Natural Products Insider

JAN-FEB 2019

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 26 of 40

22 INSIDER January/February 2019 Divya Desai, CEO, Bioactive Resources LLC: A host of regulatory requirements help protect both supplement consumers and brands. A brand wants to be sure the contract manufacturer is a rock-solid performer in that arena. Ingredient integrity is also imperative to a formulation's ability to produce the outcomes required (and maintain the brand's reputation). Lastly, it's important to know a contract facility's real-time capabilities. Some are excellent with short-notice, quick access, while others are stable and dependable for the consistent re-order cycles. By vetting, a brand can ascertain all these important aspects and proceed with confi dence. INSIDER: How do contract manufacturers help supplement brands ensure they follow regulations for manufacturing and labeling? Heather N.D. Fairman, CEO, DF Guardian Consulting Inc.; independent consultant, EAS Con sulting Group LLC; independent advisor, SIDS DOCK/SIDS DOCK IWON: Anyone who manufactures, packages, labels or holds a dietary supplement is subject to federal regulations (21 CFR 111; 21 CFR 110/117 and the Food Safety Modernization Act [FSMA]). An own-label distributor and its contract manufacturer must develop a mutual commitment to compliance through transparency. A clearly defi ned quality agreement will help tremendously in providing support. Contract manufacturers that value the integrity and excellence of their processes and deliverables will take a vested interest in credibly ensuring their customers are supported in all areas of manufacturing and labeling. Griffi n: Brand owners as well as manufacturers have equal regulatory liability when it comes to labeling and claims, so it behooves contract manufacturers to either educate brands about the mutual requirements/liabilities, offer the services to ensure the necessary regulations themselves, or direct the brands to engage the services of a third party that can help ensure legal compliance. This helps ensure a healthy business relationship is maintained and all parties are committed to fi nding a prompt resolution when issues arise. McCutcheon: When selecting a contract manufacturer, brands need be clear at the outset about what they want to achieve with their products and where the product will sit in the market, since this will inform the regulations, manufacturing and labeling requirements. If some requirements are non-negotiable, for example gluten free, non-GMO (genetically modifi ed organism), etc., this needs to be communicated to the contract manufacturer upfront so that it can plan its operational efforts accordingly. The formulation and regulatory experience of the contract manufacturer also feeds into this, since contract manufacturers need to be able to quickly resolve manufacturing issues that arise—and adjust to ensure a successful product launch. Ung: The dietary supplement business has faced continual regulatory changes. It seems every year, auditors ask for more documentation or changes in procedures. A good contract manufacturer is aware of the regulatory environment and is proactive to notify its customers of changes (actual or potential). Contract manufacturers have their own regulatory teams that review product labels for compliance. However, brand owners should have their own legal/regulatory teams review/approve products, because the brand owner is ultimately responsible for its products. FDA will not accept ignorance or punting the responsibility to a brand's manufacturer when it comes to labeling compliance. INSIDER: How can contract manufacturers help brands increase their supply chain transparency, consumer trust and sustainability? Fairman: Through a process known as supply chain segmentation (SCS), contract manufacturers can work toward creating processes that encourage their raw material suppliers to be transparent with their ingredient content and documentation. With periodic meetings with the own-label distributors, contract manufacturers are more likely to ensure that the brand owners' needs are being met. As a result, the expectations of both the brand owner and consequently, its consumers, will be met. The contract manufacturer can commit to compliance and deliver quality products, which over time will result in successful and sustainable profi tability for each segment of the supply chain. Ung: Trust typically starts with transparency. If a contract manufacturer is transparent with formulations, batch records, certifi cates of analysis (COAs), etc., then the brand owner will have that information and decide what to share with its consumers to create trust. Some contract manufacturers are open and transparent about sharing this information, while others may not be willing. We are seeing more questions on supply chain beyond ingredient sourcing and sustainability. We are being asked about the ethics of the suppliers we use. Questions involve the environment, labor, work conditions, pay, humane treatment and anti-bribery/corruption practices. Desai: A lot of consumers are unaware of the recent FSMA rulings that were implemented to help support transparency and supply chain safety. A brand should feel assured its manufacturer is actively Contract Manufacturing: Best Practices Contract Manufacturing: Powders Convenient, easy to use and often boasting benefi ts in shelf life and bioavailability, powdered supplements are projected to experience a 10.8 percent CAGR from 2016 to 2024. Contract manufacturers experienced in powders are equipped to help address formulation concerns, test to specifi ed requirements and meet reasonable times to market. Download INSIDER's Contract Manufacturing: Powders digital magazine to learn more. Vol. 8, No. 17 August 2018 US$20.75 NOVEMBER 6-10 Expo Hall November 8 & 9 Mandalay Bay Las Vegas Contract manufacturing: powders Scan Here

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