NDI Supplement Guidance is Just a Bait-and-Switch—and Time Is Running Out to Stop It!October 25, 2011
Only 38 more days to tell FDA and Congress that the proposed rules for supplements could lead to the elimination of thousands of supplements and make the surviving ones much more expensive.
When FDA issued their draft guidance for New Dietary Ingredients (that is, supplements), the agency was perverting congressional intent—the congressmen who wrote the original legislation even told the FDA commissioner before the guidance was issued that it needed to be fully consistent with DSHEA! FDA was also attempting to circumvent the notification system Congress intended by instituting a scheme that mirrors the Waxman supplement pre-approval system, introduced in 1993, which DSHEA was intended to stop.
Here’s some important background for you.
Supplement and integrative medicine champion Sen. Orrin Hatch made this statement when he introduced the bill for DSHEA, the Dietary Supplement Health and Education Act of 1994:
In our free market society, consumers should be able to purchase dietary supplements and companies should be able to sell these products so long as the labeling and advertising are truthful, non-misleading, and there exists a reasonable scientific basis for product claims.
Unfortunately, not everyone in our federal government shares these views. For more than three decades, FDA has tried to restrict severely the ability of the dietary supplement industry to sell and market its products and, consequently, the ability of consumers to buy them. The agency has repeatedly attempted to impose unnecessarily stringent standards that would leave many if not most supplement companies with no practical choice but to close their doors.
In sharp contrast, Rep. Henry Waxman wanted dietary ingredients and nutritional supplements to be considered food additives and therefore subject to FDA approval—not unlike the system that is used for drugs. So Waxman introduced the Dietary Supplement Access and Claims Moratorium Act of 1993. This bill would have amended the food additive definition to include dietary ingredients (supplements)—thereby making supplements subject to the food additive approval process.
Happily, cooler heads in Congress prevailed. Sen. Hatch explicitly stated:
As you know, [DSHEA] makes clear that dietary supplements are not food additives or drugs, and that the burden of proof shall be on the FDA to prove that a product is unsafe.
Consequently, when DSHEA was passed, dietary ingredients were specifically exempted from the definition of “food additives,” making supplements not subject to FDA pre-approval. All that was needed was a simple notification.
Now FDA has offered its draft guidance—which attempts to circumvent DSHEA as it was passed and create a new pre-approval system. Everything about this proposal is a perversion of congressional intent, and will (as Sen. Hatch told the world eighteen years ago) severely restrict your ability to buy nutritional supplements and leave many—if not most—supplement companies with no practical choice but to close their doors.
Time is running out—the comment period ends on December 2! Help us protect your access to supplements. We need everyone reading this to send their message to Congress and FDA right now to make sure the FDA and Waxman don’t win! Take action today!