In a statement, commission chairman Jon Leibowitz said, “We expect more from a great American company than making dubious claims – not once, but twice – that its cereals improve children’s health. Next time, Kellogg needs to stop and think twice about the claims it’s making before rolling out a new ad campaign, so parents can make the best choices for their children.”

In a joint statement, Leibowitz and commissioner Julie  Brill used stronger language: “As a trusted, long-established company with a presence in millions of American homes, Kellogg must not shirk its responsibility to do the right thing when it advertises the food we feed our children.”

Kellog had a run-in with the FTC over its Frosted Mini-Wheats that resulted in the company’s admission that health claims made for the cereal were false and a settlement order in February 2009. Kellogg agreed not to claim “benefits to cognitive health, process, or function provided by any cereal or any morning food or snack food unless the claims were true and substantiated,” according to the statement on the Rice Krispies order.

Leibowitz and Brill said in their joint statement that even as Kellogg was pulling back on the Mini-Wheats claims, it must have been moving forward with health claims on the Krispies cereals.

“The company clearly has the means and ability to carefully test its children’s food products to determine if the products in fact provide health benefits for kids,” the commissioners said. “We are also confident that Kellogg has the wherewithal to carefully develop truthful and nonmisleading advertising about such health benefits.”

Kellogg responded with a statement saying that it stands behind the validity of product claims and research. “So we agreed to an order that covers those claims,” their statement said.

The expanded order now prohibits Kellogg from “making claims about any health benefit of any food unless the claims are backed by scientific evidence and not misleading.”

This is familiar ground for makers of nutritional supplements, but not so much for a manufacturer whose advertising icons include three guys in hats and a cuckoo bird. (Cocoa Puffs had the claim, too.) Kellogg, and General Mills whose Cheerios heart-health claims drew a warning letter from the Federal Drug Administration, are now learning what it’s like when you emblazon words like “immunity” and “antioxidants” on product packaging.

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The Feds are again looking at how companies market foods to kids. Concerned by reports on child obesity, the FTC in 2010 will take a look at what the food companies sell for kids and how those products are marketed. Makers of healthful foods would be wise to contribute to the testimony in advance of possible congressional action that could give their products a competitive advantage.

David C. Vladeck, director of the FTC’s consumer protection bureau, told the Wall Street Journal that the proposals would not be regulations and that Congress may ultimately write the new rules.The Journal says the recommendations will be sent to Congress after a public comment period.

The food industry seems to be taking the possibility of legislation seriously. General Mills has announced plans to reduce sugar content in three cereals, Trix, Cocoa Puffs, and Lucky Charms. Campbell Soup Co. says it will cut the amount of sodium in canned SpaghettiOs by up to 35 percent.

That begins to address one-half of the equation. University of Arizona professor Dale Kunkel has found in a study that children would have to watch 10 hours of television aimed at audiences 11 years and younger to see one commercial for healthful food. During that time, they would see 55 commercials for junk food. He took the results of his study to Washington and testified before the FTC on Dec. 15.

After the study was released, Sen. Tom Harkin, D-Iowa, expressed disappointment in the food industry’s efforts to self-regulate.

“When private interests work against the public good, government is obliged to act,” he said in a statement. “We need to examine this issue more closely and figure what needs to be done to achieve balance on the airwaves so that we can improve the health and wellness of our children.”

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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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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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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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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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Lesson #1: Do not copy someone else’s advertising. Just because the other companies make product claims does not mean it is OK. The FTC might penalize all of you. The FTC settled with Airborne for $30 million in August 2008 and with Rite-Aid, seller of Germ Defense, in July for $500,000.

Lesson #2: Have product claims reviewed before you advertise. The FTC said in a press release that it had charged CVS with “making false and deceptive advertising claims that using its product would reduce the risk of colds and protect against catching colds in crowded places, such as schools, airplanes, offices, health clubs, theaters, or restaurants.” The FTC said that “the company had no evidence that the products could boost the immune system or prevent colds.”

Lesson #3: The FTC is cracking down on supplement advertising. “With orders against Airborne, Rite Aid, and the one proposed against CVS, manufacturers and retailers are on notice that they have to tell the truth about what dietary supplements can and cannot do,” the FTC said in its release on the CVS settlement.

Lesson #4: Do not stretch the truth. The FTC is taking a highly critical view of product claims and scientific evidence. The agency has sued Rite Aid’s supplier of Germ Defense, Improvita Health Products Inc., claiming that company with deceptive acts or practices and with making false advertisements.

Lesson #5: Avoid the flu — and advertising related to it. This fall, the public faces the dual threat of seasonal flu and the H1N1 virus. A company that advertises a defense against either is likely to receive a call from the FTC.

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Jonathan W. Emord, Esq.

Supplement lawyer Jonathan Emord has filed three important suits this summer challenging FDA administrative action on first amendment grounds.  The suits were all filed on behalf of long-time Emord clients Durk Pearson, Sandy Shaw, the Alliance for Natural Health, and the Coalition to End FDA and FTC Censorship.

The complaints in all three cases were filed in federal district court for the District of Columbia and are captioned identically.  The first suit challenges the FDA’s rejection of qualified health claims for supplements containing the powerful antioxidant and anti-carcinogenic selenium (the “Selenium Challenge”).¹  A second suit challenges the FDA’s rejection of qualified health claims for antioxidant vitamins C and E (the “C and E Challenge”).² The third suit challenges the FDA’s dietary supplement current Good Manufacturing Practice regulations (the “cGMP Challenge”).³

These plaintiffs and their lawyer are well known for making law in the Pearson/Whitaker Cases that has benefitted the supplement industry significantly over the past ten years.⁴. Since the court decisions that may emerge from the new Selenium Challenge, C and E Challenge, and cGMP Challenge cases could have a significant impact on the law regulating supplement formulators, manufacturers, and marketers, and the FDA’s interpretations of that law, we are providing more expanded coverage here of these potentially important cases.  Part I will address the Selenium Challenge and the Vitamins C and E Challenge, and Part II will follow in a separate blog post to address the cGMP Challenge.

The Selenium Challenge and the Vitamin C and E Challenge – Does the FDA disregard the law and Supreme Court precedent by suppressing commercial speech about supplements?

For anyone not acquainted with the herculean legal struggle undertaken by Emord and his clients in the Pearson/Whitaker series of cases, the Complaint in the Selenium Challenge is a worthwhile read and I commend you to it.  The point of all the billable hours invested in this struggle may seem elusive but is actually quite simple: force the government to limit its censorship of claims about supplements to the “least restrictive means” test articulated again and again by the US Supreme Court in commercial speech cases.⁵

What does this mean from a practical standpoint for supplement companies?  It means that if you have a claim to make about your ingredient or formulation, and that claim is supported by competent and substantial scientific evidence, you should be allowed to make that claim as long as the claim is not deceptive or misleading. Sounds simple, right?  Sounds like the good practice you are already following for structure-function claims, right?

Well, what if that claim is a disease claim, like a claim that says “take this supplement and you may be able to prevent yourself from cancer.”   That’s not a DSHEA structure-function claim.  On the contrary, that’s the holy grail of supplement marketing, a claim that the FDA would say makes your product an unapproved drug and subjects you to prosecution for violation of the Food, Drug and Cosmetics Act.

Emord’s victories in the Pearson/Whitaker Cases paved the way for such claims, and required the FDA to create a new category of claims called “Qualified Health Claims.”  Qualified Health Claims are claims with disclaimers that provide a balanced view of the scientific evidence available to support a particular supplement’s impact on a specific disease state by incorporating a disclaimer that makes it clear to the consumer that the “jury is still out” on the ultimate conclusion suggested by the claim, but at the same time gives the consumer solid information to make critical purchase decisions.⁶

Fast forward several years to the emerging body of evidence developing around the powerful anti-carcinogenic effects of selenium.

Selenomethionine - an amino acid containing selenium.

This body of evidence shows significant correlation between selenium intake and the reduction in risk for certain cancers including cancers of the prostate, lung, respiratory tract, colon, and digestive tract.  Is the evidence conclusive?  No.  But is it powerful and supported by valid studies using recognized methods and conducted by reputable scientists?  Yes.

In reliance upon the body of evidence developed, Pearson and Shaw petitioned the FDA for approval of five qualified claims for selenium.⁷  Four out of the five claims were rejected outright.  A fifth claim, for prevention of prostate cancer, was saddled with disclaimers that were so onerous it was almost not worth making since the disclaimer was so long you could barely even fit it on the box or bottle with the supplement.

Some perspective is valuable here: FDA reviewed 233 studies in the course of its review of the challenged claims.  Pearson and Shaw submitted 77 studies as supportive of their claims.  According to the Selenium Challenge complaint, almost all the evidence submitted was ignored by FDA.  To their credit, Pearson and Shaw acknowledge that the evidence is not conclusive, but they do seem to have the weight of the credible scientific evidence on their side, much of which is detailed in the Selenium Challenge complaint complete with citations to the literature.

Pearson and Shaw also petitioned the FDA for approval of qualified claims for the antioxidant effects of Vitamins C and E.⁸  The claims consisted of ten Vitamin C qualified health claims and 7 Vitamin E qualified health claims involving the relationship between Vitamins C and E and the reduction in the risk for cancer. In support Pearson and Shaw submitted over 200 scientific publications demonstrating a nutrient-disease relationship between vitamins C and E and site-specific cancers.

Pearson and Shaw had hope that at least some of their claims might be approved.   However, in the interim, the FDA issued its guidance document, “Evidence-Based Review System for the Scientific Evaluation of Health Claims.” In this guidance document, according to the C and E Challenge, the FDA mucked up the analysis required for qualified claims by conflating it with the higher standard set for FDA Approved Claims. Once again, FDA rejected most of the proposed qualified claims, and for the ones that it accepted it rewrote them and included so much negatively laden verbiage as to make the claims unusable.

Both these challenges seek to reorient FDA thinking (to put it mildly) as it pertains to the qualified claims review system.  Emord clearly hopes that the D.C. Circuit will take FDA to task for its failure to comply with past decisions requiring it to lift excessive burdens on the free speech rights of supplement marketers so that consumers can be fully informed about developing science behind powerful dietary therapies available to treat and prevent disease.  We will see in Part II of this post how the new cGMP system also places burdens on the commercial speech rights of supplement makers, so stay tuned…

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1. Alliance for Natural Health US, Durk Pearson, Sandy Shaw, and the Coalition to End FDA and FTC Censorship v. Kathleen Sebelius, US Dept. of Health and Human Srvcs., Margaret M. Hamburg, M.D., FDA and USA, 1:09-cv-01470-ESH, Aug. 4, 2009, Huvelle, J.
2. Alliance for Natural Health US, Durk Pearson, Sandy Shaw, and the Coalition to End FDA and FTC Censorship v. Kathleen Sebelius, US Dept. of Health and Human Srvcs., Margaret M. Hamburg, M.D., FDA and USA, 1:09-cv-01546-RJL, Aug. 14, 2009, Leon, J.
3. Alliance for Natural Health US, Durk Pearson, Sandy Shaw, and the Coalition to End FDA and FTC Censorship v. Kathleen Sebelius, US Dept. of Health and Human Srvcs., Margaret M. Hamburg, M.D., FDA and USA, 1:09-cv-01523-CKK, Aug. 12, 2009, Kollar-Kotelly, J.
4. See, e.g., Pearson v. Shalala, 98-5043 (D.C. Cir. Jan. 15, 1999) and Whitaker v. Thompson, 03-5020 (D.C. Cir. Jan. 9, 2004)
5. See, Central Hudson Gas & Elec. v. Public Svc. Comm’n, 447 U.S. 557 (1980)
6. See Guidance for Industry: FDA’s Implementation of “Qualified Health Claims”: Questions and Answers; Final Guidance  (29 August 2009)
7. Selenium and a Reduced Risk of Site-specific Cancers, FDA-2008-Q-0323
8. Petition for Qualified Health Claims: Antioxidant Vitamins C and E and Reduction in the Risk of Site-Specific Cancers, FDA-2008-Q-0299

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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