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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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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This is a tale of two types of weight-loss products and how the Food and Drug Administration had different responses to similar problems with them. The separate, but not equivalent treatment raises questions about how the FDA operates.

On Aug. 24, the FDA issued a statement about an ongoing safety review of orlistat based on reports of liver injury in people taking the weight-loss drug. It is marketed as the prescription drug Xenical and the over-the-counter medication Alli.

The FDA said it had received 32 reports of serious liver injury in patients taking orlistat between 1999 and 2008.  Of those cases, 27 required hospitalization and six resulted in liver failure.

Sound familiar? It should. On May 1, the FDA issued a warning about the danger of Hydroxycut based on 23 reported liver problems over seven years, including 16 hospitalizations. One person died in February 2007 after taking that weight-loss product.

That is where the stories diverge. For orlistat, the FDA is conducting a review because, “no definite association between liver injury and orlistat has been established at this time,” according to the release. “Consumers taking Xenical should continue to take it as prescribed, and those using over-the-counter Alli should continue to use the product as directed.”

In contrast, the FDA told consumers to stop immediately using Hydroxycut even though the agency acknowledged in a health hazard evaluation board report that “The Board does not know what ingredient(s) of Hydroxycut are responsible for producing liver toxicity. In addition, there is insufficient information to determine whether there is a dose-response effect between Hydroxycut ingestion and liver disease or whether its effects are cumulative over time.”

Despite a lack of direct evidence, the board concluded “that the ingestion of the dietary supplement, Hydroxycut, presents a severe potentially life-threatening hazard to some users.” The makers of Hydroxycut immediately ordered a recall.

What might the same health board members think about orlistat? It has caused liver injuries for a longer time period and has put more people in the hospital with similar ailments — jaundice and liver failure.

Does the FDA give greater weight to the patient death? If so, it seems to us that the product would have been recalled in 2007.

Is the difference the way the products are regulated? The FDA approved Xenical in 1999 and Alli in 2007. None of the ingredients in Hydroxycut were identified in the report as needing FDA review.

If the distinctions are not clear from a review of the facts, then what are we to expect the next time a weight-loss product is associated with health problems?

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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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GUEST BLOG by David A. Mark

The Institute of Medicine is currently reviewing the Dietary Reference Intake value for vitamin D that last changed in 1997. While a final report is not expected until May 2010, some dietary supplement companies are boosting their dosages now. The increases have implications not only for consumer health but for regulatory action.

The Tolerable Upper Intake Level for vitamin D for adults today is 2,000 International Units per day. The Daily Value is 400 units. Depending on a person’s age, the Adequate Intake is between 200 and 600 units. Those numbers could go higher once the Institute issues its report.

Most people get 100 to 200 units of vitamin D daily from their food. Most multivitamins provide a daily dosage of 400 units. Some manufacturers have begun to offer products with 1,000, 2,000 and even 5,000 units per day. The last is more than double the current upper limit.

Is there a benefit – or a danger — from getting more vitamin D? A growing scientific consensus says that a combination of food, dietary supplements and the typical exposure to sunlight is not sufficient to reach blood levels for ideal health.

While the cumulative evidence supports an increase in the figure for adult intake of vitamin D to perhaps 1,000 units per day or higher, there is not an equivalent body of new evidence sustaining an argument for a safe, higher upper limit.

The identified risk of chronic, high, vitamin D consumption is elevated serum calcium, resulting in inappropriate tissue calcification. The current Daily Recommended Intake text identifies 3,800 units per day as leading to abnormally high serum calcium. The text also says that 2,400 units per day produces an elevated serum average, but still within the normal range. This was a small, short study without evaluation of clinical consequences. Ongoing, massive, multi-year vitamin D clinical trials may detect subtle negative outcomes. Researchers will keep an eye out for harm to kidneys and arteries.

It is reasonable to assume that the Food and Drug Administration is also watching the situation. It would not surprise me if the agency issued warning letters to companies selling vitamin D products containing 2.5 times the current upper level, telling those businesses that their products are potentially unsafe.

FDA action is not the only risk. Recently, the FDA amended the qualified health claim for selenium. Shortly thereafter, the consumer advocacy group Center for Science in the Public Interest filed a complaint with the FDA against Bayer Healthcare, stating that the existing (now superseded) label claim for One A Day Men’s Health Formula overstated the putative prostate cancer health benefit. The Center also said that recent research suggested that selenium supplementation might increase risks for hypertension and diabetes.

The center and other non-government organizations might take the same action against high-dose vitamin D products, potentially creating negative publicity, especially if new research links them to negative health effects. The supplement industry would be wise to prepare for such developments.

David A. Mark, Ph.D., is president of dmark consulting LLC, a science consulting company serving the dietary supplement and functional food industry. Contact him at david@dmarknutrition.com or 978-897-0890.

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James’ suggestions are excellent ones for supplement companies to consider at any time, not just when scrutiny is heightened.  Here are James’ suggestions:

We strongly recommend the following based upon the reading of this article and the likelihood of more consumer lawsuits, including class actions based upon false or deceptive advertising, recent developments relating to product recalls, and the ever-increasing regulatory and quasi-regulatory scrutiny of web site claims:

1. You should review, or you should have someone review, your insurance policy or policies to make sure that you are covered with respect to losses or claims that are most likely to be asserted by others or by you (for coverage by your own insurer) that arise from some alleged injury or damage from (i) the ingestion by a consumer of your dietary supplement or a supplement that you handle in some way or (ii) a product recall. This review should definitely include (1) preparation of a list of possible claims and circumstances and (2) a follow-up call or meeting with your insurance agent and a writing from an authorized representative of your insurance carrier that the coverage you desire is, in fact, provided by your policy.
2. You should again consider getting bids for contracts for the carrying out of carefully designed scientific studies to confirm or develop your major advertising and labeling claims.
3. You should make sure that the claims being made for your product, if based upon one or more scientific studies, are consistent with that scientific study or those studies.

Good advice.  I thought it was worth passing along.

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Here is the Cliff’s Notes version:

• Implement cGMPs with custom SOPs and testing
• Negotiate solid contracts with protections
• Consider recall insurance

And remember, NutriCompliance is here to help.  Many thanks to CANI for the great editorial opportunity.

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