Natural Clinical Trials Network
“Competent Scientific Evidence” Protects Your First Amendment Rights
I’ve set up the Natural Clinical Trials Network with my co-trustee, Ralph Fucetola JD and biochemist Robert Goodman, PhD, to allow natural product companies, especially innovative smaller or start-up companies, develop clinical substantiation for lawful claims.
If your company is ready to test your flagship natural products for general safety and benefit, we have the expertise to work with you, facilitating development of the protocols and substantiation strategies that can support DSHEA, Medical Food, cosmetic or biofeedback device claims.
Contact Dr. Goodman at: email@example.com and he will coordinate with us.
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A note from Counsel Ralph:
The Supreme Court has clearly ruled that people have a right to truthful commercial information[Thompson v. Western States Medical Center - 01-344, decided on April 29, 2002 - 535 U.S. 357]:
“If the First Amendment means anything, it means that regulating speech must be a last – not first – resort.”
“We have previously rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information.”
“Even if the Government did argue that it had an interest in preventing misleading advertisements, this interest could be satisfied by the far less restrictive alternative of requiring each [product] to be labeled with a warning that the [product] had not undergone FDA testing and that its risks were unknown.” – Justice O’Connor
It is useful to recall the 1996 comments of FTC Commissioner Starek, at the National Infomercial Marketing Association (comments the FTC maintains on its web site). He explained the issue to which the Court in Thompson v western States alluded — preventing misleading advertisements.
“As many of you know, the FTC is charged with protecting consumers from unfair or deceptive acts or practices. In advertising and marketing, the law requires that objective claims be truthful and substantiated. The FTC does not pursue subjective claims or puffery — claims like “this is the best hairspray in the world.” But if there is an objective component to the claim — such as “more consumers prefer our hairspray to any other” or “our hairspray lasts longer than the most popular brands” — then you need to be sure that the claim is not deceptive and that you have adequate substantiation before you make the claim. These requirements apply both to explicit or express claims and to implied claims. Also, a statement that is literally true can have a deceptive implication when considered in the context of the whole advertisement, even if that implication is not the only possible interpretation.”
“The substantiation requirement exists because every time an advertiser makes an objective claim, the advertiser also implies that there is a reasonable basis for the claim. This reasonable basis is substantiation. What constitutes a reasonable basis for a particular claim can vary, depending upon the nature of the claim, the product, the consequences of a false claim, the benefits of a truthful claim, the cost of developing substantiation for the claim, and the amount of substantiation that experts in the field believe is reasonable. Health and safety claims generally require competent and reliable scientific evidence. And if a marketer makes a representation that a claim has a particular level of support — for example, “clinical studies prove…” – the law requires at least that level of substantiation.”
Thus, Commercial Speech, if properly substantiated, is protected by Constitution and Law. As Justice O’Connor intimates, properly worded disclaimers and warnings are the preferred method for ensuring that Commercial Speech is truthful and protected. The Supreme Court decision in Thompson supports the lower court decision in Pearson.