Natural Options Corp – FDA Warning Letter, Dec 31, 2010

The FDA issued a Warning Letter to Natural Option USA Corporation on December 21, 2010, following a review of their website in December 2010. The product OsteOrganicCAL (a sea algae calcium compound with Vitamin D3) is promoted with therapeutic claims that classify it as a drug under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act).

The claims, including personal testimonials and "CASE STUDY ANALYSIS" under the heading "OsteOrganiCAL? CASE STUDY ANALYSIS," suggest the product is intended for the cure, mitigation, treatment, or prevention of diseases like osteopenia and osteoporosis, and for improving bone mineral density. Examples include claims of reversing osteopenia/osteoporosis, significant improvement in bone density tests, and preventing bone fractures.

These claims establish OsteOrganicCAL as a "new drug" under section 201(p) of the Act because it is not generally recognized as safe and effective for these uses. New drugs require prior FDA approval under section 505(a). Furthermore, the product is misbranded under section 502(f)(1) of the Act due to a lack of adequate directions for use in its labeling.

Natural Option USA Corporation is required to take prompt action to correct these violations and prevent recurrence. Failure to comply may result in enforcement actions, including seizure of products and injunctions. The company must respond in writing within fifteen