As the FDA (Food and Drug Administration) closes in on neutraceutical regulation and clinical and regulatory submission and rigor, neutraceutical investors require more product due diligence prior to making significant investments in neutraceuticals. The analogy used with investor clients is investing in neutraceuticals without the proper due diligence performed by qualified experts is like buying a property without a property inspection to ensure that the transaction is valued with investor ROI factored in.

Due diligence must be performed by a group of experts who examine all data, documentation, manufacturing, formulation, efficacy and safety claims, QC/QA (Quality Control/Quality Assurance) and FDA requirements of the respective neutraceutical. It is anticipated by the industry that the FDA will soon begin regulating neutraceutical companies and products. Therefore, the ROI-driven neutraceutical investors have a direct interest in product QC/QA, product development, formulation, manufacturing, advertising claim substantiation and most importantly, consumer safety.

Recently, I was asked to perform a quick due diligence on a neutraceutical product. What did I examine at first blush?

• clinical and medical claims
• clinical and medical use
• product claims
• product revenue
• product formulation
• miss-use or abuse issues
• disclaimers
• proprietary product documentation
• confidentiality/non circumvent agreements
• SEC documentation
• private or public company profile
• financial documentation
• financial disclosure
• revenue stream
• purchase invoices
• “the need”
• “the perception”
• P&L
• shipment considerations
• publication, abstract, literature, advertising, marketing, infomercial, brochure, statements
• manufacturing license
• manufacturing process and agreements
• GRAS list for import and export of product substance
• CMC - chemistry, manufacturing and controls
• “rights” to active ingredient
• product line of the company
• FDA correspondence
• claim substantiation
• claim longevity
• claim integrity
• clinical studies to support claims
• consumer safety
• consumer adverse reports pertaining to product use
• endorsements
• testimonials
• data
• documentation
• company history and background information
• company operations and staff
• Officers of the company, CEO, CFO, COO, CSO, CMO, etc.

The “quick” due diligence performed for the neutraceutical in question was essentially a snapshot of a QC/QA, “check-list audit” process and procedure that would be required by FDA for a drug, device, biologic, vaccine, technology - similar, indeed.

The need for due diligence is clear for the FDA and the investor. The process, procedure and audit type is dependent on the neutraceutical and the claim. Whether FDA or investor, quality is a must. Assurance of subject/patient and/or consumer safety is critical.

Diane L. Mauriello, Ph.D., President of Dante Resources, Inc. a clinical research organization with decades of successful regulatory submissions without a single refusal to file. Diane and her colleagues are preparing to deliver clinical research webinars on topics related to clinical trials and successful regulatory submissions.