Nutri Herb Inc – FDA Warning Letter, Aug 31, 2010

The FDA reviewed Nutriherb.net in August 2010 and determined that "Custom Advantage Chamomile," "Custom Advantage Co Q10," and "Custom Advantage Omega-3 Fatty Acids" 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). Therapeutic claims on the website, such as "Relieves ... inflammation" for Chamomile, "Cancer prevention" for Co Q10, and "Cardiovascular disease prevention" for Omega-3 Fatty Acids, establish their intent for disease cure, mitigation, treatment, or prevention, violating the Act.

These products are considered "new drugs" under section 201(p) because they are not generally recognized as safe and effective for their promoted uses, and they lack prior FDA approval as required by section 505(a). Furthermore, the products are misbranded under section 502(f)(1) as their labeling fails to bear adequate directions for use.

The letter emphasizes that this is not an exhaustive list of violations and that the firm is responsible for ensuring all marketed products comply with the Act. Prompt corrective action is required to address these violations and prevent recurrence. Failure to comply may result in enforcement actions, including seizure of products and injunctions. A written response detailing corrective steps and timelines must be submitted to the FDA Florida District Office within fifteen working days.