I am getting concerned about the type of substantiation that the authorities are asking for with respect to our wellness products. To the best of my knowledge they have only been requesting this level of substantiation for PD products. I would like to better understand why there has been a dramatic change in their on-going requests for information to support claims. I am not aware of any changes to the regulations that require this level of support for wellness products.
For most of the wellness products, we will not have any support that mentions the product by name in the reports. As you know most of these products are supported by on our scientists' knowledge of ingredients, products, and nutritional requirements. We need to push back on these types of requests.
I would be more than willing to have a call if needed to better understand the requirements.