Author Archive

There have been several occasions when an athlete has tested positive for a substance banned by their governing body.  Sometimes it is because of false positive, a few times it is because of a less than scrupulous manufacturer spiking their product.  Most of the time though it is because the athlete does not take the time to find out whether or not an ingredient is prohibited.  Such was the case of Maryland-based track athelete Phillipe H. DeRosier, Jr.

DeRosier tested positive for a stimulant called DMAA that is contained in a popular nutritional supplement, Jack3d made by USPlabs.  DeRosier was banned from competition and sued USP Labs.  A federal judge dismissed his $1.8 million lawsuit.  The judge ruled that testimony supporting his claim was ”wholly speculative and conclusory.”

One of the main reasons for the dismissal was that the ingredient is listed on the product label.  The product is being sold on the open market.  And while some ingredients are openly being sold, they may be banned by sanctioning bodies.  That is why it is important for any athlete consuming dietary supplement products to read the label and check to be sure that there is nothing in there that would be prohibited by their sanctioning body.

It is also good practice for companies who have ingredients in their product that may be banned by sanctioning bodies or that can result in false positives to put warnings on their labels that though the ingredient is appropriate it may be banned by not only athletic bodies, but by law enforcement agencies and other employers who regularly test their employees.  This can be a further risk management endeavor to eliminate the risk of costly defending oneself from a suit such as this.

When clients ask me about insurance, my response is that they should not look at insurance as a separate issue but rather as part of an overall risk management program for their company.  A risk management program encompasses several things.  The idea is to minimize your company’s exposure to lawsuits, regulatory investigations and other distractions that can not only cost you time and money but, if serious enough, sink your company and everything you have worked for.

In addition to insurance, one needs to look at several factors to manage risk.  Included among those factors:

• Do your independent reps have auto insurance on their vehicles?
• Have your claims on your labels and advertising gone through legal review?
• Do you have a written AER policy and are you following it?
• Are you managing and adhering to good manufacturing practices and are you checking to make sure your manufacturers and raw material suppliers or doing so as well?
• Have you trained your customer service representatives on how to properly respond to inquiries and do you have a written policy on how to handle emergency types of calls?
• Do you know what to do when FDA shows up for an inspection at your offices?

All of these are part of your risk management program.  And questions like these are asked by insurance underwriters … how you answer them may affect your rates.
Read the rest of this entry »

Just before the start of July 4th holiday the U.S. Food and Drug Administration released a Draft Guidance for Industry, which is entitled, Dietary Supplements: New Dietary Ingredient Notifications and Related Issues. While it does not carry the authority or the enforceability of a law or regulation, it does when finalized, represent the Food and Drug Administration’s (FDA’s) current thinking on this topic of NDIs.

The FDA has asked for comments to be provided within the 90 day period that follows its issuance. We will be contacting our clients to discuss this matter with them, to assess how this Guidance will affect the products they manufacture and sell and to get their input to be included as part of a response which we will be filing. We will also assist them to prepare their own comments, which we encourage every manufacturer, distributor, retailer or supplier of dietary ingredients to submit.

There are some highlights to what FDA has put forth that you should be aware of:
Read the rest of this entry »

Senator Patrick Leahy has re-introduced a bill that aims to impose strict penalties on people who knowingly distribute contaminated food.  The bill would allow prison terms of up to 10 years.  While most people will look at this bill as addressing the salmonella issue commonly associated with eggs, peanuts, and other foods often seen in the headlines, one must not forget that dietary supplements are categorized as food.  It would be a simple step to use this bill, if it passes, to prosecute those distributors of supplements who knowingly distribute products that are contaminated with illegal steroids or prescription drugs.  We will keep you advised of the bill’s progress.

FDA recently published guidelines for recommending the filing of criminal misdemeanor charges against owners and executives of supplement companies.  These are included in the agency’s regulatory procedure manual to give procedures as to when they should recommend to Federal prosecutors the filing of indictments of individuals when there is a violation of the Food, Drug & Cosmetic Act.

The agency will look at the person’s position and authority, whether the violation was obvious, the severity of the violation, whether there is a likelihood of harm to the public, as well as if there was a pattern of illegal behavior and whether or not warnings were ignored. One does not have to meet all of these criteria, but these are the factors FDA will look at to determine whether or not charges should be filed.

Read the rest of this entry »

While it is more common to read about fines, consent decrees, and recalls, if you make unlawful claims and engage in other illegal activity you may be prosecuted criminally. Recently, two marketers of dietary supplements received prison sentences in addition to the 11.9 million dollar judgment that was levied against them, for making illegal claims that the products they sold could prevent, treat or cure various diseases. Tony Pham, who operated Techmedica Health Inc, and Charles Thao of Nutrapha Research LLC pleaded guilty to conspiring to violate the Food, Drug and Cosmetic Act and to commit wire fraud, mail fraud, and money laundering. Additionally, both men are accused of using computer technology to hide their illegal websites by using “mirror image technology” to cause alternative websites with “sanitized” claims to be displayed whenever they were visited by someone with an FDA ISP address. While clever, the only people they’ll be able to brag to now will be their fellow inmates. Pham will serve three years in prison without parole and Thao was sentenced to eight years and one month without parole.

For additional information on this story, click the link below: http://www.fda.gov/ICECI/CriminalInvestigations/ucm234904.htm

Congressman Fred Upton, R-Michigan

Republicans are traditionally known for a “less government” attitude. Historically, when they are in power there has generally been less emphasis on enforcing existing regulations or implementing new regulations upon industry. Now that Republicans control the House of Representatives, what direction will regulators take? While the past would seem to indicate that a diminished regulatory atmosphere would be expected, some believe the exact opposite will happen. The theory is that if Congress is preoccupied with gridlock on other major issues, regulators will start to take matters into their own hands. As the dietary supplement industry has been long criticized as insufficiently regulated, it may be the sort of “low hanging fruit” ripe for attention.

On the other hand, now that the Republicans are in power, certain committee chairmanships will now be in Republican hands. The most important committee for the Dietary Supplement industry is the Energy & Commerce Committee. The committee has been chaired by Rep. Henry Waxman, a Democrat who has never been predisposed to work with our industry. The new chairman, Michigan Republican Fred Upton, may be more moderate in the regulatory approach taken with respect to our industry.

So, there are arguments that can be made for both a greater and lesser regulatory emphasis in the coming year. But regardless of the direction taken by members of Congress, the fact remains that the relevant agencies (e.g., FDA) are still staffed with Obama appointees who have already shown that they are more aggressive in enforcing the existing regulations. And that is not going to change anytime soon.

In addition to their work in helping their many dietary supplement industry clients nationwide, members of CMG are also involved in a variety of outside activities including many philanthropic ones.  This past summer, Rick Collins organized his international Leap For Life skydiving campaign, raising many thousands of dollars to support LiveStrong’s fight against cancer.  He now has three jumps from 13,500 feet under his belt!  Alan Feldstein, who also runs the Infinite Kayak safari company in Tanzania, Africa, supports the education of the Maasai tribesmen in Africa.  This past week, in his capacity as the Chairman of the Southern California Chapter of the Explorer’s Club, Alan hosted actress and conservationist Stefanie Powers for a large gathering in his Los Angeles home.  Stefanie is the founder of the William Holden Wildlife Foundation which supports conservation efforts in Kenya, and is also promoting her book “One from the Hart.”  As we approach this Holiday Season, let’s not only be grateful for everything we have in our lives, but also help support those who are working hard to make a difference in our world.  Please help support your favorite charities.

A FDA Transparency Task Force proposed 21 suggestions to help consumers, industry and others learn how FDA operates and behaves in the manner it does.  One of those suggestions was to provide the public with online information about adverse event reports.  Though they recommend that such online information should come with a clear disclaimer about the limits of the information, such a database, even if it was updated regularly, could create huge headaches for industry.  In slow economic times everyone is looking for ways to work and make money – including plaintiff class action and personal injury lawyers.  To allow them to sift through the database may create substantial risk of frivolous but extortive lawsuits.  However, this does not mean one should not comply with the rules regarding AERs and, most importantly, have written SOPs on how to maintain a thorough and accurate database of AERs.

Claims about probiotics helping the digestive system and protecting immunity have been around for decades.  However, 2 recent regulatory actions, one involving the FTC and Nestle and the other a warning letter sent from a California District Attorney, show that probiotic claims beyond those traditionally recognized might bring about greater scrutiny.  If you are marketing a probiotic product be careful about extrapolating those general claims to ones such as preventing illness and other health claims.