Where do dietary supplement marketers stand within FSMA? First off, supplement makers are still subject to the rules of the Dietary Supplement Health and Education Act of 1994 (DSHEA), which primarily governs labeling. Both FSMA and DSHEA classify supplements as food. Also, since 2010, supplement makers are governed by GMP regulations according to CFR Part 111.
FSMA, however, gives FDA expanded authority in requiring recalls and suspending facility registrations. Already under FSMA, last November the agency mandated a recall of pre-workout supplement OxyElite Pro, which was allegedly associated with cases of liver damage. Currently under FSMA, makers of supplements must register their facilities with FDA. However, supplement makers were not immediately subject to the full regulations of FSMA, creating ambiguity and anxiety about when FSMA will levy its full regulations on supplements. Still, most in the industry expect that the full regulations will eventually apply to them as well.
In short, FSMA represents a major shift in the regulatory landscape. The fact that various, previous laws have identified dietary supplements as food, and the likelihood that supplements will eventually be covered by FSMA, indicate that manufacturers and processors of supplements should be rigorously informing themselves now on how FSMA will affect their businesses and should be preparing to comply.
For years, food processing and packaging companies have tended to think of the HACCP (Hazard Analysis and Critical Control Points) approach to food safety developed in the 1960s as the gold standard of food-safety assurance. But FDA’s 2013 Proposed Rule for Preventive Controls for Human Food, as required by FSMA, takes a broader approach to food safety. It does require preventive controls based on hazard analysis, but FSMA describes those controls as being “similar” to the HACCP system and requires controls that may be required at points other than the traditional Critical Control Points.
This broader approach to food safety reflects FDA’s revised position that, while the proposed preventive controls are science- and risk-based and require controls where necessary to prevent hazards to public health, they also need to be flexible to allow firms to develop preventive controls that fit their specific products and operations—as long as controls are adequate to significantly minimize or prevent all food-safety hazards.
Preventive controls are intended to ensure that hazards that are “reasonably likely to occur” will be significantly minimized or prevented. As a result, affected companies are advised to look beyond HACCP solutions when establishing food safety–assurance programs. They should establish teams dedicated to creating a complete program of hazard-prevention controls to ensure food safety and developing a plan for implementing it. This written plan will contain thorough, detailed documentation of identified potential hazards, operational food-safety preventive controls, and related maintenance operations.
The written documentation will detail the potential hazards identified, what preventive controls have been implemented to prevent contamination or factors otherwise affecting the safety of the food being processed and packaged, and how those controls will be verified, validated, and maintained.
How Inspection Systems Help
Once a safety regimen is established, systematic, machine-based inspection systems for products and packages provide the means to both detect and reject contaminated or otherwise non-compliant products or packaging, while maintaining accurate, complete records of those actions. This documentation is critical, because the first thing FDA is going to ask for during an inspection is written documentation.
Here are the basic food-safety inspection systems and what they offer:
- Checkweighing systems weigh packaged products to ensure that stated package weights are accurate and that packages are correctly filled. This is done on the fly at production-line speeds and does not slow production. Non-standard-weight packages are automatically rejected form the production line for re-work.
- Metal-detection systems inspect products to ensure that they are free from metal contamination that may have been included in raw materials or that may have been dislodged from processing equipment (especially screens) during production. These systems can detect even the finest sieve wire pieces. Contaminated products are automatically rejected from the line and are usually discarded. These systems can be positioned on a conveyor line or can inspect individual tablets as they are gravity-fed through the metal-detection system.
- X-Ray inspection systems inspect products for both metal and other types of contamination—glass, bone, stone, certain plastics, etc.—and remove contaminated products from the line. The newest systems use highly sensitive detectors, which means the X-ray generators can use less power, providing the same results in smaller, more-energy-efficient systems than systems past.
- Machine vision systems use cameras and special software to inspect products, packages, and labels for defects. The systems compare what they “see” with a reference database and reject what does not agree. Malformed or incomplete tablets, low or high fill levels of liquids or powders, cocked or insecure closures, incorrect labels or labels with wrinkles that cover vital ingredients, etc., can be detected.
All of these inspection systems are designed to be compact so they fit into existing lines, without extreme disruption, or to fit over existing production lines, requiring no breaking into the line. They may be used singly or in combination. There are also systems that combine multiple inspection types in one machine. The controls of all of these systems interact with each other and with your production-control systems so that line speeds and inspection speeds are coordinated, for example, and defective or contaminated products are identified for rejection farther down the line. Most systems are also available in a variety of capacities to match different production facility capabilities, and they can usually be customized to meet the specific needs of the end-user.
A few manufacturers of inspection equipment also produce data-collection systems that instantly collect inspection and rejection data, store it in a central location (that can also collect data from a company’s multiple facilities), and make it available on demand in the event of a system performance review or an FDA inspection.
This capability is invaluable. It offers insight into the performance of your production, often pinpointing bottlenecks and other problem areas, facilitating continuous improvement leading to increased efficiencies.
Sophisticated, high-speed, efficient inspection equipment can be deemed costly when viewed as a capital cost; however, these are well-built machines that perform tirelessly for years. Viewed in terms of their long-term assurance of quality, product safety, and protection against recalls and even liability lawsuits, they provide an immediate return on investment.
Robert Rogers, senior advisor for food safety and regulation at Mettler Toledo Product Inspection Group (Tampa, FL), serves as a subject matter expert to various regulatory and industry organizations such as the FDA, the Grocery Manufacturers Association (GMA), and the Packaging Machinery Manufacturers Institute (PMMI). He also writes articles and blogs about critical industry issues. Contact him directly at [email protected] or by phone at 813/342-9138. The Mettler Toledo Product Inspection Group is the world’s leading supplier of in-line checkweighers, machine vision systems, metal detectors, and x-ray inspection systems.