FDA considers dietary supplements that contain new dietary ingredients and that have not submitted new dietary ingredient Notifications to be adulterated. Any supplement that is considered to be adulterated can be subject to enforcement action by the FDA.
A new dietary ingredient is a dietary ingredient that was not marketed in the United States in a dietary supplement before October 15, 1994. If a company is using a new dietary ingredient in their product, the onus is on them to provide FDA with evidence of the dietary ingredient’s safety or history of use, presented in the form of a new dietary ingredient Notification1. When submitting a pre-market notification you must provide data that indicates either: (i) a history of safe use or evidence establishing safety or (ii) data to indicate that the ingredient has been used in the food supply as an article used in food that has not been chemically altered.
The FDA does not have an authoritative list of dietary ingredients that were marketed as dietary supplements before October 15, 1994, placing the burden on industry to determine if the dietary ingredient in question was marketed before that date. However, to aid the industry FDA released a guidance document in July, 2011 to better define the process2. After October 15, 1994 industry associations such as the American Herbal Products Association (AHPA) and Council for Responsible Nutrition (CRN) published lists of dietary ingredients believed to have been marketed before October 15, 1994. However, these industry association lists are not approved or recognized officially by the FDA but are generally accepted by industry. If the ingredient in question is not contained within these industry association lists you either need to provide evidence to the FDA to prove that it is not a new ingredient or you must file a Notification at least 75 days before introducing the supplement with the new dietary ingredient present into interstate commerce or delivering it for introduction into interstate commerce.
As part of the new dietary ingredient premarket notification FDA requires the following information to be submitted:
A common question regarding new dietary ingredients is determining what are the limits and definition that apply to a dietary ingredient being chemically altered. Currently, there is no set definition for defining a dietary ingredient as chemically altered in any FDA draft guidance documents; however the FDA has provided examples of what they consider to be chemically altered. The following are examples of processes that FDA would likely consider to involve chemical alteration.
A safe assumption to determine whether your dietary ingredient would classify as a new dietary ingredient due to chemical alteration is to look at the chemical structure of the dietary ingredient that was marketed before October 15, 1994 and compare it with the chemical structure of your compound, if both structures are not completely identical you may have to submit a Notification.
Although, the FDA has released a draft guidance document on new dietary ingredients there still remains a lot of ambiguity regarding whether an ingredient is a considered new and hence requires a Notification to be submitted. As such trade organizations such as the CRN, Natural Product Association (NPA), AHPA and United Natural Products Alliance (UNPA) have raised the following five issues that the FDA has agreed to address in their next draft of the new dietary ingredients guidance document
With all of these factors to consider when discovering that you have a new dietary ingredient in your product, reformulation may be a consideration. However, the goal of the FDA is not to slow down industry progress and restrict new and innovative products from the market but to ensure public safety. At dicentra we employ a team of scientific and regulatory experts that are available to help you determine whether your ingredient is a new dietary ingredient and if so are able to aid in the completion of a Notification.
References: 1. http://www.health.gov/dietsupp/ch1.htm 2. http://www.fda.gov/food/guidancecomplianceregulatoryinformation/guidancedocuments/dietarysupplements/ucm257563.htm 3. http://www.naturalproductsinsider.com/news/2012/06/fda-reportedly-to-revisit-ndi-draft-guidance.aspx