Author Archive

For the tenth consecutive year, the lawyers of CMG traveled to Columbus, Ohio to attend the Arnold Fitness Expo, arguably the biggest annual trade show for the Sports Nutrition industry. The Expo gives us an opportunity to meet with clients, many of whom are located across the country, as well as other industry folks, and to discuss product trends, new ingredients, and matters of interest to the industry. We also show our support for the event and the sport of bodybuilding as a whole by sponsoring the Arnold Amateur Bodybuilding, Fitness, Figure, Bikini and Arm Wrestling competitions.

This year, the buzz centered around the GMPs, FDA inspections, and the controversial methylhexaneamine or 1,3-dimethylamylamine, a popular ingredient featured in a growing number of “fat loss” products marketed in the sports nutrition category. The discussion primarily focused on the legality of the substance as a dietary ingredient and recognition by many that the issue has likely garnered the attention of FDA.

Another hot topic was the NDI guidance document expected to be issued by FDA in June of this year. Whether or not the guidance document will be released on time, one thing is certain; when it is finally issued, it will have a profound effect on the marketing of New Dietary Ingredients in the sports nutrition market. Following our return, we are busier than ever, but we will continue to strive to update our blog as these matters unfold.

Mike DiMaggio, left, at the NYCLA MMA Forum

The legalization of Mixed Martial Arts in New York continues to be a hot topic for not only fans of the sport, but the legal and regulatory communities as well.  These different communities all came together recently at a public forum presented by the New York County Lawyers’ Association (NYCLA) – where dozens of MMA enthusiasts, attorneys and others in the sports promotion industry gathered to learn more about the legal and regulatory issues surrounding legalizing MMA in New York – as well as the potential economic impact if it were legalized.

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Alcoholic energy drinks have recently come under serious scrutiny after being linked to several incidents of consumer illness and criminal violations. The widely publicized episodes have resulted in multiple statewide bans, but there are some who would like to see things taken a step further; New York Legislator Lynne Nowick wants to keep any and all energy drinks out of the hands of children and teens.

 In December, the office of the Suffolk County legislator released a statement announcing her intention to ban the sale of energy drinks with more than 80mg of caffeine (the equivalent of a strong cup of coffee) to anyone under the age of nineteen. Nowick has said that she believes that energy drinks are potentially dangerous to children and young adults and that this legislation would help to protect them.  She cited FDA’s lack of regulation and possible negative interactions between ingredients contained in the drinks and prescribed medications as the leading reasons for the proposed ban.  If passed, the ban would be the first of its kind in the US, though in the past state legislatures in Maine and Kentucky have attempted to pass similar prohibitions to no avail. Read the rest of this entry »

On Tuesday, January 4^th 2011 President Obama signed the FDA Food Safety Modernization Act into law. This is the first major food oversight reform for FDA since 1938. The law will give FDA mandatory recall authority and will allow for greater access to the records of companies whose products are deemed at high risk for causing potential adverse events. Additionally, FDA plans to step up the frequency of facility inspections, bringing the minimum up to once every 5-7 years instead of the previously mandated 8-10. Imported products will also face greater scrutiny, as the new law will require safety certification and supplier verification for all foodstuffs brought into the US. With some limited exceptions, the new legislation covers all food products, including dietary supplements. Supplement manufacturers and importers should consult with qualified legal counsel to fully understand how this will affect their business. 

The legislation does not, however, include any significant increase in FDA’s budget, leaving many wondering how the agency will fund the new procedures it hopes to put into effect. Several members of the now Republican controlled House of Representatives have stated that they do not believe the overhaul is necessary and that they will not support the additional funding needed to make many of the new enforcement measures a reality. Nevertheless, FDA Commissioner Margaret Hamburg remains optimistic; she has publicly stated that she believes FDA will be able to work with Congress to find the funding needed to realize the new law’s food safety objectives.

In late November it was announced that the head of FDA’s Office of Criminal Investigations (OCI), Terry Vermillion, would be resigning in December after leading the unit for almost two decades. Vermillion, who spent twenty years in the Secret Service prior to joining FDA, has faced criticism in the last several years from House and Senate Republicans who questioned OCI’s prioritizing of drug-abuse cases, generally agreed to be the jurisdiction of DEA, over broader violations by large companies. Read the rest of this entry »

On December 21st, The FDA Food Safety Modernization Act passed both houses of Congress. The legislation was presented to the president on Decemeber 29th and has yet to be signed into law.

The law will give FDA mandatory recall powers and increased access to records, affording greater authority over about eighty percent of the food supply. Additionally, manufacturers, both domestic and international, will be required to employ food safety regulations.

Click the link to read the full the full text of the bill: FDA Food Safety Modernization Act

Sen. Richard Durbin

As you may have heard, S. 510 contains provisions that could have profound affect on the dietary supplement industry. The Senate Bill is sponsored by Sen. Richard Durbin and co-sponsored by Senators Orrin Hatch and Thomas Harkin, among others. The Food Safety Bill, the companion version of S.510 proposed in the House of Representatives, was met with adamant opposition by the various trade associations that represent the dietary supplement, herbal and natural products industries. However, key modifications to the Senate Bill, due in part to industry lobbying, may result in a more palatable piece of legislation. As of this writing, the amended version of S.510 is out of committee and a vote in the Senate is scheduled for Monday, November 29^th. For updates on the status of this and other legislation that affects our industry, please check back with us often.

For an overview of the legislation and to keep abreast of any additional amendments, we suggest: http://www.govtrack.us/congress/bill.xpd?bill=s111-510

The full text of the legislation can be found here: S. 510 FDA Food Safety Modernization Act

The Center for Drug Evaluation and Research (CDER) has indicated that among its’ enforcement priorities, CDER will take special aim at the manufacturers of dietary supplements found to be spiked with pharmaceuticals. Echoing the sentiments of FDA Principal Deputy Commissioner Josh Sharfstein, CDER has indicated that the areas identified within the industry as having the highest number of offenses are “weight loss, sexual enhancement, and bodybuilding,” with over 200 tainted products discovered by FDA. CDER’s newly formed Division of New Drugs and Labeling Compliance urges the supplement industry to stay vigilant and hold itself accountable for the products they sell by remaining informed about the materials they buy, the suppliers they are buying from, and what is added to the products.

 CDER was recently involved in the voluntary recalls initiated by several firms that marketed “aromatase inhibitors.” The Center suggested that these ingredients posed a serious “health hazard” to consumers, an allegation refuted by the companies that marketed those products, citing a lack of adverse event reports that would support such a risk. CDER is also often consulted by Customs Enforcement and FDA Compliance Officers when evaluating dietary ingredient imports. The message to supplement firms is that dietary supplements are a priority for FDA and enforcement may come from a variety of branches.

Manufacturers, beware. FDA has announced plans to utilize the Park Doctrine to bring misdemeanor charges against CEOs and other corporate officers for violations of the Food, Drug and Cosmetic Act. The agency says that it will begin to put increased pressure on federal prosecutors to take misdemeanor cases, hoping that the fear of conviction will be an effective deterrent against criminal behavior.

The Park Doctrine allows the government to hold corporate officers, including but in no way limited to CEOs, accountable for misdemeanor violations regardless of whether or not they had prior knowledge of any wrongdoing. The central principle of the Doctrine is that even if they did not know a violation was being committed, a corporate official, just by virtue of their post, has the power to prevent it.

The Park Doctrine may prove to be a powerful tool for FDA, whose officials have indicated that government sanctions have not been effective in preventing criminal behavior, specifically citing the prevalence of off-label marketing within the pharmaceutical industry. Under the Park Doctrine, prosecutors will have no obligation to prove that a defendant had intent to commit a violation, prior knowledge of a violation, or engaged in negligent conduct. The fact that the defendant is a corporate officer will be enough for the prosecution to gain a conviction.

FDA will most likely begin by targeting off-label promotion within the pharmaceutical industry in its initial cases; however the use of the Park Doctrine sets a new precedent in the manner in which FDA will be pursuing violations. It would not be surprising to see supplement companies pursued in the coming months and years. This move from the FDA should be taken as a wake-up call for the pharma and supplement industries to take decisive action while they’re ahead. Companies that make the decision to be proactive and take a close look at their products and procedures may ultimately escape a potentially costly and embarrassing legal situation further down the road.

Q & A with David Schwartz, Ph.D. of Innovative Science Solutions, LLC

As a law firm, we often work with consultants when a client’s needs require both legal and scientific expertise. For instance, if we are preparing a New Dietary Ingredient Notification for a client or a claim substantiation package or an evaluation of the safety and regulatory compliance of a dietary ingredient, the scientific consulting group Innovative Science Solutions, LLC (ISS) is the team of chemists, biologists, physiologists, and toxicologists that we often turn to for their scientific expertise. As an example of the kind of insight that we have come to rely on from ISS, we were interested in their take on the July 29, 2010, British Medical Journal article linking calcium supplements to an increased risk of myocardial infarction.[1]  [BMJ - Calcium Supplements and MI] We spoke with David H. Schwartz, Ph.D., head of the Liability Support Practice at ISS about the findings from this study and the implications for individuals taking calcium supplements. (Editorial Comments)

 Q:  What type of study was this?

 A:  Actually, it was not original research, but rather an analysis of 11 separate, placebo-controlled clinical trials. This type of analysis across already completed trials is called a “meta analysis.”

 Q:  What were the investigators looking for?

 A:  The primary endpoints examined were myocardial infarction, first stroke, and first event for the composite of myocardial infarction, stroke, or sudden death.

 Q:  And how did they study this?

 A:  Each individual clinical trial publishes a single number to represent whether each of these events was more likely or less likely to occur with calcium supplementation.  These investigators did a statistical analysis on all 11 placebo-controlled trials and determined whether each of the events was more or less likely to occur with calcium supplements.

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