To understand why Sen. John McCain introduced a bill on dietary supplements, read the press releases. The legislation announced Feb. 3  addresses public safety, but mostly it’s about the reputation and revenue of professional and Olympic sports.

The evidence: McCain says in the release that “a little over a year ago the NFL suspended six players, including two players from one of the teams competing this Sunday, for violating the league’s anti-doping policy.  Several of the players were surprised that they tested positive for a banned substance because they used a dietary supplement they believed to be safe and legal.”

McCain ends the release, “It is my hope that this legislation will ensure that all Americans, including athletes, have all the information necessary to make informed decision when choosing whether to use a dietary supplement, and that the FDA has the ability to remove any harmful dietary supplements from the market.”

What organization was first to endorse the legislation? Major League Baseball. Commissioner Bud Selig issued a statement supporting the bill and MLB.com reported on McCain’s announcement of the legislation.

Next on board: The U.S. Anti-Doping Agency, which issued a press release with an affiliated group, Supplement Safety Now. Its members include Major League Baseball, NFL, NBA, NHL, PGA, NCAA and other national sports organizations. All are powerful organizations inside and outside Washington. And they share a complaint: Their athletes have been unwitting victims of mislabeled supplements that caused disqualifications and suspensions.

In other words, the products were bad for business. The groups want to arm the FDA with the data to monitor supplements and the power to yank immediately the detrimental ones off the shelf. They found an ally in McCain, whose 2008 presidential campaign received substantial financial support from athletes and others in pro sports, ESPN reports.

The initial response from groups representing supplement makers and marketers was tepid. “Though we have not yet examined this bill completely, it places new burdens on dietary supplements that are not required for any other class of food,” Michael McGuffin, president of the American Herbal Products Association said the third paragraph of a press release.

The last sentence of the third paragraph of a press release from the Council for Responsible Nutrition quotes CEO Steve Mister as saying, “The best way to help consumers is through collaborative efforts with industry, government and other stakeholders, such as USADA, to implement the current laws, to provide more resources and funding to FDA, and to pass the food safety bill, which already includes many of these provisions.”

As the bill moves from the headlines to the sidelines, look for an intense lobbying effort by sports organizations. Supplement-related scandals have hurt their reputations and wallets. They see a solution in increased federal action and will push hard for that.

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On the topic of the FDA and regulation of dietary supplements, I am quoted as saying:

“The fear was a Democratic administration was going to be 180-degrees different…But the measures taken have not approached the sort of draconian response a lot of folks in the industry feared.  That’s not to say things didn’t tighten, they did.”

David Ettinger Food Law Expert

Also quoted is food law expert (and college chum) David Ettinger of Keller and Heckman in DC.

Unfortunately, the link requires a subscription, but a 30 day trial is available.  To read the full article, click here.

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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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Ric Hobby - VP Govt. & Industry Affairs, Herbalife Europe

Ric Hobby spoke at the CRN Conference last week on the state of international supplement regulation with a particular focus on European regulatory efforts.  Ric directed most of his talk on the work of the International Alliance of Dietary/Food Supplement Associations, of which CRN is a member.

The three European issues where IADSA has been most involved are:
* Maximum levels of vitamins and minerals
* Claims
* Botanicals
Ric referred to the “claims” issue as a “raving nightmare.”  The claims process requires review and approval for all claims by the European Foods Safety Authority.  Under the current process even “established” claims for supplements are being rejected by EFSA.

Ric also highlighted IADSA’s popular publications it produces and distributes including a very useful one entitled “The Scientific Substantiation of Health Claims” featured here.  You can download the guide by clicking on it.

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David Vladeck - FTC Director of Consumer Protection

David Vladeck, Director of the Federal Trade Commission Bureau of Consumer Protection spoke at the Council for Responsible Nutrition Conference on the FTC’s “active” dietary supplement enforcement agenda.

Dir. Vladeck began by highlighting recent FTC enforcement actions against bogus cancer cures, Airborne generics,  fake hoodia, and peddlers of H1N1 flu cures.  Vladeck noted that FTC has begun sending joint warning letters with FDA to marketers of bogus H1N1 flu products.

Vladeck had good words to say about the NAD as well. Though Vladeck observed that FTC did not always agree with NAD, which is a departure from the attitude taken by prior Consumer Protection Division directors.

Then Vladeck turned to the new FTC Endorsement Guides.  Everyone held their breath.

Before I go further it is important to remember that Vladeck comes from a consumer protection background.   He led the Public Citizen Litigation Group for 20+ years.

On the endorsement guides Vladeck’s message was clear:

1. Disclaimers like “results not typical” are useless and will be attacked by FTC.

2. Advertisers who make claims “will be held responsible for their claims.”

3. If your promotion relies only on testimonials “you will have a problem with us.”

Vladeck described this area for the FTC as a “target rich enviornment” in which they intend to pursue violators using all the resources at their disposal.  And when the 1000+ enforcement personnel at the FTC run out, FTC plans to call on the state attorneys’ general.  When the AG’s are too busy, Vladeck says that they will do as the FDA does and publish warning letters on the internet in order to “bully companies into compliance.”

Despite the backpeddling FTC has done in the media recently, Vladeck made it clear that he will enforce Section 5 of the Federal Trade Commission Act and the endorsement guides.  It was as if Vladeck was drawing imaginary targets on foreheads around the room…

I spoke to several attorneys and CEOs at the reception that evening about the regulatory problem the enforcement guides present and everyone agreed that the problem is very serious.  One observed, candidly, that the problem was that “you never know what marketing is doing until it is too late.”

After all, lawyers and regulatory execs are considered “sales killers.”  We are never consulted by marketing in advance of a promotion for fear we will put the kibosh on the latest profitable social media marketing strategy.

So what’s next from the FTC?  Who knows.  After all, it’s a “target rich environment.”

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FDA Deputy Commissioner Joshua Sharfstein, M.D.

FDA Principal Deputy Commissioner Joshua M. Sharfstein, M.D. gave the keynote speech to the Council for Responsible Nutrition Conference. Dr. Sharfstein expressed a willingness to work with supplement industry members and received a warm welcome from industry members in return.

Sharfstein filled in at the last minute when Commissioner Margaret Hamburg, M.D. was called before the Senate Committee on Health, Labor, Education and Pensions to testify at a hearing entitled “Keeping America’s Families Safe: Reforming the Food Safety System.”

Dr. Sharfstein started off by noting that FDA products account for $.20 of every $1.00 spent by Americans.  As to supplements, he revealed that he (like me) suffers from lactose intolerance and supplements with lactase enzyme.

Beyond the pleasantries, Sharfstein focused his speech on regulatory concerns with specific types of products and what FDA is doing currently to address these concerns.  Sharfstein pointed specifically to FDA successes in addressing products promoted for treating H1N1 flu, adulterated muscle enhancers containing anabolic steroids, and male enhancement supplements containing erectile dysfunction drug analogues.

Sharfstein also addressed suggestions that one way regulate adulterated supplements is through the NDI process.  Under DSHEA, ingredients that were in the food supply prior to October of 1994 are grandfathered in, but those that were not and require new dietary ingredient (NDI) applications.  However, as Sharfstein noted, there is no FDA recognized list of grandfathered supplement ingredients at present, and also many supplement products often contain undeclared ingredients which makes an approach that depends upon examining labels fundamentally flawed.  As a result, Sharfstein declared that new ingredient premarket verification is a priority for FDA.  With these and other challenges Sharfstein expressed a sincere willingness to work with industry to improve FDA response and regulatory strategies.

Sharfstein did receive several probing questions including a challenge regarding the FDA’s handling of the recent Hydroxycut recall, something we at NutriSupLaw have previously questioned several times.  The questioner noted that Hydroxycut was recalled based upon just 23 reports of liver disease out of over 20 million units of Hydroxycut sold, and asked Sharfstein for a the scientific basis of the FDA’s action.  The questioner also noted that the panel that raised concerns with Hydroxycut failed to identify a specific ingredient in the product that caused the problems, and there are many products still on the market today that contain those same ingredients.

To his credit, Sharfstein did not simply “toe the party line” on this issue in his response.  Instead he observed “I am getting the sense that there is a lack of understanding in this room about why the FDA did this,” and he went on to suggest that FDA reevaluate the matter and hold a conference call with industry to discuss it further.

Let’s see if FDA comes through and works with industry on these efforts.

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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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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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