Alcrea Health believes in the principles behind the Draft Guidance—namely, ensuring consumer safety. However, we question why, after 17 years, FDA has published such stringent guidelines.  We do not believe that a consumer safety crisis exists to justify such action. Let’s take a look at the topics in question…

FDA’s Requirement for NDI Notification Based on Products Instead of Ingredients

The Draft Guidance requires submission of an NDI notification by each and every manufacturer or distributor for each and every product that contains an NDI, rather than relying on general safety information and dosage parameters per ingredient for all products.

Theoretically, any variation whatsoever to the ingredients of a dietary supplement containing an NDI would require a new NDI notification. This approach is unwarranted.  FDA has historically permitted notifications based on ingredients, not finished products. For example, bulk ingredient notifications from suppliers provided recommended ranges for safe use of the NDI in finished products manufactured by their customers

Companies that rightfully bypassed this step, relying on a previous FDA acknowledgement for an ingredient, should not now be required to come forward and submit a notification. Such a result would generate a regulatory logjam with no benefit to the consumer.

Treatment of “Chemically-Altered”

Processes that would not render an ingredient “chemically-altered” is unnecessarily limited. It appears to be generated using 1994 standards without accounting for any processes developed or improved since.

By requiring excess NDI notifications in this way, FDA would drive up production costs and stifle innovation as manufacturers would forego new technologies.

Treatment of Probiotics

Probiotics are a lawful and viable category of dietary ingredients. However, the Draft Guidance’s treatment of probiotics created using advancements in fermentation media causes concern of unnecessary exclusion of safe and effective species or strains.

Advancements in fermentation or production processes designed to improve culture yield and stability do not create an NDI.

Treatment of Synthetic Herbal and Botanical Ingredients

We disagree with FDA’s proposed treatment of synthetic herbal and botanical ingredients.  DSHEA’s definition of a dietary supplement outlines the ingredients a product can contain, including a vitamin, a mineral, an herb or other botanical, an amino acid.

Because synthetic versions of vitamins, minerals, and amino acids are already permitted, it is arbitrary and illogical to exclude synthetic versions of herbs and other botanicals in the Draft Guidance. As such, we hope FDA reconsiders this position.

The Draft Guidance Creates “Homogenized Products” and Discourages Innovation

We believe that if the Draft Guidance is adopted in its current form, the resources required to submit redundant, product-based NDI notifications will limit innovation by creating an environment where pre-approved, “canned” products will become the norm due to a less resistant path to market. While unfortunate, we believe this is a practical reality. This policy would encourage a marketplace lacking product differentiation where the consumer will have limited access to health-promoting supplements, contrary to Congress’s intent as conveyed in DSHEA.