FDA WARNING_LETTER - Dr. Christopher's - December 31, 2010

The FDA issued a Warning Letter to Josh Scott regarding products promoted on www.drchristophers.com and www.herbshopconnection.com. An FDA review in December 2010 found that products including "Bilberry Eye Capsule," "Cayenne Pepper Extract," and "Hawthorn Berry Heart Syrup" are promoted for conditions that classify them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act).

The therapeutic claims on the websites, such as preventing glaucoma, treating cancer, or addressing heart disease, establish these products as drugs intended for diagnosis, cure, mitigation, treatment, or prevention of disease. These claims violate the Act.

Furthermore, these products are considered "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective for their claimed uses. Marketing new drugs without prior FDA approval, as required by section 505(a), is illegal.

Additionally, the products are misbranded under section 502(f)(1) of the Act because they are offered for conditions not amenable to self-diagnosis and treatment by laypersons, meaning adequate directions for safe use cannot be provided.

The FDA requires prompt corrective action within fifteen working days, including written notification of steps taken to correct violations and prevent recurrence. Failure to comply may result in regulatory actions such as seizure or injunction.