FDA WARNING_LETTER - Agora Publishing Inc - December 31, 2011

The FDA issued a Warning Letter to Agora Publishing, specifically addressing products "PureImmune Plus" and "Healthy Aging" promoted on www.northstamutritionals.com. The FDA reviewed the website in December 2011 and determined that therapeutic claims made for these products cause them to be unapproved new drugs and misbranded under the Federal Food, Drug, and Cosmetic Act.

The products are deemed drugs because they are promoted for the cure, mitigation, treatment, or prevention of disease. Examples of claims for "PureImmune Plus" include preventing cancer and having anti-inflammatory properties. Claims for "Healthy Aging" include balancing blood sugar, improving insulin sensitivity, maintaining glucose tolerance, improving cholesterol, and fending off blood vessel problems.

These products are considered "new drugs" because they are not generally recognized as safe and effective for their claimed uses and lack prior FDA approval. Furthermore, they are misbranded as their labeling fails to bear adequate directions for use, and their intended conditions are not amenable to self-diagnosis and treatment by laypersons.

Agora Publishing is required to take prompt action to correct these violations and prevent recurrence. Failure to comply may result in regulatory actions like seizure or injunction. A written response detailing corrective steps, including documentation, is required within fifteen working days.