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Wednesday, September 9, 2009

It's Time for an Attitude Adjustment

BREAKTHROUGHS

Score One for the Good Guys
September 9, 2009

By Melanie Segala
Managing Editor, Total Health Breakthroughs

I’m a big believer in the value of nutritional supplements.  Knowing how much better I feel when taking them, I get a little nervous when I hear that the government is giving honest supplement companies a hard time.  What would we do if they were all run out of business?

That’s why I was happy to read about a reputable supplement company that did everything right and scored a big victory over unfair government bullying tactics.   

I was reminded of David taking down the mighty Goliath… when Goliath felt like pushing his weight around.

Goliath in this case is the FTC, the government agency that works closely with the FDA to monitor product advertising.   In 2007, the agency placed a $24 million fine against LaneLabs of New Jersey.  Their motion charged that the company was making unsubstantiated claims for two of its supplements —AdvaCal and Fertile Male.    

Among the company’s supposed offences was the charge that the products did not live up to their advertised claims.  This resulted in “injury to consumers.” The company was also accused of misrepresenting the results of clinical trials on both products. 

But as shown in a New Jersey courtroom recently, nothing could have been further from the truth. 

LaneLabs had a compliance officer on staff when both products were developed and manufactured.  This individual ensures that the company follows all government regulations in regard to manufacturing and advertising its products.   The compliance officer also sees to it that all internal procedures are correctly followed.   These steps ensure the safety and effectiveness of the product.  

The company also consulted with experts to interpret all the scientific data during the formulating process.  These experts were physicians, researchers or professors of medicine.  During courtroom testimony, the judge found them to be “credible and knowledgeable in their respective fields of expertise.” 

He added that the testimony of LaneLabs’ experts versus the FTC’s regarding the effectiveness of the products, came down to a difference of opinion and not a matter of right and wrong.  In fact, he noted that despite the FTC’s charges, their own experts did not even claim in court that the products in question were not effective or a health risk to the public.

And regarding charges that consumers had complained or were harmed by taking the products? The FTC had no proof of either.

Another point was considered by the judge in his ruling.  LaneLabs introduced AdvaCal in 2000 and Fertile Male in 2003.  Yet the FTC waited until 2007 to file their motion against the company. 

According to the judge, the FTC was totally out of line in filing a motion against the company years after the products were introduced.  Not only that, but the agency never contacted LaneLabs stating that they might be doing something wrong.   

How could they correct something that they weren’t even told was wrong?  And how dangerous could the products have been if it took the agency 4+ years to get around to a fine? 

In dismissing the case last month, the judge ruled that contrary to the FTC’s claims, LaneLabs did everything possible and took all “reasonable steps” to comply with government regulations.    

While we can plainly see that this is true, what about the FTC and the FDA?  They did do something wrong in bringing what amounts to false charges against an honest company. 

Both agencies monitor the private sector, especially when it comes to nutritional supplements.  But who monitors them?  Is there any penalty they have to pay in what amounts to an abuse of power?

This case should set a strong precedent.   Baseless lawsuits and fines on the whim of government regulators will not hold up in a court of law.  Uncle Sam needs to back off on their senseless attacks of supplement companies under the pretense of protecting the people.

Bravo LaneLabs and Judge Dennis Cavanaugh.  You did the right thing and we all won a victory.

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