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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In the trade, it is called public service journalism, but this may qualify more as a disservice.  In the Sept. 21 issue with Tim Tebow on the cover (again?), ESPN Magazine devotes two well-illustrated and detailed pages on performance-enhancing drugs. This is a must read for every attorney who represents an athlete who tests positive. The article probably should not be allowed in the libraries of middle and high schools.

Curious about how to get in shape before pro hockey or baseball season starts? Use Tri-Test, says ESPN. Want to come off a steroid cycle? Do like Manny Ramirez and take HCG. The article explains how each drug works, its legal status with the World Anti-Doping Agency, and why athletes risk taking the product.

The article gives popular other names for a drug; our favorite is Apache, Dance Fever and Goodfella, all of which refer to Fentanyl, a synthetic opiate that ESPN writes has achieved popularity among some weightlifters.

ESPN warns, “Don’t try these at home,” to which we would add, ” or in a clubhouse, at a track meet or in a weight room.”

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We are not sure of the reason, but it seems that every three months or so, a national media outlet weighs in on an old story: tainted nutritional supplements. To be sure, the story will not go away in the sports world. Athletes who test positive for steroids often say they thought they were taking vitamins.

The dietary dangers faced by professional players is a good launching point for a substantive news story. If the pros can be victims, what about the amateurs playing high school and college sports? What are the players’ coaches doing about the dangers of contaminated supplements? Are industry forces and organized sports working together to eliminate the problem? If not, why not?

No, we get a rehash of anecdotes with the same question: Are vitamins safe? So goes the Sept. 7 article in the Wall Street Journal headlined, “What’s Really in Supplements?” with the ominous sub-headline, “Regulators and Physicians Raise Alarms About Dangerous Ingredients in Many Herbal Remedies.” The illustration is scarier; it features demons escaping an opened capsule.

Among the article’s weaknesses:

• No one at the FDA raises an alarm. One FDA official says consumers should read labels and another says that the agency is doing the best it can to find and ban bad products.
• Just a few — not the headlined many — herbal remedies are cited as causing problems. The article reaches back five years to a now-banned substance as an example. Why bring up ephedra if product integrity is an issue today?
• No event gives the article urgency. No one famous has become ill or died from taking a supplement. The most notable recalled product of recent times is Hydroxycut, which gets no mention. The article says that the  FDA will hold hearings this month without giving specifics.
• The reader service is laudable, but not prominent enough. The first mention of information sources about supplements appears in the fifth paragraph, after the anecdotal lead about a policeman who unwittingly took steroids.
• Statistical evidence of the prevalence of product contamination devolves into a he-said, she-said between HFL Sports Science and the Council for Responsible Nutrition.

After all of that, the Journal article treads on much of the same ground covered in a May 18 Sports Illustrated article that also fed on fear with the headline, “What you don’t know might kill you.” Where is the news?

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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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David Ortiz

The confusion surrounding steroid use in professional baseball has taken another strange turn. The Associated Press and New York Times report that eight of the 104 players who tested positive for steroids in 2003 fall into another category. The AP says that the eight did not test positive; the Times says that the eight took 19-norandrostenedione, which was legally sold over the counter at the time. It is now illegal and a player caught with it in his system will be suspended for 50 games.

David Ortiz has said from the time his name was publicly tied to the list that he had been taking vitamins. At a press conference on Aug. 8 before his Boston Red Sox played host New York Yankees, Ortiz said that he had bought supplements in the Dominican Republic and the United States. “I’m not here to make any excuse or anything,” according to a Times article. “I really used a lot of supplements and vitamins.” He added that companies would send him supplements, “but I never used or buy any steroids.”

Former Red Sox teammate Manny Ramirez, Yankee Alex Rodriguez and former Chicago Cub Sammy Sosa were also on the 2003 list. But for what? The details are in the hands of federal investigators, the players’ union cannot tell its members, and a federal judge has told everyone to keep their mouths shut.

Any language confusion in identifying nutritional products may seem unimportant to the public, but to folks in this industry there is a huge difference between a vitamin and a steroid. Or a supplement and a steroid.

When companies do not make the distinction to the satisfaction of the FDA, they hear about it. In October 2004, the agency wrote a warning letter to All American Pharmaceuticals and Natural Food Corporation regarding the labeling of the prohormone as a dietary ingredient. “FDA is not aware of any information demonstrating that androstenedione, 19-norandrostenedione, and 5-androstene-3b 17b-diol were lawfully marketed as dietary ingredients in the United States before October 15, 1994,” the letter said in part.

Apparently, 19-norandrostenedione is pretty strong stuff: “One of the most frequently misused steroid precursors (prohormones) is 19-norandrostenedione (4-estrene-3,17-dione, NOR), which is, after oral administration, readily metabolised to nortestosterone, also known as nandrolone (durabolin),” begins the abstract to a study published in 2008 on the prohormone. Its effect on the careers of All-Star players and Major League Baseball is being felt today.

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Hamburg

The FDA has put supplement companies on notice that violators can expect earlier detection and prosecution. Remarks by commissioner Margaret Hamburg on Aug. 6 strongly suggest that the agency has shifted to a policy of less talk and more action. In a speech to the Food and Drug Law Institute, Hamburg said the FDA will be more vigilant, strategic, quick and visible.

To that end, Hamburg said the FDA has instituted six policy changes:

• Fewer, if any warnings. “If we find that we must move quickly to address significant health concerns or egregious violations, we will consider immediate action – even before we have issued a formal warning letter,” Hamburg said.
• Greater emphasis on swift enforcement. “When the public health is at risk, the FDA will reach out to our partners to take rapid action while we alert the public and prepare longer-term responses,” she said.
• Fewer warning letters. The letters are now limited to significant legal issues. “Most enforcement letters will be able to move forward through a more streamlined process.,” Hamburg said.
• Shorter post-inspection deadlines. “When the FDA finds that a firm is significantly out of compliance, we expect a prompt response,” she said. “The firm will generally have no more than fifteen working days in which to respond before the FDA moves ahead with a warning letter or enforcement action.”
• More follow-up on enforcement actions. “After a warning letter is issued or a major product recall occurs, we will make it a priority to follow up promptly with appropriate action, such as an inspection or investigation to assess whether or not a company has made required changes in its practices,” Hamburg said.
• Public notice of completed corrections. “We will provide to the firm a ‘close-out’ letter, indicating that the issues in the warning letter have been successfully addressed.”

In sum, a supplement maker can expect a knock on the door before getting a letter in the mail. If the FDA perceives a significant risk to public health, it will ask enforcement agencies to take immediate steps. In some circumstances, there will be no warning and no negotiation before a plant is shut down or a product is recalled.

Why is the change in policy needed? Hamburg, who has been on the job just 90 days,  pointed to slow action on serious violations regarding product quality; adulteration and misbranding; false, misleading, or otherwise unlawful labeling; and misleading advertising. Agencies took to long to respond because of procedures and policies, she said.

The industry response must be to get better or get out. Get better at controlling ingredient quality; get better at manufacturing; get better at documentation; get better at advertising and marketing; get better at legal representation. Otherwise, get out of the business.

While the actions may seem harsh, they increase the public’s confidence in the dietary supplement industry, Hamburg said.  “The solution is a commitment to compliance backed by a strong compliance program. Now is a good time to reassess whether you have such an effort in place.”

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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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