Supplements Still in Peril

Over the past year, we fought four different Congressional bills that would have affected your access to supplements. In our Action Alert, we need your help to educate our lawmakers, most of whom know little or nothing about existing supplement regulation or why supplements are not drugs.

As successful as you have been in defending supplements on Capitol Hill this year, anti-supplement members of Congress are still playing on the offense. As Congressman Henry Waxman, one of the leaders of the group trying to turn supplements into drugs, once said that nothing is ever “settled for good” in Washington.
Of the four pieces of legislation below, only the Food Safety Bill is still an immediate threat and so far it keeps being delayed. But even the bad ideas you have defeated could easily come back.

• Senator McCain’s Dietary Supplement Safety Act (S. 3002) is no longer supported by McCain himself, but cannot be formally withdrawn and so remains for this session.
• The Wall Street Reform and Consumer Protection Act of 2009 (H.R. 4173), which passed the House in late 2009, included a buried provision written in impossible-to-follow legalese that would have drastically expanded the powers of the Federal Trade Commission, powers that would have been used against supplements. Although you stopped it in the Senate and in conference committee, it could still be added to another bill.
• The FDA Food Safety Modernization Act (S. 510). You succeeded in getting language added that would protect us from sliding down a slippery slope toward harmonizing US standards for supplements with the irrationally restrictive European standards—under rules set by the global Codex Alimentarius. Other provisions of the bill we still oppose, but it has been sitting on the Senate calendar for ten months with no activity. One possibility is that it will emerge and be reconciled with the House bill in the very dangerous lame duck session after the fall elections, when defeated or retired legislators can take positions without worry about voter reaction.
• The Food Safety Enhancement Act (H.R. 2749). This is a terrible bill. It has passed the House, so the last chance to stop its toxic provisions is in the House–Senate Conference when it eventually comes. Among the worst provisions, it includes jail time—up to 10 years—for “misbranding” or “adulterating” supplements. And the definitions are very broad: “adulteration” includes recordkeeping violations, while “misbranding” includes citing peer-reviewed science about the benefits of a dietary supplement. This new threat of sanctions (only in the House bill, not the Senate’s) would give the FDA a hammer with which to threaten and coerce companies engaging in completely legal activities.

In the case of all the bills above, we have been successful so far. But we have been fighting in a defensive mode. If we stay only on the defense, we will eventually lose. It is clear that we need to take action—to be proactive—and educate Congress on the supplement regulation issue. In order to prevent new legislative efforts to implement duplicative, unnecessary, and expensive regulations that could drastically reduce your access to health-giving supplements, we need your help to tell Congress that dietary supplements are already regulated!
That’s right: contrary to what the media has been saying (and many members of Congress believe), dietary supplements are indeed fully regulated. The FDA has complete authority to regulate supplements in three important ways:

1. It can take any supplement off the the market that is unsafe, mislabeled, misbranded, adulterated, or makes false or misleading claims. (The FTC also has the power to stop any fraudulent advertising.)
2. It is charged with enforcing the 1994 Dietary Supplement Health and Education Act (DSHEA), which holds supplement manufacturers to “good manufacturing practices” (industry standards for product quality) as defined by the FDA itself.
3. It collects and takes any necessary action based on “adverse event reports,” that is, any reported negative reactions to dietary supplements.

Please let your senators and your representative know that supplements are not drugs. It is nonsensical to treat them as drugs. Importantly, supplements are natural substances; therefore they cannot be patented; therefore to subject them to the vast cost of FDA approval would simply drive supplement producers out of business, leaving drug companies with a complete monopoly. Moreover, although they are not drugs, supplements are already fully regulated. More legislation is not needed. Please help deliver this message where it is needed. Please TAKE ACTION now.