We need to ask Congress to review the FDA’s absurd claims and carefully watch over the FDA’s draft NDI (supplement) guidance process. Please join us in this nationwide campaign!
Previously we announced a Call-In Lobbying Day for Thursday, September 8. We’re asking each of you—members, grassroots activists, readers, and friends—to set some time aside on September 8 to phone your senators and representatives and voice your opposition to the NDI (dietary supplement) guidance. Tell them why you’re upset over the NDI guidance, and ask them to direct the FDA to carefully review their draft guidance and hold hearings at the end of the review process unless the FDA amends the guidance to reflect DSHEA (and Congress’s) stated values and goals. The FDA is clearly overreaching its authority, and the logic of its arguments in the guidance is questionable at best. Congress has FDA oversight and needs to review the agency’s actions in creating this new guidance.
Just go to this page—it will give you talking points for your conversation with your legislators’ offices, and has an interactive feature to look up your senators’ and representative’s names and phone numbers just by typing in your ZIP code.
We recently submitted our comments to the FDA in response to the first of two requests from the FDA for information, outlining the immense burden created by the dietary supplement draft guidance. Other concerned parties submitted comments in this first round as well. FDA responded with some pretty ludicrous logic.
The agency claims it will take only 20 hours per NDI notification. This is an absurd claim, considering the extensive paperwork and safety studies they require in the new draft guidance. Furthermore, as we have mentioned many times before, FDA refuses to file (that is, approve) most of the NDI notifications that are submitted, claiming that the notifications are “incomplete” or “inadequate.” So even though FDA rejects the majority of applications because they are incomplete, they really expect a supplement company to take only 20 hours per notification?
In addition, the FDA expects only 55 new NDI notifications per year. This is after officials stated in the guidance that there are 55,600 dietary supplements on the market. Something is very wrong with their math! Experts predict as many as 125,000 notifications.
Moreover, the FDA has not accounted for any of the costs to hire the expert consultants, scientists, etc., who will be required to successfully draft the NDI notifications. And they seriously think this won’t add any significant burden to industry?
Of course the ultimate issue here isn’t the cost or burden on supplement producers. The NDI guidance is really the first step toward an FDA approval process that will change the law governing supplements—and in the long run both sharply reduce the number of supplements sold and sharply increase the cost of those surviving.
We need Congress’s involvement, oversight, and correction. Join your fellow Americans in phoning your legislators on September 8 and asking them to stand against the FDA’s new supplement guidance!