Natural Products Insider

JAN-FEB 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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30 INSIDER January/February 2018 Acid Resistant Vegetable Capsules ) ' u n . , u, ' . ' AN EXCELLENT CHOICE FOR DELIVERY OF ACID-SENSITIVE ACTIVE INGREDIENDTS . . . <> . BioCaps Enterprises, Inc. • US Patent 9452141 INSIDER: What outside resources are available to help brand owners evaluate a potential contract manufacturer? Kaufman: NSF International's website ( and UL's website ( offer information and contacts about GMP-inspected companies. Brands can also fi nd good information on the Natural Products INSIDER website; and trade organizations such as the Council for Responsible Nutrition (CRN), the American Herbal Products Association (AHPA) and the Natural Products Association (NPA). And fi nally, brand executives should attend tradeshows and industry conferences, such as SupplySide West and East, and the Natural Products Expos. Finamore: Brands have several ways to determine or vet the suitability of a contract manufacturer, including trade references, searches of FDA or other government databases, consultants and memberships in prominent quality organizations established for industry (such as the Global Retail Marketing Association [GRMA]) and/or certifi cations from accredited audit bodies. While not all-encompassing, these offer a good starting point to understand the basic character of the organization. Fairman: Brand owners that do not have experienced and/or qualifi ed in-house quality personnel capable of handling the evaluation process to partner with a contract manufacturer should consider hiring a consulting fi rm capable of providing this expertise. Other available resources include trade association information, meetings, seminars (e.g., SupplySide West education and Natural Products Expos), credible industry articles and online audit lists. However, there is no substitute for qualifi ed and experienced help. Arthur Radcliffe, consumer health & nutrition business development manager, Capsugel- Lonza: A brand should request references from a manufacturer's other customers to determine if it has the level of expertise necessary in the marketplace in which the brand is working. For example, if a brand is creating a product for distribution in the mass-market channel, does the manufacturer know the regulations for such things as labeling and shelf life? The contract manufacturer needs to understand the rules of the game. INSIDER: What are a brand owner's responsibilities to ensure GMPs are met when a third-party manufactures its supplements? Fairman: Brand owners are ultimately responsible to ensure all applicable cGMPs have been met with regards to whenever or however a contract manufacturer manufactures its supplement products. Should a brand owner be in doubt about this or not consider themselves culpable in such instance, rest assured the Federal Food, Drug, and Cosmetic Act (FD&C) makes clear the prohibition of "any 'person' to introduce or deliver, or cause the delivery or introduction, into interstate commerce of a dietary supplement that is adulterated for failure to comply with dietary supplement cGMP requirements" [see SEC. 402. [21 U.S.C. 342]. Akand: FDA 21CFR111 compliance is not the sole responsibility of the third-party contract manufacturer. In addition to having copies of a fi nished product CoA [certifi cate of analysis], FDA expects the brand to have copies of batch production records (BPR), master manufacturing records (MMRs), and other testing supporting data to ensure product identity, purity, potency and composition for all products being introduced to the stream of commerce. It is also suggested the brand owners occasionally send their product out to an accredited third-party analytical lab to confi rm fi nished product is meeting label claims. Cusick: The brand owner bears the burden of confi rming GMPs are met. This is achievable via audits of the contract manufacturer's facility and engaged dialogue with the contract manufacturer's staff. Finamore: Industry is fi nally understanding the establishment of a contractual relationship involving supply agreements, quality agreements, product specifi cations, and as well as an integrated quality system between manufacturer and brand owner are now basic requirements for any relationship. Additionally, some brand owners still erroneously assign their responsibilities to the Contract Manufacturing: Best Practices A brand should request references from a manufacturer's other customers to determine if it has the level of expertise necessary in the marketplace in which the brand is working . Ñ Arthur Radcliffe, consumer health & nutrition business development manager, Capsugel-Lonza

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