Natural Products Insider

SEP-OCT 2017

INSIDER is the leading information source for marketers, manufacturers and formulators of dietary supplements, healthy foods and cosmeceuticals. Since 1997, INSIDER has been serving the needs of the global nutrition industry.

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Page 62 of 160

54 INSIDER September/October 2017 Are there any environmental contaminants present? Are there any allergens present in the raw material? What is the shelf life and required storage conditions? What is the bio-burden, e.g., yeast, mold, etc.? Is the material kosher or halal or both? If so, provide written verifi cation from the responsible agency. Is the manufacturing facility appropriately and currently licensed? Has the manufacturing facility ever experienced a recall or product failure? If so, details and corrective action plan copies would be mandatory. Do you provide product liability insurance naming the entity as additional insured? What perils are insured, and at what levels? What is the ownership structure of the company? Will the company provide audited or reviewed fi nancial statements? Will you provide an organizational chart showing contact data for the essential personnel? Can we initiate a site visit for a vendor qualifi cation audit? These are 15 separate questions of signifi cance, and none of them include the query that is most often the show-stopper, namely, "What is the price?" We all know there is enormous pressure on companies to maintain profi tability, but there are correct ways of doing this, and succumbing to the lowest-price bidder as the primary decision point is often followed by signifi cant regret when something goes wrong. Recalls in our industry for products contaminated with Salmonella or other pathogens are expensive and damaging to brand equity and industry credibility. Product seizures for misbranding or placing harmful synthetic chemicals that mimic sexual enhancement agents or stimulate rapid weight loss will continue until all of industry recognizes that doing the right thing is the better way. Until then, caveat emptor—let the buyer beware. If a producer in the dietary supplement space fails to follow the basics of GMP requirements when qualifying and sourcing raw materials, it's often the fi rst step in what can become a costly, embarrassing and negative experience. Mark A. LeDoux is founder, chairman and CEO of Natural Alternatives International Inc. (, an organization with facilities in the United States and Switzerland engaged in the research, design and manufacture of nutritional supplement programs and products for multinational clients. LeDoux is immediate past chair of the Council for Responsible Nutrition (CRN) and current chairman of the CRN- International. LeDoux has been a member of the Natural Products Association since 1980 and serves on its board of directors. He is also a recognized participant of the Codex Alimentarius Commission. 6982 Bandini Blvd., Los Angeles, CA 90040 | Toll Free: (800) 360-SGTI | Phone: (323) 726-0700 | A Singular Focus We make softgels. Various shapes, sizes, and colors. Custom and stock formulas. Solvent-free. That's all we do. In a GMP-certified U.S. facility. We do one thing and we do it well. By choosing us as your softgel contract manufacturer, you can concentrate on what you do best. If we may have your attention for a moment, we'll make you the center of attention. Contact us today. Delivering custom and branded softgels, naturally. ™ Contract Manufacturing: Ingredient Sourcing

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