Wednesday, February 24, 2010

Anti-Supplement “Perfect” Storm Building in Washington

By James J. Gormley

As if Senate Bill 3002 (S. 3002) were not more than enough to deal with, according to The Hill Rep. John Dingell (D-Mich.) is criticizing the Senate for not moving on Senate Bill 510 (S. 510).

Unfortunately, The Pew Charitable Trust has been assisting with a coordinated lobbying effort to press Senate leaders to bring the bill to the floor. Sandra Eskin, director of Pew’s food safety campaign, told The Hill that she is “cautiously optimistic” that a vote can occur in the first half of March, before the Senate’s next recess week starts on March 29.

Regan LaChapelle, a spokeswoman for Sen. Harry Reid (D-Nev.), told The Hill that the majority leader hopes to bring the bill to the floor either during the current work period or the next, which runs from April 12 to May 28. “It’s on our list of legislative priorities,” she said. “It could be in March or the next work period. Obviously we have many issues to address.”

House Republicans were split on H.R. 2749, with 54 supporting it and 122 opposed. GOP members who backed it include Reps. Michele Bachmann (Minn.), Joe Barton (Texas), Dave Camp (Mich.) and Greg Walden (Ore.).

After the House bill passed, Rep. Frank Lucas (R-Okla.) told The Washington Post: “The federal government will tell our farmers and ranchers how to do something they’ve been doing since the dawn of mankind. It goes too far in the direction of trying to produce food from a bureaucrat’s chair in Washington, D.C.”
Twenty House Democrats opposed the bill.

Now moreso than in recent memory, it is critical that we all stay tuned to these issues, keeping an eye out for our continuing posts and opportunities for action on S. 3002 and S. 510 — and whatever else floats down the Potomac that threatens DSHEA, our supplements and our health-food stores.

Monday, February 22, 2010

NPA Alerts Health-Food Stores to Dangers of S. 3002
According to the Natural Products Association (NPA) in an e-mail alert issued today, here is how S. 3002 would affect health-food stores:
All dietary supplements, whether vitamins, minerals, herbal products and others that were previously allowed under DSHEA, could be removed from the market under S. 3002. This legislation would mandate that every dietary supplement would have to go through a brand new process of government review (yet to be defined) in order to remain on store shelves.

For the first time in the history of food or drug law, retail establishments would need to register with the FDA. Failing to register could result in severe monetary penalties, up to two times your gross profit. Not complying with even minimal technical requirements, such as minor errors in registration, recordkeeping or reporting could be considered a criminal offense.

Retailers would also be required to obtain “adequate written evidence” from suppliers that each dietary supplement product meets all regulatory requirements. Again, failure to do so could result in severe monetary penalties.

Act now!

Wednesday, February 17, 2010

Upgrade Your Social Media Efforts

By IMG Brandwire

Social media is no longer kids stuff. With over 325,000,000 members on Facebook (50% of whom are over 35 years old) and 44 million Twitter users, most businesses are scrambling to craft effective social media strategies. Although it’s tempting to just throw something out there, keeping a few tips in mind can multiply your results and create synergy between various activities.

Make it viral. In every social media message, incentivize your followers to forward or publicize your messages to others, who, in turn, can do the same. Top incentives include photos, videos, and engaging links. Also, be certain to include an app on all messaging that allows viewers to share your info on their own profiles with a single click.

Integrate it. Build on existing public relations and marketing campaigns. Your social media arm is designed to reach out and grab your followers’ attention, but it’s not intended to provide detailed information. Include a link in every post or tweet to your website or blog so viewers can peruse your offering in greater detail. And make sure that, once they get to your blog or website, there’s something novel and interactive there to keep them involved with your brand.
Enrich the content. The best way to show your followers you appreciate them is to have something to say before you say it. As with press releases, the consuming public is weary of posts and tweets that don’t offer anything interesting, unique or relevant. Before each communication, ask yourself “What tidbit am I providing my visitors that they will find worthwhile and want to pass along?” If there isn’t one, it’s time for a rewrite. In short, think before you tweet.

Saturday, February 13, 2010

The DEA Should Take Over All Sports Doping Enforcement

By James J. Gormley

In February 2010 in New Orleans, three men were charged by the U.S. Drug Enforcement Administration (DEA) with drug-trafficking Ecstasy, or MDMA (3-4-Methylenedioxymethamphetamine), a synthetic chemical that can be derived from an essential oil of the sassafras tree.

If convicted, the defendants face a possible maximum sentence of 20 years in prison, a $1 million fine and at least three years of supervised release for each count.

MDMA is also one of the easiest illegal drugs to obtain. Its effects are similar to those of amphetamines and hallucinogens. First developed as an appetite suppressant in 1912, MDMA was used as a psychotherapeutic tool and also started to become available on the street is the late 1970s and early 1980s. It wasn’t until 1985 that Ecstasy was made illegal. It is classified as a “Schedule 1” controlled substance along with other narcotics like heroin, cocaine and LSD.

One reason Ecstasy can be especially dangerous is the lack of content control. Ingredients are hard to get and manufacturers of the drug often use substitutes, mixing other harmful additives with the already dangerous mix. This practice is so common that “drug test kits” are often sold with the drug so users can test for purity.

Because of the uncertainties about the drug sources, pharmacological agents, chemicals used to manufacture them, and possible contaminants, it is difficult to measure the toxicity, consequences and symptoms that might be expected.

Herbal Ecstasy is another form of MDMA that is composed of ephedrine or pseudoephedrine and caffeine from the kola nut. Also sold in tablet form, Herbal Ecstasy can cause permanent brain damage and death. Though not currently classified as a controlled substance, Herbal Ecstasy shares many of the same qualities and effects as MDMA. Also known as Cloud 9, Herbal Bliss, Ritual Spirit, Herbal X, GWM, Rave Energy, Ultimate Xphoria and X.

Anabolic Steroids
Anabolic steroids are synthetically produced versions of the naturally occurring male hormone, testosterone. Both males and females have testosterone produced in their bodies: males in the testes, and females in the ovaries and other tissues. The full name for this class of drugs is androgenic (promoting masculine characteristics) anabolic (tissue building) steroids (the class of drugs).

Some of the common street names for anabolic steroids include: arnolds, gym candy, pumpers, 'roids, stackers, weight trainers and juice. Currently, there are more than 100 different types of anabolic steroids that have been developed, and each requires a prescription to be used legally in the U.S.

Anabolic steroids can be taken orally, injected intramuscularly, or rubbed on the skin when in the form of gels or creams. These drugs are often used in patterns called cycling, which involves taking multiple doses of steroids over a specific period of time, stopping for a period, and starting again. Users also frequently combine several different types of steroids in a process known as stacking. By doing this, users, more properly abusers, believe that the different steroids will interact to produce an effect on muscle size that is greater than the effects of using each drug individually.

Another mode of steroid use is called "pyramiding." With this method abusers slowly escalate steroid use (increasing the number of drugs used at one time and/or the dose and frequency of one or more steroids), reach a peak amount at mid-cycle and gradually taper the dose toward the end of the cycle. The escalation of steroid abuse can vary with different types of training. Bodybuilders and weight lifters tend to escalate their dose to a much higher level than do long distance runners or swimmers.

Legislation and Enforcement
On March 16th 2004, Joseph Rannazzisi, then deputy director of the DEA's Office of Diversion Control, said in testimony before the House Subcommittee on Crime, Terrorism and Homeland Security:

"The DEA has one mission: to protect the public from dangerous drugs. However, the current law regarding steroids causes regulatory delay, especially with respect to steroids that we know are hormonally, chemically or pharmacologically related to testosterone. Because DEA’s authority extends only to controlled substances, steroids that are not classified as controlled substances continue to fall outside our jurisdiction. H.R. 3866 [The Anabolic Steroid Control Act of 2004 ] will correct this problem."

Well, the Anabolic Steroid Control Act passed in October 2004.

On the bill's passage, one of its sponsors, Sen. Orrin Hatch (R-UT), remarked:

"Under this bill, clever chemists will no longer be able to dodge the law by disguising their chemicals to skirt the legal definition of a steroid. Our bill gives the Drug Enforcement Agency the power to schedule nearly any steroid precursor now or in the future--giving the law flexibility we don't have to play catch-up with every new andro look-alike that comes along."

On September 29, 2009, the DEA's Rannazzsi, now deputy assistant administrator, said this in testimony before the Subcommittee on Crime and Drugs:

"Although DEA does not have the authority to enforce DSHEA [the Dietary Supplement Health and Education Act of 1994], DEA does have statutory authority to investigate incidents involving the illegal manufacture and distribution of anabolic adrenergic steroids in the dietary supplement market. [...] DEA has the authority and responsibility to investigate companies that are marketing products as dietary supplements that are adulterated with controlled substances."

As well the DEA should; if yogurt were suddenly used as a delivery vehicle for sports steroids, would our guardians of public health call for a new law restricting access to yogurt or would increased enforcement and enforcement funding be directed to the DEA to get the job done? The latter, I would think.

If supplements are being adulterated by illegal labs, why then should supplements get a bad rap? Steroids and sports doping is all about unethical pharmacies and illegal labs.

Case in point, in January 2009, a 198-count DEA indictment was unsealed charging 12 pharmacists and pharmacy owners with participating in a conspiracy that dispensed and sold thousands of dosages of anabolic steroids, including powerful veterinary steroids approved for animal use only.

Another case in point: in October 2009 the DEA announced the completion of a 10-month undercover investigation into an illegal anabolic steroid manufacturing ring that led to three arrests. In the raid, agents seized over 500 vials and 1,850 capsules of anabolic steroid pills.

While the U.S. Food and Drug Administration (FDA) has been involved in sweeps relating to the illegal sale of unapproved or misbranded drugs, such as the recent Internet sweep in November 2009 called the "International Internet Week of Action," many observers, including this commentator, strongly believe that all investigation and enforcement of sports doping and illegal steroid distribution and use should immediately be more clearly placed under the aegis of the DEA, as sports doping is not a problem of food products (such as supplements) but a problem of drugs---a problem of dope, pure and simple.

Sunday, February 7, 2010

The Dietary Supplement Excuse

[With the DSSA bill, S. 3002, now up for vigorous debate, it's worth taking a look back to this article of mine from 2007, as most of the same issues still apply]

By James J. Gormley

On November 15th, 2007, home-run legend Barry Bonds was indicted for allegedly lying under oath to a grand jury about his use of performance-enhancing steroids.

In the New York Daily News coverage of the story, Victor Conte, founder of the Bay Area Laboratory Cooperative (BALCO) that allegedly supplied numerous world-champion athletes with performance enhancers, was quoted as speculating that “Bonds could have tested positive due to a contaminated dietary supplement.”

Right. Perhaps Conte was borrowing an excuse from nearby San Diego. On October 31st, The Canadian Press reported that San Diego Padres’ center fielder, Mike Cameron, was suspended for 25 games after testing positive a second time for a banned stimulant. Cameron reportedly said that he thinks he took a tainted supplement.

On October 5th, Olympic gold medalist, Marion Jones-Thompson, pled guilty to charges of making false statements to federal agencies in connection with two investigations, one of which was related to the BALCO steroid cases.

A Checkered Past
According to the Seattle Post-Intelligencer, the BALCO timeline extends back as far as 1988, when Conte was providing free blood and urine testing and dietary supplements to a group of athletes he referred to as the “BALCO Olympians,” whom he joined at the 1988 Summer Olympics in Seoul, Korea.

After 1996, Conte formed what he called the ZMA Track Club, which, according to the Seattle Post-Intelligencer,“served as a marketing tool and claimed among its athletes Marion Jones and Tim Montgomery.” According to the paper, “Bonds’ arrival in 2000 signaled even greater opportunities.”

According to USA Today, 2002 was when the federal investigation of BALCO began, followed by a raid of BALCO’s offices in September 2003 and a 42-count indictment against four men (including Conte) alleging a conspiracy to distribute anabolic steroids and misbranded drugs, in addition to money laundering.

In the midst of all of this, in February 2003, Baltimore Orioles’ pitcher, Steve Bechler, died due to “a constellation of risk factors,” according to Broward County medical examiner, Dr. Joshua Perper, including: “being significantly overweight and not well conditioned”; “not yet being acclimatized to the warm climate of Florida” and “having hypertension and abnormal liver function.”

These extremely important facts were not mentioned at the time by Rep. Henry Waxman (D-CA) when he used this case as leverage for his anti-supplement intifada now, were they? In fact, according to April 2003 comments by attorneys Marc Ullman and Seth Flaum that were submitted to the FDA regarding the agency’s proposed rule for dietary supplements containing ephedra alkaloids:

“This information was left out of many of the news reports that followed Mr. Bechler’s death and has never been acknowledged by any FDA official.”

Picking up the doping follies again in December 2004, grand jury testimony appeared in the San Francisco Chronicle in which the paper said Bonds “admitted to unknowingly using steroids during the 2003 season. In July 2005, Conte pled guilty to steroid distribution and money laundering. Reports emerged in January 2007, said USA Today, that Bonds tested positive for amphetamines during the 2006 season.

"Oh, Those Tainted Dietary Supplements" or The Dietary Supplement Excuse
Which brings us back to the present, where we apparently have entered a new age, the age of "The Tainted Dietary Supplement Excuse," an excuse that almost anyone now who is caught improperly using spiked products cooked up in some lab can apparently take advantage of.

Many of these product abusers would have us believe that they are hapless fools, doe-eyed innocent pawns of diabolical masterminds who nefariously sabotage the benign nutritional products that are foisted upon them. Hardly.

Maybe we should suggest that users of heroin could claim that they used an opium poppy extract unknowingly tainted with morphine?

Perhaps people busted for cocaine possession could claim that the Erythroxylon shrub extract they were taking was tainted with cocaine alkaloids?

Who cares about athletes exercising personal responsibility and playing by the rules when stadiums are packed to the rafters and team (or even national) glory is at stake? Isn’t it that much easier for coaches or commissioners to look the other way when championship rings or gold medals are being handed out?

It’s not about dietary supplements but about greed, money, politics and power. The pharmaceutical lobby is very powerful. The money at stake behind sports is staggering. Our need for sports heroes is also very compelling.

America needs a scapegoat. How convenient that dietary supplements continue to be easy targets. Why don’t we blame pharmaceuticals? At least, we know they harm and kill people in droves.

Oh right—sorry. Forgot about all the pharma ads in newspapers, magazines and TV and their stranglehold on Congress and the FDA.

We’ll have to come up with another idea.

Wednesday, February 3, 2010

Rick Kaiser to Head Up Sales for OmniActive Technologies

SHORT HILLS, N.J., February 3, 2010 - OmniActive Health Technologies today announced that Rick Kaiser has joined the company as Director of Sales.
In this role, Kaiser will be responsible for securing new accounts, managing sales activities including lead generation and trade show activity, and marketing the company's proprietary weight management and eye health ingredients. Kaiser brings more than 30 years of sales experience in both the pharmaceutical and nutraceutical industries.

"We are pleased to have Rick join the OmniActive team and feel that
his extensive industry experience and strong reputation will be invaluable as we continue to grow and strengthen our sales initiatives," noted Hiren Doshi, Vice President, OmniActive Health
Technologies. "We are confident in Rick's ability to effectively
communicate the health benefits and clinical science behind our ingredients and continue to expand our client base across North America."

Kaiser has held numerous executive sales and marketing positions at leading companies including Advana Science, Inc., Bioriginal Food and Science Corporation, Nutrition 21 and Bristol-Myers. He comes to OmniActive with solid experience in brand development, account
generation, sales force management and training, and marketing of natural ingredients.

About OmniActive Health Technologies:
OmniActive Health Technologies, Ltd. ( supplies a range of innovative, scientifically validated, active natural ingredients for healthcare, food and personal care applications. The company offers the world's first and only complete source of both free lutein and lutein esters, as well as a unique combination of lutein and zeaxanthin isomers, under its Lutemax(R) line of ingredients. OmniActive also offers the weight loss ingredient Capsimax(TM) Capsicum Extract, manufactured from the active principles of hot red peppers, as well as Capsimax(TM) Plus Blend, a proprietary blend containing Capsimax Capsicum Extract and other natural thermogenic and performance-boosting agents for use in a range of weight management and sports nutrition products. OmniActive has a wholly owned US subsidiary, OmniActive Health Technologies, Inc. in Short Hills, NJ, and conducts operations from its manufacturing, R&D and corporate facilities at Pune, Mumbai, Thane and Cochin, India. OmniActive's manufacturing facilities are certified for the quality and food safety management systems under ISO-22000(2005) and cGMP standards.


Press Contact:
Courtney Jacobs Morton
Integrated Marketing Group
P: 801-538-0777 x102