Saturday, January 30, 2010

Neutraceuticals - Due Diligence - FDA Regulatory Scrutiny - Investor ROI

As FDA closes in on neutraceutical regulation and clinical and regulatory submission and rigor - investors, with today's economic environment require more due diligence pertaining to the product, prior to investment. Due diligence, is performed by a group of experts who examine all data, documentation, manufacturing, formulation, efficacy and safety claims, QC/QA, FDA requirements of the respective neutraceutical. In the case of FDA - someday soon, neutraceutical companies and neutraceutical products will be regulated to some degree. For the interested investor, ROI is important, however, as well, directly relates to product QC/QA, product development, formulation, manufacturing and a twist on advertising, marketing - and consumer safety essential.

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. Ensurance of subject/patient and/or consumer safety is critical.

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