Inc., lured customers by promising to send, for a specified trial period, free samples of the dietary supplement Hoodia, which they claimed caused weight loss. The supplement was purportedly derived from the cactus-like Hoodia gordonii plant, which is found in southern Africa.

To read the press release, click here

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