October 6, 2020
Brand owners must know specifications for their product’s testing, stability and ingredients.
A contract manufacturer’s “proprietary” undisclosed info won’t satisfy regulatory demand.
International components are subject to Foreign Supplier Verification Program (FSVP) specs.
What’s in your product and how did it get there? This logical question is really the tip of a regulatory iceberg. At present, FDA is looking deeper into the matters of the composition of foods and dietary supplements. The necessary information should be on file and readily available during these inspections, and answers to the questions posed constitute regulatory responsibility. This is especially true for own-label distributors whose physical relationship with their products is not entirely “hands on.” The requirement and subsequent expectation of FDA is that such marketers and/or distributors know the performance of the contracted parties with whom they work to deliver their product.
The particulars of what a contracted manufacturer does and what it uses in the products, along with how they are tested, are critical elements in the regulatory obligations. Blend these requirements at the brand owner end with the requirements for the manufacturer and it becomes a rather larger requirement than first appears.
Dependent on where a company is in the process of delivering product to market, strict regulatory requirements must be met. Reviewing these requirements can help a company know what to ask for (or sometimes, demand). And in some instances, making supply chain decisions involves the knowledge—and thus, disclosure—of what the product consists of, how it is made and how it is tested. Ultimately, the brand owner is required to know this information.
Although not new, the term transparency has come into vogue in recent years around product manufacturing, particularly in a contracted situation. The expectations haven’t changed; only the deeper dive into the operations being inspected. From the finalization of GMPs (good manufacturing practices) for dietary supplements, the information required has remained. Only because people are asking for it has it become a topic. Now that FDA is more commonly asking for it, the importance of this information takes on a whole different perspective. Additive to GMPs are requirements out of the Food Safety Modernization Act (FSMA) that must be noted, known and reviewed by the brand owner. This is nothing new.
Examples of the information required include knowledge of the specifications established for the finished product, inclusive of:
Methods employed for testing
The testing scheme itself
Stability of the product
Complete disclosure of foreign suppliers of any materials used in manufacturing, along with the approaches that the contract manufacturer uses in development of the specifications
Assurance that all test methods are fit for purpose
Complete disclosure of each ingredient and component used in the making of the product
All available information concerning the testing of each specific batch of product.
So where are the common shortfalls? Great question.
From the distributor (brand owner) perspective, consider something seemingly obvious: Are any of the ingredients in your product identified as blends? Or are they ingredient blends disguised as flavors? The exact, complete and unhindered information regarding the makeup of these “blends” is mandatory, along with the distinction from flavor systems. Not only from the standpoint of qualitative presentation, but quantitatively at least to the point of provision of a descending predominance by weight listing of the ingredients.
There can be no ambiguity about what each item in the product formula is. Information that a contract manufacturer considers “proprietary” doesn’t really cut it when it comes to regulatory demand. Complete transparency of one’s supply chain is the only solution. It may seem out of the ordinary that a contract manufacturer would refuse to disclose specifics of the formula being produced on your behalf, but this occurs more often than you might think. This is just the fundamental requirement—knowing precisely what is in the product you are purchasing in adequate detail to meet the regulatory requirements.
Another level down is the matter of the specifications for the products. Specifications are meaningless without identification and traceability of the qualified methods to be used in the testing to be performed. Oblique references to internal methods often do not suffice, and FDA will want to know and review the documentation that should be available for how the method meets the standards of “scientifically valid.” It is not enough to simply identify and acknowledge an internal method reference; the quality of the method (or its qualifications, as it were) must be reviewed and evaluated. This is an expectation out of the regulations and when a laboratory is audited as part of the manufacturing operations overall.
If a simple reference to a compendium (such as United States Pharmacopeia [USP] or FDA-Bacteriological Analytical Manual [BAM]) is used, the evaluation of what is actually done must be performed to account for any modifications employed to the compendial method in order to make it work for the particular product being tested. In fact, the testing of the finished goods, a requirement for the contract manufacturer, must include all specifications. If any testing is being skipped or “exempted” for any reason, that reason must be clearly documented with supporting data and conform to the requirements for applying such exemption.
A protocol cannot be arbitrarily written to reduce the testing needs without supporting data and evaluation as part of the overall supply chain qualification. The brand owner will ultimately find itself involved in a precarious situation with a whole bunch of legal and regulatory liabilities, if their contract manufacturer or suppliers do not conform to their applicable regulations.
Lastly, the other requirements out of FSMA come into play. Is the contract manufacturer obtaining any of the components used in your products directly from international sources? If the answer is yes, the Foreign Supplier Verification Program (FSVP) requirements must also be available to the brand owner for inspection to assure their compliance at minimum. This is just the tip of the iceberg, but the importance of having all of these areas covered in detail is the emerging expectation as FDA ramps up its inspection activities.
It’s more important than ever to comply based on the increasing enforcement actions of FDA. This reactive approach is typical of industry, but we are approaching another level of compliance expectation that should bring one and all back to the table to ensure compliance. The brand owner must insist on complete disclosure of those activities performed by their contract manufacturer in order to meet its own regulatory obligations.
Each day, the interpretation of the regulations by the regulatory authorities and the application of compliance enforcement gets more detailed while merely re-informing everyone of the obligations they perform. Gather the information, review it and insist on full transparency, ask a lot of questions and if you don’t know what questions to ask, get someone on your side who does.
As chief operating officer, Jim Lassiter oversees all consulting operations at REJIMUS, formerly 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.
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