Natural Products Insider

NOV-DEC 2018

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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56 INSIDER November/December 2018 At the start of a partnership, a contract manufacturer and the own label distributor should review regulatory requirements. The responsibilities of the contract manufacturer are to qualify its supplier, establish specifi cations for the material and test against those specifi cations. The responsibility of the brand holder is to know how well its contractor does its job. Transparency is increasingly important to both parties. The number of individual ingredients purchased by a contract manufacturer is enormous. Expeditious purchase of materials frequently drives the purchase toward brokers rather than directly from a specifi c supplier. This approach makes good business sense but comes potentially short of fulfi lling transparency obligations. The contract manufacturer should know the ingredient supplier and the details of the ingredients. The requirement that the material be produced in a facility that is registered with FDA is a bare minimum. However, it's usually not a priority of a contract manufacturer to evaluate the performance of material suppliers. Then the complicating, yet clarifying, factor is the enforcement of regulations set forth in the Food Safety Modernization Act (FSMA) regarding both domestic and foreign manufactured food items. Once the material is received, it should be tested against meaningful quality Ingredient Transparency Beyond Legal Requirements by Jim Lassiter Acid Resistant Vegetable Capsules ) ' u n. , u, ' . ' AN EXCELLENT CHOICE FOR DELIVERY OF ACID-SENSITIVE ACTIVE INGREDIENDTS . . . <> . 863DWHQW See us at SSW • Booth #1347 specifi cations and the contract manufacturer should document the tests, whether in the form of a certifi cate of analysis (CoA) or an actual listing of the results. For the brand holder, each requirement outside of the regulatory requirements is optional, but potentially important. Regulations don't require transparency between the two parties regarding specifi cs of the delivery or origin of the material. Once performance is determined, routine re-evaluations are necessary to ensure the continuing good practices of the contractor, but the disclosure of information is not dictated by transparency. The following is a real-world example. If contract manufacturer A purchases 25 different items from one broker who, in turn, uses 50 different sources for these 25 items, that imposes a large amount of information that remains potentially available to the brand holder. The regulatory obligation is that contract manufacturer A affi rms the acceptability of the supplier (not just the broker) and that customer B has knowledge that contract manufacturer A follows the applicable regulations. Customer B may wish to know the country of origin of an ingredient or all ingredients, or it may wish to know the specifi cs of the supplier. This is optional information and may be disclosed as such—optionally. Customer B is interested in whether the ingredient is what it says it is, is not contaminated and is not adulterated, all of which are solved by contract manufacturer A performing its regulatory obligations. Separate agreements beyond that scope are separately generated and mutually agreed to. Contract manufacturers can deliver this information to the brand holder in several ways: through CoAs to affi rm the identity, purity, strength and composition of the ingredient based on testing; through the information provided by the supplier's CoA; or through other means that demonstrate the regulatory obligations are met by the contract manufacturer. The information regarding the specifi c source of an ingredient contained in a product made for the customer is a separate matter between the two parties. As chief operating offi cer, Jim Lassiter oversees all consulting operations at Ingredient Identity (ingredientidentity.com). He has more than four decades of experience in quality control (QC), and government and regulatory affairs throughout the pharmaceutical, dietary supplement and natural product industries with organizations such as Nutrilite, Robinson Pharma Inc., Irwin Naturals, ChromaDex, American Herbal Products Association (AHPA) and Council for Responsible Nutrition (CRN). A respected author and speaker, Lassiter has served on numerous industry and trade boards. Contract Manufacturing: Supply Chain Transparency "We know what's in our Cheerios and in our retirement accounts because the law requires disclosure." —Barton Gellman, American journalist

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