Archive for the ‘Sports Nutrition’ Category

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

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 »

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.

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

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.

Last month it was reported that about one-third of FDA’s 90 dietary supplement Good Manufacturing Practices (GMP) inspections in fiscal 2010 revealed severe compliance problems.  The most common GMP problem was reportedly “inadequate identity testing.”  Undoubtedly, relying on certificates of analysis from the raw materials supplier without further testing, or failing to conduct identity testing of a finished product, can result in the creation of a product that contains something it shouldn’t – such as synthetic chemicals or even pharmaceutical drugs.  However, a recent article in The Tan Sheet (10/11/10, page 4) refers to all of these products as “spiked” – even in situations where the presence of the undeclared ingredient is inadvertent.  The indiscriminate use of the term “spiked” by The Tan Sheet only serves to confuse the situation.  The most common use of the term refers to intentionally putting alcohol or drugs into someone else’s drink.  “Spiking” a product connotes intentionally slipping a powerful but undeclared ingredient into it to cause a desired or enhanced effect.  And that’s simply not always the case; particularly when you consider that some of the undeclared substances that have been reportedly discovered in some dietary supplement products are either contrary to, or would not enhance, the desired effect of the product and have been found in an amount that is unlikely to have any physiological effect.

 Certainly, there have been situations in the supplement industry wherein a domestic manufacturer, or even a raw materials supplier, has intentionally added an undeclared drug or chemical to the product to enhance its effect.  This is true “spiking” and it is our recommendation that the term be applied only to this scenario.  This is clearly a criminal act.  Manufacturers who “spike” products do so in violation of the FD&C, and if the undeclared ingredient is a controlled substance, the DEA also has jurisdiction. 

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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.