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Spotlight: Synthetic Botanicals and the 2016 Draft NDI Guidance

Last updated: August-20,2019

Spotlight: Synthetic Botanicals and the 2016 Draft NDI Guidance

Since the FDA released it's updated draft guidance for New Dietary Ingredients (NDIs) and "related issues" back in August of 2016, the dietary supplement industry has been working to understand the guidelines and how, if any of the recommendations listed become laws, the industry will be affected.

Of all the conversations that have started as a result of the NDI draft release, the issues and nature of how the update may impact how our industry uses synthetic botanical ingredients made it's way into the spotlight more than once.

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Always here to help keep you in the loop, we're taking a closer look what it about the updated draft guidance that's captured the attention of dietary supplement brands and manufacturers that work with botanicals and synthetic botanicals.

Synthetic Botanicals and the 2016 Draft NDI Guidance

One place where industry advocates and the FDA have a long standing tradition of not seeing eye-to-eye is on the relevance and categorization of synthetic ingredients.

In both the most recent update and the July 2011 update, the FDA asserted (and continues to assert) that synthetic versions of botanical constituents should not be qualified as botanical dietary ingredients (citing section 201(ff)(1)(C) of the post-DSHEA version of the Federal Food, Drug & Cosmetic Act (FD&C)).

Since the FDA first took this stance, industry insiders and advocates have countered with a fairly simple argument: If a company or manufacturer follows the appropriate channels for submitting a synthetic botanical (that's been through all of the necessary R&D paces) as an NDI, why shouldn't that ingredient be considered any differently than it's non-synthetic botanical counterpart?

Adding to the Equation: Gaining GRAS Status

Acknowledging that much of what has been included in the FDA draft guidelines (at least to date) are only recommendations. At this point in time, the majority have not been implemented as federal regulations.

That said, one approach that's currently being used by those within the dietary supplement industry to classify synthetic botanical ingredients in a way that makes them more accessible and acceptable for use in products is by pushing for their synthetic constituent to gain GRAS (generally recognized as safe) status.

The Future for Synthetic Botanical Ingredients

As of now, there's way for us to know for certain how (or if) the FDA will change its stance on synthetic botanical and herbal ingredients. What we can do is keep an ear to the ground and take small steps (when possible) towards meeting the recommendations laid out by the FDA.

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About the Author:

Melissa DellaBartolomea

Melissa DellaBartolomea was the resident Content Marketing Specialist at NutraScience Labs from February 2016 to July 2018. Driven by a passion for the world of written, visual, and digital media, she's dedicated herself to keeping up with all things nutraceutical. From ingredient insights to the latest in contract manufacturing regulations and trends, her mission is to provide our readers (like you) with the stories and knowledge they need to fuel long-term growth and nutraceutical industry success.