Let’s face it: Compliance is complicated, and it’s probably one of the least appealing items on your plate. Still, requirements are becoming more and more stringent — and with good reason. High-regulation sectors like the food and dietary supplement industries are quickly growing, and customers have the right to know that these foods and products are safe.
So what does it mean to be FDA-compliant?
With the Food Safety Modernization Act, signed into law in 2011, the regulatory focus shifted from a reactive stance to a proactive one. The Preventive Controls Qualified Individual rule was a later addition to the FSMA, requiring companies to enact a food safety plan prepared by a PCQI. In order to achieve PCQI status, individuals must complete a training course.
The Foreign Supplier Verification Programs is another recent regulatory addition that went into effect in 2017. This ruling requires companies importing food for both human and animal consumption to verify that foreign suppliers are producing it in a way that complies with safety standards in the United States. In addition to keeping harmful ingredients out of food, FDA quality risk management regulations ensure that ingredients are properly labeled to lower the risk of allergic reactions in consumers.
With so many regulations to follow, achieving FDA compliance isn’t easy — but it doesn’t have to be as complicated as it seems.
Coping With Compliance Challenges
In the food industry, the FDA is responsible for dictating what ingredients are safe to put in food. You’ve probably noticed the cannabidiol — or CBD — craze sweeping the country, but is CBD FDA-approved? You might not know that companies are putting CBD in their food and beverages illegally, according to the Federal Food, Drug, and Cosmetic Act of 1938.
The FDA is set to hold a public hearing in May about products derived from hemp plants, but specific regulations won’t follow for some time. Until then, some states continue to allow restaurants and cafes to incorporate CBD in their menu items, while the practice is prohibited in states such as California and New York.
Dietary supplements are another example of an industry governed in large part by FDA regulations. A staggering 170 million Americans consume dietary supplements, contributing to what’s become a $40 billion industry. While most products meet FDA quality risk measurement standards, certain companies ignore regulations and make money selling dangerous products that put their customers at risk.
In order to alert consumers about the offending organizations, the FDA created a comprehensive Dietary Supplement Ingredient Advisory List. The list should help keep unethical companies out of the industry, which has grown from 4,000 products to more than 50,000 in the last 25 years.
Quick, Easy Quality Management
FDA documents rarely explain exactly how to achieve compliance. Instead, they list off certain mandatory requirements, and it’s up to you to find an FDA quality management system that checks the right boxes. If you’re unsure where to start for FDA QMS guidance, you’re not alone. That’s why Intellect has taken industry best practices and expertise and turned it into functional solutions that meet regulations and allow additional customization options if necessary.
Intellect’s eQMS software is meticulously designed to meet regulations because it adopts a process-based approach. Each process is built to establish five dimensions of quality: conformance, feature, performance, reliability, and responsiveness. Each process defines the policies, authorities, and responsibilities that the company is required to establish, and as a result, the process is comprehensive evidence to customers, suppliers, and employees that a company is committed to meeting requirements.
Whether your governing body is the FDA or the ISO, our solutions meet compliance and come with a complete workflow diagram, helping you turn a compliance chore into a competitive advantage. When you know exactly how to use your quality management system, it becomes much easier to not only demonstrate compliance to an auditor, but also to actually achieve it for your organization and your customers.
FDA QMS requirements aren’t going away anytime soon, but you can alleviate some of the challenge and make following these requirements a more straightforward process. With the right quality management system in place, you can ensure you’re following all the necessary laws without causing companywide compliance headaches.
