Manufacturing and selling dietary supplements can be a complicated challenge. Proper manufacturing techniques and processes, 'clean' and correct labels, as well as compliance to GMPs, testing, FTC and other regulations can be daunting tasks. Over the coming months, industry expert Brian Frisby will explore various topics dealing with manufacturing, marketing, testing, regulatory and GMP compliance within the dietary supplements industry. In this first article, he considers the likely effect of the new GMPs.
After almost 13 years of waiting and contemplating, we finally have current Good Manufacturing Practices (GMPs) for the Dietary Supplements (DS) industry. The DS industry now has its own set of 'rules' to live by. Critics in government and the media can no longer claim that the DS industry is not regulated or 'controlled.' Of course, they will continue to try and make this claim, but with some qualifications.
During the coming months, many people will be analyzing the new GMP regulations that the Food and Drug Administration (FDA) is ready to enforce. These will have far-reaching effects on the industry, the products produced and marketed, and the associated compliance costs. Although I certainly can't claim to be the final authority on interpreting GMPs, I offer my personal viewpoints in this article.
First and foremost, it is vital to understand one important concept: the GMPs are the regulations by which the industry must now live. Some individuals and companies within the industry have the misunderstanding that the GMPs are only the FDA's recommendations, or suggestions or good ideas. In my opinion, this is false and dangerous thinking! The GMPs are the actual written regulations that will be enforced to ensure that dietary supplements are manufactured, packaged, stored, labeled, and marketed in a consistent manner to ensure the quality of the product.
They outline the manner in which many operations take place within a company making or selling dietary supplements. Product design, raw material sourcing and testing, storage facilities for raw materials and finished goods, record keeping, product traceability, quality assurance methods, and product controls are only some of the areas the regulations cover. Compliance is essential for all companies that manufacture, package, label or hold dietary supplements for sale in the United States. Failure to comply with the GMPs can result in product seizures, recalls, fines, and other penalties.
My assessment is that the new GMPs are a mixed bag of both surprises and expectations. They appear to be somewhat less stringent than some people in the industry predicted. At the same time, the FDA is adamant that specific goals be met through their implementation and enforcement. One of these goals is that whatever raw-material/component (and the amount of it) that is claimed on the label to be in the product is actually there. Companies will be required through testing to confirm on the Certificate of Analysis that the raw material is what it purports to be. And companies will be required to keep extremely good, clear and concise records as to the raw-material sourcing, manufacture and distribution of each product lot sold and distributed. Within these three areas, the FDA lays out specific compliance guidelines and requirements.
The agency appears to recognize that some companies might attempt to label their products as 'GMP Compliant' or 'FDA Approved.' My interpretation is that the FDA currently has no plans or methods to approve or certify a product, process, facility or company. Anyone claiming or advertising that its products, facility or processes are 'FDA Approved' is misleading its customers. In addition, expect to see a wide range of new symbols, logos and general claims that products, companies, facilities and/or processes are GMP compliant or approved. These also might be misleading.
There are organizations that can audit and certify a company for compliance to GMPs, and these companies have their own specific, registered logos. However, the public might now be exposed to all manner of claims that a company or product is Approved' or 'Certified' through GMP compliance. This means that marketers who might purchase finished products from a contract manufacturer, as well as consumers in general, will need to be cautious and careful not to be misled. It will be important for a marketer who purchases products from a contract manufacturer to be familiar with the new GMPs, to understand what organization certified the manufacturer and what that certification required.
What do the new GMPs say?
They establish what each manufacturer and marketer is required to do in order to ensure that its dietary supplements products are consistently produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled. They are designed to ensure that dietary supplements will be consistently manufactured according to their specifications, and are subject to manufacturing controls that prevent the products from being adulterated.
Raw materials and testing
Anybody marketing a dietary supplement will be required to ensure that the claimed amounts of each raw material are present in the product. This increases the responsibility on whomever is marketing the product to assure that the manufacturing and process of the product ensures the proper quantities of each raw-material component claimed on the label.
The FDA recognizes that it is far too difficult for the agency itself to try to track and audit each raw-material/component supplier, especially foreign suppliers. Therefore, manufacturers will be required to carry out complete testing of raw materials or components for identity, purity and potency in cases where there is a claim of specific potency. This will be critically important in the case of raw materials sourced from emerging countries or from companies without a proven history of supplying quality materials. The FDA wants a record of raw materials, components and ingredients sourced from emerging countries where GMPs and quality assurance may be less rigorous than those in the United States, as well as a process to ensure the identity and quality of those materials. The manufacturer will then be required to show that the proper amounts of each tested raw material were used in the processing and manufacturing of the finished product.
The new GMPs require relatively stringent documentation and record keeping of all processes involved in the production of a dietary supplement — from incoming controls to labeling operations. This will include product development, raw-material testing, manufacturing batch records, lot-number traceability and documentation of any reported adverse reactions caused by using the products. Manufacturers and/or marketers will be required to keep very detailed records covering all aspects of raw-material sourcing, testing, manufacturing, packaging, labeling and distribution of dietary supplements. The GMPs establish record-retention requirements so records will be available in case of an FDA inquiry or audit.
Standard Operating Procedures
The GMPs restate the FDA's requirements that manufacturers and distributors have good, clear, concise and accurate Standard Operating Procedures (SOPs). These should clearly describe how each process within a facility is to be carried out. They should be accessible to all individuals within each processing area. Operators and other area personnel should be completely familiar with the SOPs written and published for that particular area. Manufacturers' quality programs should be designed to ensure the company's compliance with these procedures.
During the coming months, I will take the opportunity in this column to examine the 'hot' items for which manufacturers and marketers need to be aware. In the meantime, there will certainly be several excellent industry organizations staging informational seminars, webinars and teleconferences. I suggest that essential individuals (including senior management, regulatory, QA, purchasing and production personnel) from each company plan to attend one of these informational opportunities.
Brian Frisby has worked for more than 20 years with major dietary supplements companies in positions that include director of quality assurance and regulatory compliance. He currently is manager of business development for the Americas for Capsugel, and a certified quality auditor.