December 17, 2018
“We know what’s in our Cheerios and in our retirement accounts because the law requires disclosure.” – Barton Gellman, American journalist
The business of contract manufacturing involves the management of potentially hundreds of individual ingredients, each with its own testing requirements. Brand owners must ensure these tests are conducted. Now that the obvious is out of the way, the matter of ingredient transparency must be addressed.
At the start of a partnership, a contract manufacturer and the own label distributor should review the regulatory requirements. The responsibilities of the contract manufacturer are to qualify their supplier, establish specifications for the material and test against those specifications. The responsibility of the brand holder is to know how well its contractor does its job. Transparency is increasingly important to both parties. The challenges are outlined by looking at the two sides individually.
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 specific supplier. This approach makes good business sense but comes potentially short of fulfilling 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 specifications and the contract manufacturer should document the tests, whether in the form of a certificate 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 specifics 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.
Let’s provide 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 affirms 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 the ingredients, or it may wish to know the specifics 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 affirm 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 that the regulatory obligations are met by the contract manufacturer. The information regarding the specific source of an ingredient contained in a product made for the customer is a separate matter between the two parties.
As chief operating officer, Jim Lassiter oversees all consulting operations at Ingredient Identity. 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.
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