Archive for the ‘Marketing and Advertising’ Category

Collins Recognized for His Leadership as Attorney, Author and Fitness Authority, and for his Philanthropic Efforts in Creating Worldwide Skydiving Fundraiser

Rick Collins, a partner at Collins, McDonald & Gann, P.C. (www.cmgesq.com) and a leader in the health/fitness community, has been named by the Long Island Business News as one of Long Island’s Fifty Around 50 – Class of 2011. He was honored on Thursday, October 20 at an awards ceremony celebrating the Class of 2011 inductees, which was attended by hundreds of leading business professionals throughout the region.

Collins was selected as one of this year’s “Fifty Around 50” based on his leadership in business, mentoring, support for Long Island’s not-for-profit organizations and commitment to the community. The award was designed to recognize “the intelligent, hard-working and dynamic men and women dedicated to Long Island’s strong, successful companies and organizations.” Business leaders named to the list were chosen both for their outstanding professional achievements and leadership, as well as for their philanthropic efforts and community involvement.
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This Saturday, September 17^th, 2011, at the Las Vegas Convention Center Expo, Room S219, the attorneys of CMG will be speaking as part of the International Society of Sports Nutrition’s (ISSN) Europa University.

From 2:00pm-3:00pm PST – Rick Collins, Esq., FISSN, joined by Alan Feldstein, Esq. and Michael DiMaggio, Esq. will be conducting a presentation entitled: FDA Draft Guidance on New Dietary Ingredient Notifications: Is it a “Game Changer” for the Sports Nutrition Industry?

The presentation will include issues such as:

• How FDA’s most recent guidance will affect innovation in the sports nutrition industry.

• The Nuts and Bolts of NDI Notifications: requirements, process and exemptions.

• What industry and consumers should know about supplement Safety Data and studies?

Please join ISSN and the attorneys of CMG this Saturday for this important presentation.

While so many in the industry seem to be talking about NDI notifications as the biggest issue facing supplement companies, a recent poll of approximately 100 attendees at the recent United Natural Products Alliance (UNPA) seminar indicates that there’s another issue of more concern in the supplement industry today: GMP compliance. According to the survey results, reported in the August 15^th “Tan Sheet” (see thumbnail image), 60% of the attendees polled said that GMP compliance is currently the most important issue facing the industry – compared to only 31% of attendees who believe that NDI notification tops the list of current concerns.

Those polled aren’t the only ones noting the importance of GMP compliance on the industry; according to Daniel Fabricant, director of FDA’s Division of Dietary Supplements, “GMPS are probably the most substantial thing industry has to work on” – noting that the FDA “is seeing a pretty high rate of noncompliance.” Fabricant went on to note that “the industry should expect more GMP enforcement” – but also disconnected the two issues by saying that the agency would “likely not” enforce NDI notification through GMP inspections.

So, for now, NDI notifications and GMPs remain two separate issues – with, it appears, more in the industry possibly less concerned about NDIs than they are about GMP compliance in today’s complex supplement industry. Therefore, as GMP compliance continues to be a growing issue, ensure that your company is following all proper practices and adhering to all current and future regulatory guidelines – and, to best meet any potential expanded GMP enforcement, consider seeking professional legal counsel to help you navigate through this important time.

Bradford W. Williams

May 2^nd to 4^th 2011 – Once again, SupplySide_® East, held at the Meadowlands Exposition Center in Secaucus, New Jersey, played host to thousands of folks involved in the food, beverage, cosmetic, personal care and dietary supplement industries. In addition to the nearly 300 exhibitor booths, SupplySide_® East also featured a variety of Speakers presenting on topics of interest to members of industry. Bradford W. Williams – presently the manager for the Division of Dietary Supplement Programs, Office of Nutrition, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition (CFSAN), of the Food and Drug Administration (FDA) – focused much of his presentation on GMP Compliance and FDA’s inspection priorities as well as the major findings from the last 18 months of inspections.

According to Williams, FDA’s GMP inspection priority begins with manufacturers that blend and fabricate products, followed by companies that package and label finished products, and then entities that merely attach the product label. He indicated that FDA’s major findings included the following violations:

• Inadequate or failure to conduct identity testing
• Failure to establish specifications for components, ingredients, steps and stages of manufacturing and finished products
• Failure to conduct testing to ensure product meets specifications
• Failure to maintain adequate master manufacturing records (MMR) and Batch product records (BPR) content and recordkeeping requirements
• Failure to conduct material reviews
• Lack of adequate corrective action plans (CAP)

Williams indicated that after reviewing the 2010 FDA GMP inspections, the violation rate is estimated to be nearly 25%. Unfortunately, this is an indication that the industry is having a difficult time coming into compliance. If you have questions about the GMPs or need guidance on compliance measures, please call our office at (516) 294-0300.

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.

Last week, Citizens for Responsibility and Ethics in Washington (CREW), a legal watchdog group, released “research demonstrating that the dietary supplement industry spent millions of dollars on well-connected lobbyists and made numerous campaign contributions to successfully thwart increased regulatory oversight of supplements.” (Read CREW’s report here)

 CREW’s press release targeted Utah Republican Sen. Orrin Hatch as being “[f]ar and away the largest recipient of campaign contributions from the supplement industry in the 2010 election cycle” for taking in the apparently whopping sum of $45,780. 

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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

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 »

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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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.