The committee that controls FDA’s purse strings is now turning up the pressure. Will we see change at last? Action Alert!
The House Agriculture Appropriations Committee has released a report that, among other things, chastises the FDA for stalling on the second draft of their New Dietary Ingredient (NDI) guidance. The committee directed the FDA to end this “regulatory uncertainty,” issue a timeline for the NDI guidance, and include stakeholders in the process.
Specifically, the committee told FDA to report back by September 1 on how the agency plans to “develop new methods of communicating with its stakeholders on future actions…including estimated timeframes for when regulations, advisories, and guidances are planned for release.” (NDI is included as an example of “guidances.”) The agency was also told to report back within sixty days of enactment of the Agriculture Appropriations bill with “a timeline on how it intends to re-engage the dietary supplement community to develop a final guidance on what constitutes a NDI.”
This is a tremendously important development. It was ANH-USA’s work with the committee that got them to compel a second draft of the guidance, and it was our lobbyists who helped include the important language in this new report. This would not have been possible without your support and activism! THANK YOU!
You would think that because the House Ag Appropriations Committee controls the FDA’s purse strings, the agency would have to listen to them. However, this same committee directed them to act before, and FDA did very little. Now, because the committee is turning up the volume, it pressures FDA to take action. FDA has now been specifically asked to provide a timeline, which would be hard for them to circumvent. We think it’s likely FDA will recognize that the committee is serious about all of this, and we hope that FDA will stick to the timeframe they provide.
The committee’s mention of an “uncertain regulatory environment” refers to the FDA dragging its feet on the NDI draft guidance. It has been close to two years since FDA submitted its initial draft guidance, and the agency has been promising to work with the supplement community on a second draft since October 2012—eight months ago!
An uncertain regulatory environment is, of course, not good for business. Companies don’t know what they can sell (and invest in) and what they can’t. Manufacturers will be less likely to submit NDIs for new supplements if they are unclear on what the requirements are. This will stifle innovation. And once again, consumers will be the losers.
Also, despite their explicit promises to the contrary, FDA continues to enforce the controversial provisions of the draft guidance by sending out warning letters. For example, it issued letters to ten different companies for, in part, selling supplements that contained synthetic botanicals. The draft guidance says that synthetic botanicals are not considered to be a dietary ingredient at all (much less a new dietary ingredient), and therefore cannot be sold as an ingredient in dietary supplements.
As written, the draft guidance puts a number of synthetic botanicals—all of which have important health benefits—in regulatory limbo, such as the following:
- Epigallocatechin gallate (EGCg): EGCg is a potent antioxidant that is abundant in green tea and that may have therapeutic applications. EGCg is synthesized and commonly used in many supplements for its antioxidative qualities. It can protect the DNA in human cells from ultraviolet and visible radiation-induced damage.
- Allicin: A sulfur compound obtained from garlic. Allicin is generated by the oxidation of diallyl disulfide for use in supplements and could be considered a synthetic botanical. In pure form it has been shown to have antibacterial activity, including multidrug-resistant enterotoxicogenic strains of E. coli; antifungal activity, particularly against Candida albicans; antiparasitic activity, including some major human intestinal protozoan parasites such as entamoeba and giardia; and antiviral activity.
- Lycopene: While this phytochemical occurs abundantly in tomatoes, supplemental lycopene is usually synthesized from enzymes found in algae. Some studies show that lycopene lowers the risk of certain types of cancer and has a strong antioxidative effect.
- L-theanine: This amino acid is found naturally in green tea, but in supplements is derived from fermentation of a tree leaf. In action, the result is chemically and, presumably, biologically identical. However, technically, it is both chemically altered and a synthetic botanical. L-theanine has numerous benefits, including helping to balance brain chemistry, reduce the risk of strokes, and reverse liver damage.
FDA has a history of enforcing its draft guidances via warning letters, even before they are finalized. For example, FDA has not completed its guidance distinguishing between dietary ingredients and beverages, yet the agency has cited the draft guidance in warning letters to supplement companies. And FDA has not issued final guidance on whether a dietary supplement is considered a food (in the context of determining when a food becomes a drug), yet has issued a warning letter to a supplement company on this issue.
Don’t forget what is at stake in all this: FDA’s draft guidance threatens access to 29,000 supplements, and while FDA agreed to reconsider concerns and work with us and the supplement community, we still haven’t seen anything concrete. Our original concerns remain:
- It’s unclear whether multiple NDI notifications will be required for the same ingredient if only the formulation has changed. Companies don’t know when and how they should submit NDI notifications.
- The agency’s NDI draft guidance, as written, is a perversion of congressional intent. When the Dietary Supplement Health and Education Act of 1994 (DSHEA) was written, Congress envisioned a simple notification system that would ensure the safety of supplements, but FDA is trying to turn it into a de facto pre-approval system.
- Additionally, the definition of “grandfathered dietary ingredients” is still unclear. FDA is supposedly working on a list of grandfathered ingredients, but the agency still has not released anything. Supplement companies don’t know whether popular products like resveratrol and P5P will be considered grandfathered and therefore protected—or subject to the endless red tape of NDI submissions.
ANH-USA will continue to actively participate in the process to ensure we receive the best guidance possible from FDA—one that protects the needs of the entire natural health community—in a timely manner.
Action Alert! Please write to House Agriculture Appropriations Committee members, and thank them—in particular, the committee chair, Rep. Robert Aderholt (R-AL), and its ranking member, Rep. Sam Farr (D-CA), for their leadership—for including this important charge to FDA in their report. (Because this Action Alert is being sent only to the committee members, rather than the whole House, you will see a message if you don’t live in one of the committee members’ states.)