By Duffy MacKay, ND, Senior Vice President, Scientific & Regulatory Affairs, Council for Responsible Nutrition04.02.18
True or false: Companies ready to put a new product to market have clear direction on the status of ingredients.
This seems simple enough. Old dietary ingredients (ODIs) are dietary ingredients marketed in the United States before Oct. 15, 1994, when the Dietary Supplement Health and Education Act (DSHEA) was enacted. Juxtaposed with new dietary ingredients (NDIs), which require manufacturers to submit a pre-market notification to FDA at least 75 days before a dietary supplement is marketed, ODIs are not subject to this pre-market review. Super easy and clear, right?
Wrong. Under the current system, companies have limited resources and often no way of knowing if an ingredient is an ODI. A heavy burden on manufacturers, especially those new to the industry, the absence of an authoritative list of ingredients exempt from NDI notifications forces companies to dig up old evidence such as advertisements, marketing brochures, scientific literature, and internal documents in order to provide the necessary evidence required by FDA before a product hits store shelves.
Info on ‘Identity’
There are thousands of common vitamins, minerals, botanicals, and other ingredients that were indisputably on the market pre-DSHEA. However, a 1993 magazine ad marketing chamomile may not be enough to get the green light from regulators. FDA suggests it would need to receive information that describes the “identity” of the ingredient, such as the plant part, type of extract (water, alcohol, etc.), the ingredient source, or the manufacturing method.
But how many of us have 24-year-old documents at our disposal? Do you have a way to open the files on that eight-inch floppy you found buried in a box somewhere? Do you have immediate access to a microfilm reader? To assume companies would have maintained these types of records is unreasonable, which is why a publicly available, FDA-sanctioned database of ODIs would alleviate the uncertainty and burden of gathering proof for companies, allowing them to have clarity about dietary ingredients. So, what’s the holdup?
Back in 1994, after DSHEA passed, the leading industry trade associations and their members compiled lists of ingredients the new law had declared “grandfathered.” Unfortunately, in the 2011 NDI Draft Guidance, FDA stated that in the absence of supporting evidence, these lists were not enough to serve as an authoritative resource. This decision spurred a diverse set of opinions regarding the best path forward among stakeholders. Has too much time passed to be able to provide FDA with sufficient evidence to make a meaningful list? If a company does have access to the requested evidence, will they use it as an opportunity to make money instead of sharing it openly? Perhaps industry does not have an obligation to do anything and the burden of gathering documentation is instead FDA’s?
Creating Clarity
We’ve had a quarter of a century to think this over. Generally supportive of FDA’s willingness to develop a pre-DSHEA ingredient list, industry recognizes such a list would not only benefit supplement manufacturers, but FDA—and even consumers—as well, so long as it is appropriately crafted and tailored in collaboration with stakeholders.
FDA’s current efforts toward developing an ODI list is an opportunity to create clarity as to the regulatory status of a wide variety of dietary ingredients, but CRN calls for something more: a list that includes the entire universe of ingredients that do not require NDI notification. This family of ingredients includes:
Considering the stakeholder input it has received over the past two and a half decades, FDA is now tasked with conducting a close investigation of the resources available and evaluating the pros and cons of moving forward on this project. In the meantime, the current NDI draft guidance remains the agency’s most current thinking on the topic, and companies would be wise to follow those processes. If a company is unsure about whether an ingredient needs notification, CRN suggests consulting a trade association, a regulatory attorney, or FDA directly. If you ask, you may not like the answer, but at least there will be clarity.
Duffy MacKay, ND, is the senior vice president, scientific & regulatory affairs, Council for Responsible Nutrition (CRN), a leading trade association for the dietary supplement and functional food industry.
This seems simple enough. Old dietary ingredients (ODIs) are dietary ingredients marketed in the United States before Oct. 15, 1994, when the Dietary Supplement Health and Education Act (DSHEA) was enacted. Juxtaposed with new dietary ingredients (NDIs), which require manufacturers to submit a pre-market notification to FDA at least 75 days before a dietary supplement is marketed, ODIs are not subject to this pre-market review. Super easy and clear, right?
Wrong. Under the current system, companies have limited resources and often no way of knowing if an ingredient is an ODI. A heavy burden on manufacturers, especially those new to the industry, the absence of an authoritative list of ingredients exempt from NDI notifications forces companies to dig up old evidence such as advertisements, marketing brochures, scientific literature, and internal documents in order to provide the necessary evidence required by FDA before a product hits store shelves.
Info on ‘Identity’
There are thousands of common vitamins, minerals, botanicals, and other ingredients that were indisputably on the market pre-DSHEA. However, a 1993 magazine ad marketing chamomile may not be enough to get the green light from regulators. FDA suggests it would need to receive information that describes the “identity” of the ingredient, such as the plant part, type of extract (water, alcohol, etc.), the ingredient source, or the manufacturing method.
But how many of us have 24-year-old documents at our disposal? Do you have a way to open the files on that eight-inch floppy you found buried in a box somewhere? Do you have immediate access to a microfilm reader? To assume companies would have maintained these types of records is unreasonable, which is why a publicly available, FDA-sanctioned database of ODIs would alleviate the uncertainty and burden of gathering proof for companies, allowing them to have clarity about dietary ingredients. So, what’s the holdup?
Back in 1994, after DSHEA passed, the leading industry trade associations and their members compiled lists of ingredients the new law had declared “grandfathered.” Unfortunately, in the 2011 NDI Draft Guidance, FDA stated that in the absence of supporting evidence, these lists were not enough to serve as an authoritative resource. This decision spurred a diverse set of opinions regarding the best path forward among stakeholders. Has too much time passed to be able to provide FDA with sufficient evidence to make a meaningful list? If a company does have access to the requested evidence, will they use it as an opportunity to make money instead of sharing it openly? Perhaps industry does not have an obligation to do anything and the burden of gathering documentation is instead FDA’s?
Creating Clarity
We’ve had a quarter of a century to think this over. Generally supportive of FDA’s willingness to develop a pre-DSHEA ingredient list, industry recognizes such a list would not only benefit supplement manufacturers, but FDA—and even consumers—as well, so long as it is appropriately crafted and tailored in collaboration with stakeholders.
FDA’s current efforts toward developing an ODI list is an opportunity to create clarity as to the regulatory status of a wide variety of dietary ingredients, but CRN calls for something more: a list that includes the entire universe of ingredients that do not require NDI notification. This family of ingredients includes:
- Pre-DSHEA ingredients
- NDIs filed with no objection since Oct. 15, 1994
- Unaltered ingredients in the food supply
Considering the stakeholder input it has received over the past two and a half decades, FDA is now tasked with conducting a close investigation of the resources available and evaluating the pros and cons of moving forward on this project. In the meantime, the current NDI draft guidance remains the agency’s most current thinking on the topic, and companies would be wise to follow those processes. If a company is unsure about whether an ingredient needs notification, CRN suggests consulting a trade association, a regulatory attorney, or FDA directly. If you ask, you may not like the answer, but at least there will be clarity.
Duffy MacKay, ND, is the senior vice president, scientific & regulatory affairs, Council for Responsible Nutrition (CRN), a leading trade association for the dietary supplement and functional food industry.
