For nutraceutical companies, recent headlines promising an FDA crackdown on homeopathic products were probably a bit unsettling. A new draft guidance1 proposes that the FDA take a closer look at certain homeopathic products, such as those that are marketed to vulnerable groups or for serious illnesses. While the FDA technically has always had jurisdiction over homeopathy, anything labeled homeopathic can be manufactured and distributed without FDA approval. In effect, the FDA has given homeopathy a free pass. So why the sudden interest?
The homeopathy market has grown dramatically over the past decade into a $3 billion industry. With that growth has come problems with dangerous ingredients, improper manufacturing practices, and exaggerated claims. Most homeopathic products don’t pose any risk to consumers, but those that do can cause serious health problems and occasionally have led to death. To protect consumers, the FDA has identified six risk-based categories that it will focus on. Keeping your company out of these six categories will protect your consumers from potential harm and protect you from potential investigation.
Any one of these categories can be addressed individually, but they can all be addressed with an electronic enterprise quality management system (EQMS). The right EQMS used correctly, should keep a company off of the FDA’s radar. The six risk-based categories, and how the right system can avoid them, are listed below.
1) Products with reported safety concerns
Listening to your customers is always a good idea—especially when they’re reporting adverse events. In 2016, there were over 400 adverse events associated with homeopathic teething products, which led to the FDA issuing an announcement about the serious risks associated with these products. By using an EQMS, you can track customer complaints, including adverse events. When these problems are detected early, you can initiate a corrective and preventive action (CAPA) and fix the problem before it escalates.
To get the most for your money, look for an EQMS which allows you to not only track customer complaints, but also run reports by type of complaint and product. Find a solution that has versatile reporting capabilities so you can detect trends in the complaints received. The best EQMS will help you automate and manage the entire CAPA process.
2) Products that contain or claim to contain ingredients associated with potentially significant safety concerns
Sometimes the problems with homeopathic ingredients arise when what actually goes into the product doesn’t match what’s in the paperwork and on the label. If the ingredients are adulterated or are present in quantities that are larger than reported, problems can arise. This might happen if there are problems with a supplier or if your bill of materials (BOM) is incorrectly managed.
An EQMS can help you manage your suppliers and ensure that the ingredients you purchase from them are what you need in terms of quality and potency. Considering how many ingredients can be in one homeopathic product and the sheer number of products that most companies manufacture, keeping track of all this without an EQMS is an enormous undertaking. The right system will allow you to audit your suppliers, keep track of any problems, and monitor the quality of the ingredients you receive. When you detect supplier problems early, you can take corrective action before the FDA gets involved.
3) Products for routes of administration other than oral and topical
Let’s say you hire a new product developer who wants to formulate a homeopathic nose spray to help consumers with season allergies. Sounds like a harmless idea, right? Unfortunately, this category indicates that the FDA might disagree. This and other categories on this list need to be communicated to new hires, which requires a good training program.
The right EQMS will offer a training system that allows you to not only provide the correct information to your hires, but will allow you to ensure that they actually read and remember it. You can use these systems to monitor how long the document is open to make sure trainees take enough time to read it and you can write exams to make sure they retain the most important information. A good training program will help new hires avoid mistakes that can get you into hot water with the FDA.
4) Products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions and 5) Products for vulnerable populations
These two categories are grouped together because they both involve vague terms that haven’t been defined by the FDA. The terms “serious,” “life-threatening,” and “vulnerable populations” might mean something different to a nutraceutical company than they do to the FDA. More specifics on these terms will only be revealed as the FDA investigates individual products. As investigations take place and new information is received, it will need to be incorporated into your company’s standard operating procedures (SOPs). The most efficient way to do this is to have one centralized place to store the information which can be available to everyone who needs it. This will need to be a living document that can be updated, tracked, and will comply with FDA regulation 21 CFR Part 11.
Compliance with 21 CFR Part 11 will allow you to use electronic signatures to approve the new SOP and will make it easy to track what has been changed each time a new person edits or signs off on it. Look for an EQMS that is 21 CFR Part 11 compliant and that has routing, follow-up, and approval features to make sure the new SOP is being followed. As the FDA comes out with more information, you can make sure that your organization responds to and incorporates it.
6) Products that do not meet standards of quality, strength, or purity as required under the law
This category should come as no surprise to anyone. Nutraceutical companies have always had to follow current good manufacturing practices (CGMPs), so they should be fully prepared for this part of the new guidance. CGMPs ensure quality, strength, and purity, and when followed provide a framework that will detect any problems before the FDA gets involved. However, just following CGMPs isn’t enough—you have to prove you’re following them. An EQMS will provide the tools to prepare for an investigation, making all documentation easily accessible and ensuring that all your i’s are dotted and your t’s are crossed.
The FDA itself said that most homeopathic products aren’t high-risk by this definition, but taking proactive steps now makes it far less likely for a company to come under investigation in the future. There is no way of knowing if the FDA will add to this guidance or how exactly they’ll define some of the above terms. The safest move is to implement an EQMS system now that has the above-mentioned traits, allowing your company to avoid these pitfalls and remain free from FDA investigation.
1. “Drug Products Labeled as Homeopathic: Guidance for FDA Staff and Industry.” https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformationrmation/Guidances/UCM589373.pdf
Sarah Beale is a content marketing specialist at MasterControl in Salt Lake City, Utah. She has a bachelor’s degree in English from Brigham Young University and a master’s degree in business administration from DeVry University.