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Editorial: Industry Must Support AER Legislation

By Len Monheit

Earlier this week, Bill S. 3546 ‘The Dietary Supplement and Non-Prescription Drug Consumer Protection Act’, was introduced by Senators Orrin Hatch (R-UT), Richard Durbin (D-IL), Tom Harkin (D-IA), Mike Enzi (R-WY) and Edward Kennedy (D-MA). S. 3546 covering the mandatory reporting of serious adverse events related to the consumption of dietary supplements. The Bill is the outcome of bipartisan efforts and significant industry involvement, and requires companies to include on their products’ labels an address or phone number through which consumers can report adverse events that they associate with their use of a supplement or OTC drug. Companies will be obliged to inform FDA of any serious adverse event reports they receive within 15 business days. The legislation, as introduced, also assures companies that file reports that any submission they make to the FDA will not be considered an admission that their products caused or contributed to the reported event, and that the privacy of individuals will be protected to prevent any misuse of the system.

The bill is expected to be reviewed in the Health, Education, Labor and Pensions (HELP) Committee before the end of June.

The legislation was hailed and supported in releases issued by the United Natural Products Alliance (UNPA), The Council for Responsible Nutrition (CRN), the National Nutritional Foods Association, and the American Herbal Products Association (AHPA).

The statement issued by NNFA focuses on some of the key elements that make this proposed legislation supportable by industry, including the fact that the requirements for reporting are limited to serious adverse events, the bill does not require retailers to report adverse events, it includes OTC drugs, is limited to products sold in the United States and includes a state preemption provision, meaning that the potential multiple laws in different states will not be an issue and manufacturers will only have to comply with a single, federal law.

It certainly sounds like a reasoned, measured approach and an opportunity for industry to show both responsibility and unity. As UNPA points out in its release, the proposed system allows for early warning of serious health issues, and as NNFA notes, this legislation will help to change the perception that industry is not well-regulated and that the data should ultimately help to prove overall and individual supplement safety.

First of all, kudos to the industry trade associations for quickly getting off the mark with their positions on the legislation. I hope that support and endorsement continues to appear from industry sources so that the media continues to realize that industry’s position is active and not passive.

I agree with the point raised earlier that this is a solid chance to show, as an industry, what has been lacking in the past - unity and solidarity. Secondly, and perhaps most importantly, to not show active and vocal support would give our detractors the evidence they want to reaffirm their convictions about our industry - that we are not responsible and not concerned about public health and safety.

Through the trade associations, industry has been quite active in this Bill’s development. Perhaps even more importantly, some groups have been working ahead of time on communications and messaging strategy to ensure that the mainstream media ‘got it right’. A clear example of this was pickup by the Salt Lake Tribune, the day of the Bill’s introduction, with a headline which read “Supplement backers like bill, Senate proposal would require makers to report health problems tied to products” ( including an introduction that completely placed the issue for many in context as it said,

“Champions of dietary supplements have long sneered at the suggestion that vitamins, minerals and other supplements should be treated like drugs. Yet there they were Wednesday, alongside consumer watchdogs, cheering the introduction of a bill that would do just that, at least when it comes to reporting serious health problems associated with their products.”

This legislation allows industry to work alongside traditional adversaries, in a similar manner as the Bill’s architects did (Senators Orrin Hatch (R-UT), Richard Durbin (D-IL), Tom Harkin (D-IA), Mike Enzi (R-WY) and Edward Kennedy (D-MA).

The Center for Science in the Public Interest (CSPI) commented, “Manufacturers of dietary supplements should absolutely be required to report serious adverse reactions to the Food and Drug Administration. That’s why the Center for Science in the Public Interest strongly supports the bipartisan legislation…” Incidentally, the CSPI comment also strongly encourages sufficient funding to the FDA so that the Agency can timely respond to reports of adverse reactions.

We all expect there to be very few serious adverse event reports. Even so, having this bill in place will provide another clear answer to point out that not only is industry ‘regulated’, it actively supports and believes in the regulations it is bound by.

I’m firmly convinced that we’ll continue to have our battles over adequate and appropriate regulation – that issue is not yet resolved, nor will this bill’s hopefully speedy passage bring automatic credibility and legitimacy, or change some of the media’s perspectives. It removes a key argument for the immediate rewriting or dismantling of DSHEA, and as I’ll state again in both positive and negative terms, it allows the industry to clearly indicate its sense of responsibility, while a lack of active support or endorsement, or perhaps even expressions of discontent over Bill S. 3546, merely reinforces a perception that this industry is in it for ‘quick bucks’ and has no interest in consumer health and safety.

Let’s get it right.

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