By Len Monheit |
As 2003 ended, the US FDA announced its intention to implement a rule banning the herbal stimulant and weight loss ingredient ephedra, and urged consumers to immediately stop using these products. Ironically, many consumers took this notice quite seriously, but instead of ceasing product use, they immediately stocked up on ephedra-based products while they were still available.
FDA intends to have the rule published in the next several weeks, in which case, 60 days later, it will become law. FDA has issued notices to over 60 manufacturers so that they can prepare for the eventual recall and take all appropriate steps. CRN (Council for Responsible Nutrition has indicated it has no plans to oppose the ban, and AHPA (American Herbal Products Association) has said it will evaluate the information FDA has used to make its assessment of ephedra risks and danger. AHPA has also indicated it will continue to pursue with the FDA the serious event notification system it has already proposed, and adverse event reporting is quickly becoming one of the hottest issues facing the industry, and it’s only a matter of time before it becomes a media rallying cry as well. It is already a key piece of Senator Durbin’s proposed bill - S. 722.
Many within the dietary supplement industry have indicated they will fight the ban with legal action for two key reasons - trailing litigation and precedent. The first issue is probably legitimate, and in fact, several larger manufacturers have hundreds of millions of dollars set aside (Numico, previous owners of GNC, have reported over $250 million for each of 2003 and 2002), and if the ban does become law, lawsuits may be a subsequent step. Just what the responsibilities, liabilities, obligations and settlements would be is anyone's guess.
The second issue illustrates industry's no-win situation. FDA is clearly seeking a precedent and it is quite likely that other products will be tested similarly for danger and risk, including replacement products which began hitting store shelves early in 2003.
The fact remains that DSHEA prescribes the method to be used, and in its efforts to enforce the public will (as it says), FDA has followed the steps it must in order to take a product off the market. If industry challenges the precedent and process that now establishes a mechanism for FDA to remove a product from the marketplace, and is even partially successful, then obviously both law and process are wrong and so more authority must be given to the FDA and more importantly, DSHEA, as presently written, must be seriously flawed.
It’s a trap, this is a two arena battle and the industry, if it wins on one of the fronts, will surely lose in the other. Success in a legal challenge which preempts the ban or even delays FDA's ability to 'enforce the public will' may very well be the event which triggers the dismantling of DSHEA.
Center stage for this battle is really in the media, and anyone who doesn’t realize that is missing a key element of the war. Editorial pieces are appearing with increasing frequency about the ‘hand-cuffed’ and ‘powerless’ FDA and its limited authority, and the lengthy and tedious mechanism that must be followed to ban a product.
WASHINGTON — The pending ban on the herb ephedra sends a signal to a large and loosely regulated industry that the government is willing to crack down on risky dietary supplements
But unless current law is changed, such bans may not occur very often.
Federal law makes it very difficult for health officials to curb sales of dietary supplements that seem dangerous, far harder than it is to curb risky drugs, says Health and Human Services Secretary Tommy Thompson (search), who wants Congress to change that.
The FDA first proposed warning labels and a dosage curb for ephedra in 1997, but the powerful supplement industry blocked the move.
And critics note another fundamental legal flaw: Because DSHEA deregulated the entire supplement industry, consumers can't be sure that the ingredients listed on the outside of a bottle reflect what is inside.
Prove supplements' safety
It's alarming that the Food and Drug Administration had to wait until people died before it could order a dangerous diet supplement taken off the market. Nationwide, ephedra has been linked to 155 human deaths and 16,000 serious illnesses. To put the figures in perspective, ephedra may have killed more people than mad cow disease (153 deaths worldwide) has in nearly two decades.
Congress hog-tied the FDA, rendering it nearly powerless to protect consumers from unregulated and unproven diet supplements.
Congress rolled over and played dead in 1994, after supplement industry lobbyists poured big bucks into congressional re-election campaigns.
Consumers should be told that when it comes to diet supplements, federal regulation is a throwback to the bad old days of buyer beware.
Press of Atlantic City:
But a nationwide ephedra ban is necessary, and it should have the beneficial side effect of promoting new debate on the 1994 Dietary Supplements and Health Education Act, which rolled back supplement regulation and allowed the industry to boom.
Our position is: Dietary supplements need the same scientific testing and standards that regulate over-the-counter drugs.
U.S. Lawmakers Seek New Diet Supplement Rules After Ephedra Ban
Dec. 31 (Bloomberg) -- House and Senate members said they'll still seek tougher rules on diet supplements after the Food and Drug Administration announced a plan to ban ephedra, following reports of the deaths of 155 people linked to the herbal product.
The FDA said it took years for it to accumulate enough evidence before it could ban ephedra.
A 1994 diet-supplement law makes the agency prove a product is unsafe before it can act.
“Ephedra is a small part of this, the real issue is perception of FDA’s ability to protect consumers under the present law”
Make no mistake about it - The latest salvos in industry's media battle have been fired. Reading between the lines, it's easy to see the perception being developed that FDA has squandered time and possibly lives while dotting 'i's' and crossing 't's' to ensure this ban stood up to the legal challenge and followed what was required under DSHEA. If the 'powerful' supplement industry lobby is able to thwart the FDA under DSHEA, then the law is seriously flawed. Even a delay in the ban would be disastrous to the industry and would give DSHEA opponents all the momentum they require in Congress, in the Senate and most importantly in the media- which would absolutely lambaste the industry.
Many companies voluntarily withdrew from ephedra over the past year, and CRN has indicated that none of its member companies presently sell ephedra-based products. Industry’s position has beento promote mandatory warning labels and strict adherence to use guidelines. There have been calls for a complete industry withdrawal from ephedra, but the same voices that will likely now issue the legal challenge to FDA’s ban were the same ones speaking out against this voluntary, proactive action and perhaps in retrospect, they increased the vulnerability of DSHEA and the entire industry.
Senator Orrin Hatch, one of DSHEA’s key authors, supports the ban, according to an article in Utah’s Vernal Express, "Today's action reassures me that it will now be a priority of HHS and FDA to police the marketplace and apply acceptable scientific safety standards provided under DSHEA as necessary. I have been assured by the FDA that this determination is a reasonable application of the law's unreasonable risk authority provided to FDA." Hatch also commended Commissioner McClellan and Secretary Thompson for having the courage to use the safety standards under DSHEA.
There may be still time to blunt the attack. This industry is about more than ephedra and weight loss products, but this category, for the past few years, has fueled anti-industry sentiment – on Capitol Hill and with consumers. It’s never been more important for industry to show and promote its best practices, history of responsible actions and support for FDA’s intentions.
We knew that 2004 would be a critical year on the legislative front. We’re now seeing a well thought out, multi-pronged approach, and we need to recognize it for what it is.