The Connecticut-based company has been using “commercial claims” based around green tea, qualified health claims the FDA issued in 2005, but was targeted by the FDA in February for doing this, prompting its current action. The FDA said the company’s Tea for Life brand was making unauthorized drug claims and ordered it to justify or amend its claim making.
Fleminger’s subsequent complaint, lodged in the US District Court for the District of Connecticut, accuses the FDA of violating principles of free speech enshrined in the First Amendment by forcing it to use the, “government’s speech or none at all.”
It says the FDA is forcing potential claim-makers into, “remaining silent, or risking adverse action for its own commercial speech in violation of the First Amendment”.
The action states the FDA failed to use the, “least restrictive means of preventing any alleged deception of consumers who choose to purchase [Plaintiff’s] green tea.”
The action follows a recent Washington DC court verdict that found in favor of the Alliance for Natural Health USA, Durk Pearson and Sandy Shaw, and the Coalition Against FDA and FTC Censorship who sued the FDA over qualified health claims.
The court said FDA disclaimers for selenium claims in relation to certain cancers and respiratory and digestive health benefits must be redrafted.
According to a blog written by Alexander Varond and Diane McColl at Washington DC-based Hyman, Phelps and McNamara a similar verdict, “would send yet another strong signal to the agency that FDA needs to revamp its strict approach toward food and dietary supplements qualified health claims.”
Suppression of commercial speech
But New York-based food and drug attorney, Marc Ullman, from Ullman, Shapiro and Ullman, said the kind of claim-making that had prompted the FDA to issue a warning letter to Tea for Life, would be difficult to defend in a court of law.
These included claims that Tea for Life could improve cancer treatments, act as an antiviral agent and battle Alzheimer’s and Parkinson’s disease.
“While the latter claims might fit within that health claim box, it does not appear that the company ever requested promulgation of a regulation relating to Alzheimer’s or Parkinson’s diseases,” Ullman said.
“That would seem to be a condition precedent to any type of valid challenge to FDA on those claims.”
The fact a claim was not misleading did not necessarily validate its existence in the marketplace, he added.
“It is well settled case law that the US Government can suppress commercial speech, even if arguably truthful, where there is a compelling public interest in doing so,” Ullman said.
“There seems to be a movement within the industry espousing the idea that if something is true, supplement companies should be able to say it. This concept, however, simply ignores the fact that what you say about your product can make it a drug and that the Court’s have repeatedly upheld FDA’s authority to regulate drugs.”
Jonathan Emord, from Emord and Associates in Virginia, highlighted the 1999 case in which the FDA was first requested to alter qualified health claim disclaimers, Pearson v Shalala.
“The FDA has yet to comply with the constitutional mandate given it in Pearson v Shalala that it favor disclosure over suppression and rely on succinct and accurate disclaimers to eliminate misleadingness. Every act of FDA suppression stemming from its unconstitutional approach from 1999 to the present is unconstitutional, including this one.”
The FDA-approved qualified health claims for green tea are:
- “Two studies do not show that drinking green tea reduces the risk of breast cancer in women, but one weaker, more limited study suggests that drinking green tea may reduce this risk. Based on these studies, FDA concludes that it is highly unlikely that green tea reduces the risk of breast cancer.”
- “One weak and limited study does not show that drinking green tea reduces the risk of prostate cancer, but another weak and limited study suggests that drinking green tea may reduce this risk. Based, on these studies, FDA concludes that it is highly unlikely that green tea reduces the risk of prostate cancer.”