The recent recall announcement for the ABH859 has sent shock waves through the dietary supplement industry. The chatter is unbelievable, with back room conversations going on in every corner of the industry: Are we compliant? Do we have to audit our CMO? Do we have to test our products? I was up until 4:30 last evening answering compliance questions and had to grab a local hotel to get 2 hours of sleep before it started all over again this morning. At one point I was involved in 4 conversations regarding ingredient testing, so I decided to write this up for those in the industry who are interested.
Raw ingredients are the foundation of any great dietary supplement, they are the bones upon which everything else is built on. If your ingredients are sub par it makes no difference how impressive your formula is, how compliant your manufacturing is or how cool your packaging is; it’s all worthless.
Manufacturing dietary supplements is NOT the wild west as many in the media might have you believe. The FDA has specific regulations for the manufacturing, packaging, holding and labeling of dietary supplements. These regulations are part of the Code of Federal Regulations known as 21 CFR Part 111. The purpose of these regulations are to protect the consumer by insuring that all finished dietary supplements meet label claim and are free of contamination that could adulterate the product. The term CGMP that is often thrown around is the acronym for this set of regulations (Current Good Manufacturing Practices).
Section 111.70 and 111.75 of the code requires that a manufacturer must test each and every lot of dietary component (raw ingredient) to insure that it meets predetermined specifications for purity, strength, composition and identity before it can be used in a dietary supplement. Ingredients must be quarantined in a separate location within the warehouse until the Quality Control (QC) unit approves all pre-determined protocols and specifications for that ingredient. Only after final approval by the QC unit can an ingredient be released into production. There are numerous other protocols and specifications for ingredient release such as document approval (COA, allergen and non-gmo statements, etc.) but for the purpose of this discussion I am focusing on the testing portion only.
To better understand testing requirements I’ll break them into two groups: Group 1 is Identity and Group 2 encompasses Purity, Strength and composition.
Identity is basic testing that simply proves that the ingredient is exactly what it should be. If the ingredient was broccoli, organoleptic testing as simple as comparing it to a photograph of broccoli is fine. However, it’s not so simple for dietary ingredients that all look alike. For example, creatine and glutamine are both white powders that look similar, so more exacting tests need to be done. At NutraBio we use FTNIR to identify many ingredients and other methods for botanicals.
Identity testing cannot be done periodically; it must be done for each and every lot. Testing must be representative of the entire lot so testing one container is not sufficient if there are multiple containers in the lot. The code does not specify how to do this so the FDA has unofficially accepted a best industry practice for how many containers of a specific lot must be tested. The calculation is as follows: (the square root of total containers plus 1). So if you have 16 containers in that lot (SR of 16=4 +1=5). So you must test samples from 5 random containers and samples must be pulled from random positions within each container.
Group 2 has different requirements as per the code. Testing ingredients for purity, strength and composition can be accomplished by either of two methods. You can test each lot to insure it meets predetermined specifications or the Code allows you to qualify the vendor by establishing reliability of their COA.
The code does not specify exactly how to accomplish vendor qualification so the FDA once again unofficially accepts a best industry practice, which is: For each component you must qualify the vendor by testing the first 3 consecutive lots of the ingredient against its corresponding COA. Testing must be representative of the entire COA so just testing assay in not sufficient. After you have validated the reliability of 3 COAs from 3 consecutive lots received into your facility, you have qualified that component for a specific period. During the qualified period, identity testing is still required for every lot, but purity, strength and composition can be skipped.
The qualification period that most companies have adopted and the FDA seems to go along with is 1 year, after which you must reestablish qualification of that vendor for that ingredient. Re-qualification of a vendor requires validation of only 1 LOT/COA. The term Vendor Qualification is misleading because you haven’t qualified the vendor, you have only qualified one ingredient supplied by that vendor. The process must be repeated for every different ingredient supplied by that vendor. In addition, if you purchase that same ingredient from a different manufacturer you have to qualify that vendor as well. So lets say you purchase creatine from 3 different manufacturers, you must establish vendor qualification for all 3.
What I’ve gone over here is the bare minimum required to be in compliance with this small section of the Code. Do I recommend the bare minimum? Absolutely NOT! At NutraBio I test every lot of raw ingredient and every lot of finished product. In the end, you and you alone, as the brand owner, are liable for your product. Even if the FDA found no observances in a dozen audits and the NSF and the UL granted you those pretty GMP certificates… if your product is adulterated, misbranded and doesn’t meet label claim, you will pay the consequence. As I stated from the start, it all in the bones — the raw ingredients make the product.
This explanation was only a small a part of section 170 and 175 of 21 CFR Part 111, there are more than 80 additional sections to the code and there are additional codes and regulations such as DSHEA, FSMA and the FD&C Act. So there you have it, there is no wild west in the dietary supplement industry as so many politicians and media pundits scream about. There is order and structure. Of course there will always be the outlaws. Those pitiful souls that are motivated by greed and care nothing for the consumer or the future of the industry.
I hate to say this, but in some way, the ABH859 recall might be a good thing. It just might be the kick in the ass that was needed to push the industry to the next chapter of its existence; where quality, efficacy, transparency and honesty play a more dominant role and the customers safety and benefit becomes our guiding light.