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21 U.S. Code 342 (g) — The Unknown Law that Can Put Supplement Brands Out of Business
The ABH 859 recall is a wake-up call to the supplement industry and what you can learn from it might just save your business.
I’m going to say something controversial that may upset many supplement industry insiders, but before you judge what I have to say, hear me out. I strongly believe that the ABH 859 recall is good for the industry and will produce profound positive changes in the future, the benefits of which will far outweigh the negatives. Certainly, a recall of this magnitude is bad for the industry and will weaken consumer confidence for years to come. But this particular recall is far different from past recalls because it brings to light a little-known law that will soon be sending shock waves through boardrooms across the country. Imagine if you spent years building up your brand only to be wiped out by a law you didn’t know existed.
Before I go into the law itself, let’s look at ABH 859, because it will help you understand the application and severity of the law. In my 25 plus years in this industry, I have never seen a dietary supplement recall with the depth and scope of ABH 859, so the question needs to be asked: How can the FDA recall thousands of products from all 859 companies that ABH manufactured for, without testing any of them to prove they were adulterated? On its face, this seems to be unreasonable and possibly unlawful and dozens of brand owners have questioned me on this. So, if the FDA didn’t test the products, how did they know they were adulterated, and how could they force a recall of them? Well, that’s where this little-known law comes in to play. Knowing the severity of the implications of this law, it surprised me how so few brand owners knew about it.
To understand the legal definition of the term “adulterated” as it applies to dietary supplements, we need to go beyond CFR 111 regulations and look at the United States Code, or the laws themselves. Federal law is crystal clear on the definition of “adulterated.” If a manufacturing, packaging or holding facility is not compliant with cGMP regulations, then all dietary supplements manufactured in that facility are deemed to be “adulterated.” Think about that: according to the law, even if the dietary supplement meets label claim, it is still deemed to be adulterated if the manufacturer was not compliant with cGMP Title 21 CFR Part 111 regulations. That’s exactly what happened to all 859 brands whose products were manufactured by ADH — the FDA did not need to test the products to deem them adulterated because they ruled that ABH was not compliant with cGMP regulations.
Here is the law as stated in 21 U.S. Code 342 (g): “A food shall be deemed to be adulterated… If it is a dietary supplement and it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations….” The law could not be clearer; it’s written in simple language with no caveats. It should scare the hell out of brand owners, because you now understand how the FDA can retroactively deem your products to be adulterated and force a recall many years after you sold them, as in the case of ABH where they went back seven years.
Imagine if your brand had engaged ABH to exclusively manufacture your supplements for the past few years. You put all your eggs in one basket, and that basket just crashed to the ground. You now need to destroy your entire on-hand inventory, recall all inventory from your wholesalers and distributors, and then issue a public recall to consumers. No company could withstand that hit and survive. Could you petition the FDA to be removed from the recall list if you could prove your products met label claim and were free of contamination? Maybe, but would the FDA agree to take on that liability? I doubt it, because testing for label claim, microbial contamination, and heavy metals, does not prove the product is safe and efficacious. Allergens, banned ingredients and gluten introduced by cross-contamination could be present along with a host of other variables that would not be picked up in standard testing. The only way to ensure the safety and efficacy of a dietary supplement is to establish and follow written procedures that consider these factors in advance and prevent them — hence cGMP regulations and the U.S.C. 342 law that gives it not just a bark, but one hell of a bite.
The risk to brand owners is staggering. Over half of the contract manufacturing organizations (CMO) in the United States have not yet been audited for cGMP compliance by the FDA. Imagine if you are, at this moment, dealing with another ABH type CMO and don’t realize it. Now that you understand U.S.C. 342, consider the consequences to you when the FDA comes knocking at your CMO’s door, and ultimately yours. I’m sure you get the picture, so what should you be doing to eliminate the risk and protect your brand?
First, understand that I am not attacking CMOs. They are not fundamentally bad. On the contrary, without CMOs the dietary supplement industry would not exist as it does today, or it might not even exist at all. The regulatory landscape is far too intense and complicated for an entrepreneur starting a new brand to even consider manufacturing on their own. cGMP is a buzzword everyone is talking about, yet most brands are just becoming acquainted with its complexities. There are so many laws and regulations beyond CFR Part 111 that come into play, such as DSHEA, the all-important act that defines dietary supplements and ingredients; CFR Part 101 for labeling; and the United States Code of laws (U.S.C.). There is the Federal Food, Drug and Cosmetic Act (FFD&C) and Food Safety Modernization Act (FSMA). If you have functional foods, then CFR 110 and 100 come in to play. Your brain is probably spinning thinking about this, but don’t worry, a good CMO, with a strong regulatory compliance department, has already locked the manufacturing portion of this down.
Within the dietary supplement industry, there are plenty of great CMOs that understand and comply with the regulations and laws, but all too often brands rely on price as the sole factor in choosing one of them. As a brand owner, it’s your responsibility to ensure that your supplements are in compliance with all regulations, whether you manufacture yourself or farm hat job out. You must weed through CMOs until you find the right one — your existence depends on it. You must qualify your CMO by doing proper due diligence research, a site inspection and a cGMP audit prior to engaging their services. You must test your products to ensure they meet label claim and follow through with periodic audits of the CMO to ensure it maintains cGMP compliance. Any decent CMO will not be insulted by any of this because they understand the necessity for it.
Here is a sample of some of the due diligence that should be done on your CMO. This is by far not a complete list, but it gives you an idea of what a CMO audit looks like. If you don’t have sufficient cGMP experience, hire a consultant that specializes in cGMP audits. Join them for the site inspection and audit, you’ll be amazed at how much you will learn from the experience.
To qualify a CMO you should do proper due diligence research. Google them! In the case of ABH, you might have found their prior warning letters, 483 observances, salmonella recalls, accusations of producing fake products and other red flags. Verify any of their certifications. Ask for references and call them. Do a site inspection and cGMP audit of their facility, as explained below.
Once you have qualified and engaged a CFO, draft a written agreement for each product that lists all specifications, including active ingredients with dosages, inactive ingredients, excipients and patented or trademarked ingredients you require. Specify limits and testing methods for active ingredients. Specify all packaging, including bottle, cap, label, seals, scoops, descant, cotton and so forth, including color, size, material, and brand if required. Include label specifications plus any other specifications you require. Review and sign off on the master manufacturing record (MMR) prior to approving the initial production run of a new product. Require written notice of any change to an MMR and your written approval of those changes. Require COA and supporting test results for each lot of finished product, including assay, heavy metals, and microbial testing. Require batch production records (BPRs) for each lot, or at a minimum require copies of the first three lots for each new product, and if any changes are made to the MMR start the process over. Test all finished products using your own lab. Don’t test a sample sent by the CMO, but choose a random container from the finished product shipped to your warehouse. Make sure they meet your agreed specifications and match the vendor’s COA.
Do annual cGMP audits of the CMO facility, including cGMP site inspection and a review of SOPs and training logs. Review your MMRs and BPRs along with corresponding supporting documents for a random and representative selection of lots. Review raw ingredient identity testing and purity, strength and composition testing. Review finished product testing. Review the CMO’s prior FDA cGMP audit documents, including the establishment inspection report (EIR), 483s and warning letters, along with all corrective actions taken.
This article gives you food for thought regarding your responsibilities as the brand owner for regulatory compliance and protecting your brand. It’s not inclusive of everything you should be doing. My experience comes from 20 years of being a manufacturer. I’ve been through six full GMP audits, the most recent of which lasted three weeks. They are not easy, and they are not fun. I am not an attorney or consultant that specializes in compliance, but you should hire a legal team and regulatory consultant as needed to ensure that you are in compliance with all aspects of the laws and regulations for dietary supplements.
Understand that the FDA can audit your CMO, you, or both at any time. As the brand owner, you are ultimately responsible for the dietary supplements you introduce into interstate commerce. The liability ultimately rests with you, not the CMO. The FDA has shown its position to be that cGMP compliance flows through all organizations associated with the product, including the manufacturer, packager, labeler, holder and brand owner. The FDA has taken the position that the brand owner, although not specified in CFR 111, is jointly responsible with the CMO. A management agreement between the parties that transfers regulatory responsibility to a specific party, does not relieve any party from their obligation to comply with the regulations. As the brand owner, you are in it until the end. If you haven’t audited your CMO, your products could currently be adulterated and at risk of suffering the fate of the ABH 859.
The ABH 859 recall is a wake-up call to the supplement industry and what you can learn from it might just save your business.
I’m going to say something controversial that may upset many supplement industry insiders, but before you judge what I have to say, hear me out. I strongly believe that the ABH 859 recall is good for the industry and will produce profound positive changes in the future, the benefits of which will far outweigh the negatives. Certainly, a recall of this magnitude is bad for the industry and will weaken consumer confidence for years to come. But this particular recall is far different from past recalls because it brings to light a little-known law that will soon be sending shock waves through boardrooms across the country. Imagine if you spent years building up your brand only to be wiped out by a law you didn’t know existed.
Before I go into the law itself, let’s look at ABH 859, because it will help you understand the application and severity of the law. In my 25 plus years in this industry, I have never seen a dietary supplement recall with the depth and scope of ABH 859, so the question needs to be asked: How can the FDA recall thousands of products from all 859 companies that ABH manufactured for, without testing any of them to prove they were adulterated? On its face, this seems to be unreasonable and possibly unlawful and dozens of brand owners have questioned me on this. So, if the FDA didn’t test the products, how did they know they were adulterated, and how could they force a recall of them? Well, that’s where this little-known law comes in to play. Knowing the severity of the implications of this law, it surprised me how so few brand owners knew about it.
To understand the legal definition of the term “adulterated” as it applies to dietary supplements, we need to go beyond CFR 111 regulations and look at the United States Code, or the laws themselves. Federal law is crystal clear on the definition of “adulterated.” If a manufacturing, packaging or holding facility is not compliant with cGMP regulations, then all dietary supplements manufactured in that facility are deemed to be “adulterated.” Think about that: according to the law, even if the dietary supplement meets label claim, it is still deemed to be adulterated if the manufacturer was not compliant with cGMP Title 21 CFR Part 111 regulations. That’s exactly what happened to all 859 brands whose products were manufactured by ADH — the FDA did not need to test the products to deem them adulterated because they ruled that ABH was not compliant with cGMP regulations.
Here is the law as stated in 21 U.S. Code 342 (g): “A food shall be deemed to be adulterated… If it is a dietary supplement and it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations….” The law could not be clearer; it’s written in simple language with no caveats. It should scare the hell out of brand owners, because you now understand how the FDA can retroactively deem your products to be adulterated and force a recall many years after you sold them, as in the case of ABH where they went back seven years.
Imagine if your brand had engaged ABH to exclusively manufacture your supplements for the past few years. You put all your eggs in one basket, and that basket just crashed to the ground. You now need to destroy your entire on-hand inventory, recall all inventory from your wholesalers and distributors, and then issue a public recall to consumers. No company could withstand that hit and survive. Could you petition the FDA to be removed from the recall list if you could prove your products met label claim and were free of contamination? Maybe, but would the FDA agree to take on that liability? I doubt it, because testing for label claim, microbial contamination, and heavy metals, does not prove the product is safe and efficacious. Allergens, banned ingredients and gluten introduced by cross-contamination could be present along with a host of other variables that would not be picked up in standard testing. The only way to ensure the safety and efficacy of a dietary supplement is to establish and follow written procedures that consider these factors in advance and prevent them — hence cGMP regulations and the U.S.C. 342 law that gives it not just a bark, but one hell of a bite.
The risk to brand owners is staggering. Over half of the contract manufacturing organizations (CMO) in the United States have not yet been audited for cGMP compliance by the FDA. Imagine if you are, at this moment, dealing with another ABH type CMO and don’t realize it. Now that you understand U.S.C. 342, consider the consequences to you when the FDA comes knocking at your CMO’s door, and ultimately yours. I’m sure you get the picture, so what should you be doing to eliminate the risk and protect your brand?
First, understand that I am not attacking CMOs. They are not fundamentally bad. On the contrary, without CMOs the dietary supplement industry would not exist as it does today, or it might not even exist at all. The regulatory landscape is far too intense and complicated for an entrepreneur starting a new brand to even consider manufacturing on their own. cGMP is a buzzword everyone is talking about, yet most brands are just becoming acquainted with its complexities. There are so many laws and regulations beyond CFR Part 111 that come into play, such as DSHEA, the all-important act that defines dietary supplements and ingredients; CFR Part 101 for labeling; and the United States Code of laws (U.S.C.). There is the Federal Food, Drug and Cosmetic Act (FFD&C) and Food Safety Modernization Act (FSMA). If you have functional foods, then CFR 110 and 100 come in to play. Your brain is probably spinning thinking about this, but don’t worry, a good CMO, with a strong regulatory compliance department, has already locked the manufacturing portion of this down.
Within the dietary supplement industry, there are plenty of great CMOs that understand and comply with the regulations and laws, but all too often brands rely on price as the sole factor in choosing one of them. As a brand owner, it’s your responsibility to ensure that your supplements are in compliance with all regulations, whether you manufacture yourself or farm hat job out. You must weed through CMOs until you find the right one — your existence depends on it. You must qualify your CMO by doing proper due diligence research, a site inspection and a cGMP audit prior to engaging their services. You must test your products to ensure they meet label claim and follow through with periodic audits of the CMO to ensure it maintains cGMP compliance. Any decent CMO will not be insulted by any of this because they understand the necessity for it.
Here is a sample of some of the due diligence that should be done on your CMO. This is by far not a complete list, but it gives you an idea of what a CMO audit looks like. If you don’t have sufficient cGMP experience, hire a consultant that specializes in cGMP audits. Join them for the site inspection and audit, you’ll be amazed at how much you will learn from the experience.
To qualify a CMO you should do proper due diligence research. Google them! In the case of ABH, you might have found their prior warning letters, 483 observances, salmonella recalls, accusations of producing fake products and other red flags. Verify any of their certifications. Ask for references and call them. Do a site inspection and cGMP audit of their facility, as explained below.
Once you have qualified and engaged a CFO, draft a written agreement for each product that lists all specifications, including active ingredients with dosages, inactive ingredients, excipients and patented or trademarked ingredients you require. Specify limits and testing methods for active ingredients. Specify all packaging, including bottle, cap, label, seals, scoops, descant, cotton and so forth, including color, size, material, and brand if required. Include label specifications plus any other specifications you require. Review and sign off on the master manufacturing record (MMR) prior to approving the initial production run of a new product. Require written notice of any change to an MMR and your written approval of those changes. Require COA and supporting test results for each lot of finished product, including assay, heavy metals, and microbial testing. Require batch production records (BPRs) for each lot, or at a minimum require copies of the first three lots for each new product, and if any changes are made to the MMR start the process over. Test all finished products using your own lab. Don’t test a sample sent by the CMO, but choose a random container from the finished product shipped to your warehouse. Make sure they meet your agreed specifications and match the vendor’s COA.
Do annual cGMP audits of the CMO facility, including cGMP site inspection and a review of SOPs and training logs. Review your MMRs and BPRs along with corresponding supporting documents for a random and representative selection of lots. Review raw ingredient identity testing and purity, strength and composition testing. Review finished product testing. Review the CMO’s prior FDA cGMP audit documents, including the establishment inspection report (EIR), 483s and warning letters, along with all corrective actions taken.
This article gives you food for thought regarding your responsibilities as the brand owner for regulatory compliance and protecting your brand. It’s not inclusive of everything you should be doing. My experience comes from 20 years of being a manufacturer. I’ve been through six full GMP audits, the most recent of which lasted three weeks. They are not easy, and they are not fun. I am not an attorney or consultant that specializes in compliance, but you should hire a legal team and regulatory consultant as needed to ensure that you are in compliance with all aspects of the laws and regulations for dietary supplements.
Understand that the FDA can audit your CMO, you, or both at any time. As the brand owner, you are ultimately responsible for the dietary supplements you introduce into interstate commerce. The liability ultimately rests with you, not the CMO. The FDA has shown its position to be that cGMP compliance flows through all organizations associated with the product, including the manufacturer, packager, labeler, holder and brand owner. The FDA has taken the position that the brand owner, although not specified in CFR 111, is jointly responsible with the CMO. A management agreement between the parties that transfers regulatory responsibility to a specific party, does not relieve any party from their obligation to comply with the regulations. As the brand owner, you are in it until the end. If you haven’t audited your CMO, your products could currently be adulterated and at risk of suffering the fate of the ABH 859.
