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From Jennifer Grebow of Nutritional Outlook, industry experts believe dietary supplement product registration could be incoming. One attorney that assisted in drafting the Dietary Supplement Health and Education Act of 1994 (DSHEA) noted that the industry is moving towards a mandatory product listing. The registry is needed as a way for the industry to self-regulate itself.
The reasoning is that current regulations are not enough and a mandatory registry would require manufacturers to submit a full list of products available on the market that also includes ingredients and any subsidiaries that oversee distribution and marketing.
In turn, the Food and Drug Administration (FDA) would have a comprehensive understanding of all the products on the market and would in turn help the agency to focus on illegal products and companies running afoul of regulations.
The attorney provides a notable example of the necessity of the registry. If the FDA wanted to stop poor quality products being imported from China, how would they be able to do that? As of right now, the FDA wouldn’t know where to start, but with a complete registry, regulators would be able to track down specific ingredients or companies. The registry would also help the FDA track products coming from specific facilities and the status of a facility’s inspection.
Finally, companies must file a New Dietary Ingredient (NDI) submission for ingredients not available on the market prior to DSHEA’s enactment date of October 15th, 1994. Companies must demonstrate in the NDI filing that an ingredient is safe and effective for consumption. However, the FDA does not have complete records of all the ingredients available before October 15th, 1994. For companies, a registry would potentially save them the time and money necessary to file the NDI.
Would the dietary supplement industry support a mandatory registry?
Some companies want their secret ingredients to remain a secret to gain a competitive edge. Others believe the industry should empower consumers by providing transparency with ingredients and products. In other industries, such as over-the-counter (OTC) drugs, a mandatory registry exists, and companies are leveraging it as a benefit rather than a burden.
Though the registry is not yet a reality or in the works, companies can leverage InstantGMP™ MES to provide consumers with thorough information regarding ingredient sources, quality, and product information. Learn more about the benefits of InstantGMP™ MES and see the software in action.