True/False Question
Consider the following statements made by members of the public on a website about a product called ‘Triple Flu Defense’ in the US.
Remember advertising to the public is allowable in the US.
The product is actually described by the company responsible for the website as ‘a unique homeopathic formula adjusted each year to combat current season’s flu viruses’
- “It really works – my husband didn't take the formula and got sick and I didn't. It has no side effects”
- “I’m one of the few people I know who didn’t get the flu this past year because of Triple Flu Defense”
- “I’ve been around people with the flu and haven’t gotten sick since taking Triple Flu Defense”
- “My son had no reactions and did not catch flu this year”
- “This product is of inestimable value in the prevention and mitigation of influenza”
Which of the following aspects do you think are important in considering the appropriateness of this website?
- Target audience ideally this would be targeting US citizens and that should be made clear
- None - as a homeopathic product the regulations don’t apply here the FDA disagreed that this could be considered a homeopathic product based on the nature of the claims being made
- Balance consider the claims about ‘no side effects’ – is any safety information given?
- Clinical trial data to support the claims patient testimonials can be powerful – but do they represent a fair reflection of the current body of evidence and typical responses to treatment?
- Exaggerated claims for example ‘inestimable value’
This was the subject of an FDA warning letter. Because of the nature of the claims being made the FDA said that this product should be regarded as a ‘new drug’ which needed to go through the full approval programme to establish its effectiveness and safety. The claims were not balanced – there was no safety information and no information about any possible side effects.
