Any successful relationship requires an element of honest transparency to be mutually beneficial, and this is essential in the relationship between a contract manufacturer and brand owner. For clearly communicated transparency, these aspects should be addressed:
The partnership between the contract manufacturer and the dietary supplement brand owner must have transparency at all levels of the relationship. The first and foremost issue in this partnership is consumer safety. Multiple testing and assessments ensure consumer safety. Safety is about what is in the product as much as what is not in the product. Safety ultimately determines how a product interacts in the body, and this is influenced by storage, manufacturing and handling conditions as much as the raw materials.
Brand owners must be actively involved in how a product is made and tested in order to communicate this information to consumers, who are becoming increasingly aware of the ingredients they are consuming, as well as manufacturing’s role in safety.
Good Manufacturing Practices
Beyond ethical responsibilities, brand owners and contract manufacturers are required by law to comply with GMPs (good manufacturing practices), which include required testing to determine identity, composition, strength and purity. Furthermore, GMPs require that products be made in a process that is documented and reproducible at every step of the manufacturing process, from the quarantine of incoming material to testing the identity of material and its purity at every stage of manufacturing through finished product analysis.
Cleaning and maintenance of equipment is also required to prevent cross-contamination. Proper storage, personnel hygiene and correct selection of raw material and finished product testing is left up to the manufacturer by FDA, but testing must include organoleptic, microscopic, macroscopic and chemical analysis.
In addition, the testing methods chosen by the contract manufacturer must be the most suitable method available to determine the identity and composition of materials and finished products. GMP is the minimum manufacturing requirement in the United States, and a prospective brand owner should check whether a contract manufacturer has higher certification(s), and also find out the name of the certification(s).
GRAS Status Considerations
The distinction between functional foods and beverages and conventional is becoming blurred, and brand owners are increasingly turning to GRAS (generally recognized as safe) ingredients for further regulatory protection due to regulatory uncertainty. This includes filing papers for self-affirmed GRAS affirmations, which requires testing entirely on the part of the brand owner and scientific literature to provide complete long- and short-term animal (where possible, human) safety and toxicological data, which is then reviewed by an independent scientific safety panel. Historical usage data should be included when appropriate, particularly to show that the ingredient being affirmed has been used as food or is in the food chain supply; otherwise new dietary ingredient (NDI) information must be filed with FDA.
Awareness of Laws
The brand owner and contract manufacturer need to be aware that although DSHEA [Dietary Supplement Health and Education Act of 1994] can only be changed by an act of Congress, the way FDA implements the law has changed over time. Also, implementation methods may vary from region to region, so it’s crucial to stay informed. The way FDA enforces the new dietary ingredient (NDI) part of the law is evolving, so manufacturers need to stay informed in order to maintain regulatory compliance.
In California, Proposition 65 was enacted in 1986 to limit the presence of heavy metals, which, if exceeded, requires a label warning about carcinogens being present in a given product. Those limits are often far below what FDA sets, requiring manufacturers to meet a far lower level for that one state in order to avoid a class-action lawsuit.
Risk Assessment Considerations
The risk assessment of contaminants is a responsibility of the contract manufacturer and the brand owner, and it can be summarized by certain rules. Risk characterization integrates and summarizes the following: exposure characterization, dose-response assessment and hazard identification.
Compromises that occur during storage and production environments may require further testing to meet GMP requirements. Regulations require contract manufacturers to recognize and test for the presence and levels of microorganisms that could grow during particular stages of manufacturing processes.
Transparency to the consumer is an important consideration, and test results should be published in printed materials. It is the responsibility of contract manufacturers and brand owners to decide these issues jointly. Publication of safety testing builds consumer confidence and helps sales efforts in an increasingly consumer-oriented marketplace. GMP testing requirements, certificates of analysis and higher third-party accreditations and updates should be posted on publicly available materials in a joint effort between the brand owner and manufacturer. A third-party certificate of analysis verification on labels is a further option that should be discussed by both parties, with emphasis on third party.
Correct labeling is also the joint responsibility of the brand owner and contract manufacturer. All ingredients must be listed correctly with the common name and Latin binomials when appropriate. Proprietary blend labeling requires the listing of ingredients in descending milligram order, and its correctness and the accuracy of any changes fall on the shoulders of both parties. Inaccurate labels constitute misbranding, which is illegal and therefore actionable by FDA.
Accuracy in marketing statements is the responsibility of the brand owner for following FDA and FTC rules, but they depend upon the contract manufacturer for correct additive, coloring and excipient ingredient statements. Any changes in formulation must be accurately stated on the label, and transparency of substitution of ingredients falls on the shoulders of both parties.
FDA regulations allow for structure-function claims on printed or online dietary ingredient descriptions. They prohibit claims of “preventing, treating, mitigating or curing" any diseases. The problem facing brand owners, and to some extent, contract manufacturers, is the gray area that falls between disease intervention and structure-function claims. It is the responsibility of the brand owner to ensure that qualified regulatory personnel review and approve all statements made regarding dietary supplements, and if there is a question, a regulatory attorney should absolutely be consulted. Also, the contract manufacturer is not immune to liability because he is placing the product labels on the finished product in most manufacturing situations.
Perhaps the most important component that is essential to meet all of these goals is clear, regular and honest communication, which is vital for a successful and sustainable relationship.
For more information on fostering successful partnerships, check out INSIDER’s “Contract Manufacturing: Transparency in Partnership" Slide Show.
Shaheen Majeed is marketing director for Sabinsa Corp., where he represents the company’s substantial portfolio of proprietary nutritional and cosmeceutical ingredients.