“MacuHealth believes challenged claims are thoroughly supported by the multitude of peer reviewed, published scientific studies” but NAD review on Vision Elements challenge finds firm’s research doesn’t support its claims.

“Choosing which claims to make,” an advertiser “affects the amount of substantiation required. A structure function claim, supports digestive health, may require a different level of substantiation than if you choose to make the claim prevents diarrhea,” says FTC attorney Christine DeLorme.

“We've had several citizen petitions. We can't ignore the data that are out there and are very new since the last time FDA had looked at this back in 2007,” says FDA OTC drugs office director Theresa Michele.

FDA drug user fee program chief tells OTC industry stakeholders accurate information in electronic Drug Registration and Listing System is key to setting annual facility registration user fee rates. CDER publishes warning letters to US retailer and a South Korean manufacturer noting noncompliance with eDRLS requirements.

As authors of JAMA study say theirs and others' research might influence regulatory policy on e-cigarettes’ use in smoking cessation, FDA publishes latest batch of warnings to businesses selling the products without pre-market approval required from the agency.

Trade group ask FTC to withdraw notices, arguing it is attempting to impose substantiation standard prohibited under FDA regulations for supplement manufacturing and marketing and are inconsistent with its own as well as FDA guidance