We meet dietary supplement companies regularly who are shocked when the FDA shows up to inspect their company for cGMP compliance when the company doesn’t produce any product. Is the FDA off their rocker? In short – no. All companies who market dietary supplements under their own brand (IE, your company name is in the “Distributed By” or “Manufactured For” line) are required to have some semblance of a cGMP and Quality program in place, IN ADDITION TO the fancy program at the contract manufacturer’s facility.
Contract manufacturers are commonly used by companies with marketing prowess but who either don’t yet have capital for their own manufacturing, or who simply realize that isn’t their cup of tea and they’d rather let the experts deal with the production. Many companies think the manufacturer will handle all the quality and cGMP red tape and all the company needs to do is sell. Unfortunately, that isn’t how the regulations work. Companies who sell dietary supplements are required to ensure the product is produced according to all regulations, including manufacturing regulations (known as cGMP or current Good Manufacturing Practices). This means all companies must have someone in charge of quality control. This person (or people) must audit your contract manufacturers (this doesn’t mean just walk around the facility, but they must actually look at procedures, batch records, etc. and make a record of their visits), must review and approve batch production records, must review and approve labels, must release product for distribution, etc. The FDA’s approach is that a company may contract the production, but must take ownership of the quality control and ultimate cGMP compliance. So where do you begin?
1 – Visit your contract manufacturer
Understand basically what they are doing. Ask whether they have any third party certifications and if so, ask for a copy of the most recent audit report from that certifying body. If you have the resources, hire an expert to conduct an audit of the contract manufacturer on your behalf. Though certifications are good, ultimately certification bodies only make money if people are certified, so I always suggest having an expert you trust double check the compliance of your facility (in reality, seasoned quality teams know how to lead auditors into areas that look good and keep them out of areas that look bad, so having another seasoned expert conduct an audit can eliminate potential layers of wool hiding problem areas).
2 – Review batch records
Start asking to review batch production records for each batch of product produced on your behalf. Manufacturers will try to tell you they can’t share them or that they are proprietary. If that is the story you get, I highly suggest you find a new manufacturer (I can give some referrals if you need some). You are responsible for your product and if you can’t see how it was made and verify the manufacturer made it according to your purchase order and your label, you are the one bearing the risk because it will be your brand that is the subject of a public trial. Some manufacturers may say you can only review them on site, which, if they are close, isn’t a big deal, but if they are remote – start looking for a new manufacturer.
3 – Make sure you have a product specification
This should include a reference to the correct label, the identity and amount of active ingredients (the ingredients listed in your supplement facts panel), an ingredient list, and a physical description, as the most basic aspects. I highly suggest including some chemical and microbiological portions as well for safety and quality purposes.
There are other requirements your company will need to meet, but if you at least start with the 3 steps above, you are going to be on your way to becoming prepared should the FDA show up at your doorstep (it will happen, it is just a matter of time). So what do you risk if you don’t do this? Well, if you eventually get a warning letter, the FDA may not shut you down, but private party litigators love to go after companies with warning letters. Your company will get a black eye and possibly a very hefty settlement bill with that black eye. It may cost you a bit now, but in the end, it will protect your brand from being drug through the mud in court and in public.
Do you need to have a cGMP program? Just ask yourself how important your brand and company is to you. If it isn’t important, then you may choose to roll the dice, but if you value your blood, sweat, tears, and hard earned money, I highly suggest you not play this game of roulette with the FDA because ultimately, you will lose.
If you need help or want to learn more, we are happy to help. Give us a call, send us a text, or email at [email protected].