The Dietary Supplements Health and Education Act of 1994 (DSHEA) amended previous statutes to encompass dietary supplement-specific provisions including the definition of a “dietary supplement,” product safety, nutritional statements and claims, ingredient and nutritional labeling, good manufacturing procedures and the classification of “new” dietary ingredients. While giving manufacturers the ability to use select, approved claims, it posed restrictions on the industry and gave the Food and Drug Administration (FDA) significant authority to regulate the products put on the market. Yet it continues to be heavily scrutinized and criticized for being a “shield” for “unregulated” and “renegade” marketers. 

As the FDA recently released a draft of its New Dietary Ingredient (NDI) guidance—something that has raised a great deal of concern within the industry as it seems to be in direct conflict with the core tenants of DSHEA—NIE conducted a roundtable with trade associations, suppliers and manufacturers to reflect on where the scrutiny of DSHEA and, in turn, the industry stems from; milestone attacks and defenses of this important piece of legislation; and how the industry must be mindful going forward to ensure DSHEA remains intact and, most importantly, to silence critics.

NIE: Where does the criticism of DSHEA stem from, and is it warranted? 

Blumenthal: There are a variety of reasons why DSHEA is under continued scrutiny. One is that there are those who are basically opposed to the value proposition that the dietary supplement and natural health community attempt to offer; such people tend to dismiss a priori any evidence from positive clinical trials and/or systematic reviews and meta-analyses showing some benefit for an herb, phytomedicinal extract, dietary supplements, etc. In addition, the inappropriate and unsubstantiable claims made by some marketers, the product quality problems with some marketers and the adulteration of ingredients all tend to provide evidence for nay-sayers to dismiss this category. 

McGuffin: Critics believe that supplements should be regulated much more like drugs, especially as regards to FDA pre-approval of product formulations and claims. I do believe, though, that the chance for criticism to be broadly accepted may be inversely related to actual and perceived industry compliance with the regulations that exist under DSHEA. In other words, when problems with supplements are minimal, criticisms are less credible to consumers, whereas when attention is given to bad products and practices, it is easier to get the public’s attention. 

Gay: Some of [the criticism] comes from those who never thought DSHEA should have passed in the first place, but other scrutiny is invited by those outliers who do things like spiking supplements with drugs. The concern about spiking is fair, but the answer is not to punish the great majority of the industry that is law-abiding. The answer is to police the lawbreakers. 

Dijkstra: The dietary supplement industry has been battered by the news media. It is unfortunate that a few bad apples have overshadowed more positive discussions about healthful products that are designed to help people support a healthy lifestyle. Unscrupulous companies selling low-quality products drag down the reputation of the industry and the responsible companies that offer safe, scientifically backed supplements. Wild claims lacking scientific backing ultimately hurt the whole industry and increases consumer skepticism in dietary supplements and functional foods and beverages. Wild claims combined with negative media coverage have made many consumers wary. Unfortunately, because of the few companies that continue to put marketing before research, the industry is coming under growing scrutiny by FDA, FTC and Congress. 

Kohli: The ones who do most of the finger pointing are the ones who want to try to portray DSHEA as the entry to market snake oil. Unfortunately, this mindset is picked up on by lazy media that calls us “unregulated,” and accuses DSHEA as being a tool “for them (us) to do anything they (we) want.” 

Being under constant scrutiny, it is naturally easy to be defensive and think it’s unfair. However, some criticism may have merit and when it does, it should make us even better, upping the bar. We should weigh criticism and take it under advisement when it makes sense. The only way to put an end to it is to continue to self-regulate and be wary of criticism that can actually be constructive. 

Pontiakos: Any industry is open to criticism—on many levels it’s good and healthy if that scrutiny is based on fact. What’s interesting is that the attacks hide behind misinformation—that they’re trying to protect children’s safety or the safety of the elderly. Basically, it sound bites well. But what I find disturbing is that many in Congress will attack this industry with limited knowledge of its incredible benefits, efficacy and the economic strength it brings to the country. 

NIE: If DSHEA itself is not the problem, then what is? 

What the FDA needs to do is to enforce the current DSHEA law to its fullest. If the FDA had had all of the resources it needed to fully implement DSHEA from its inception, then they would have been able to reign in the few problematic marketers. It’s the unfortunate actions of a few that has created the impression that the natural products industry is unregulated and that issues of safety and compliance are endemic

NIE: Since DSHEA’s inception, how have critics worked to dismantle it, and how has the industry reacted in its defense? 

McGuffin: Senator Durbin’s 2003 bill (S. 722, the Dietary Supplement Safety Act) comes to mind. I testified before Sen. Durbin at a Senate hearing in 2002 and was able to create a relationship with his staff. Through that relationship AHPA was able to foster an environment in which the legislation that was later adopted on serious adverse event reporting for supplements included the protections needed by the industry, much as the drug industry already enjoyed.

AHPA also worked closely last year with Senator’s Hatch and Harkin and numerous other trade associations to remove the threats presented by Senator McCain’s 2010 bill (S. 3002, The Dietary Supplement Safety Act), and we are doing the same this year to address the new Durbin bill (S. 1310, the Dietary Supplement Labeling Act). 

On the matter of the proliferation of drug-spiked products that masquerade as dietary supplements, AHPA has developed a website that was designed to keep this issue in front of the industry as we work cooperatively with FDA to try to resolve this problem.

Gay: The industry reacted quite quickly and strongly to the threat of S. 3002. NPA has a powerful grassroots network of manufacturers, suppliers and retailers who we can call upon to make their voices heard on Capitol Hill. 

Green: And let’s not forget state level Issues, like California Prop 65, New York State Assembly’s A2762 (originally introduced in 2003 and sponsored by Assemblyman Felix Ortiz) and, in 2009, the New York State Assembly introduced A2957. Having state-mandated labeling laws makes selling and marketing national brands of dietary supplements much less profitable and often cost-prohibitive. This alone can have a potentially chilling effect on how national brands operate from state-to-state in the U.S.

NIE: One of the loudest and reoccurring criticisms is that of safety. How does the industry respond? 

Blumenthal: Of course many of these people [DSHEA critics] see the world in a medical/pharmaceutical gestalt, so any law or regulatory system that does not hold dietary supplements to a drug-like, pre-market approval standard is suspect, despite the unfortunate fact that many drugs, which do go through an imperfect pre-market review and approval system for safety and efficacy, are later removed due to safety problems.

Mister: CRN was very much involved in getting ephedra off the market—and it was industry’s decision to let the ingredient go. Our association was also responsible for shepherding the adverse event reporting (AER) bill in through Congress, and for leaning on FDA until good manufacturing practices (GMPs) were issued. 

Green: Our trade organizations have taken the lead by instituting self-regulatory initiatives to keep their members living up to the tenets of DSHEA. And we’ve done a pretty good job at selfregulation and safety. For example, according to Poison Control Centers, there have never been more than 20 deaths in a year tied to dietary supplements, and that was more than a decade ago. In 2007, there was one. In 2008—the most recent year they have reports—zero. These are remarkable statistics, especially when compared with foods and prescription and overthe- counter drugs.

Pontiakos: I don’t understand how any lucid congressional legislator can attack the industry on the basis of what they have when we’ve been very successful promoting safety. Have there been issues? Yes, but we’ve responded very well. In regards to safety, consumers are getting far less from pharma and other industries.

NIE: The FDA’s NDI Guidance seems to be a timely reminder of how fragile DSHEA can be without defenders. What are some of the primary concerns with the draft? 

McGuffin: Some parts of the draft will Be useful to companies that want to launch new dietary ingredients, as it compiles FDA’s experience over the last 17 years and suggests steps that companies can take to meet FDA’s expectations when filing a notification. Other parts of the draft, however, present reasons for real concern, should these not be modified before any final guidance is issued. For example, FDA has taken the position that all dietary supplements that contain any NDI is subject to the notification requirements, but AHPA does not agree that this is what the law actually says. The guidance also implies that companies that are selling old dietary ingredients, such as vitamin C or chamomile, need to have actual documentation in the form of a dated record that the ingredient was in the market before 1994, but the law does not say that.

Mister: The NDI draft guidance dismisses the intent of DSHEA and it ignores the realities of 2011. The reality is that FDA is lacking resources and would likely not be able to keep up with an increase in receipt of NDI notifications under this draft guidance. We must not forget that both safety and consumer access are significant elements— and DSHEA maintains a balance between both. When I read the NDI draft guidance, I see an agency that needs to be more mindful of the consumer access part.

NIE: How would the industry like to see the NDI draft amended to be more in line with the intent of DSHEA? 

Blumenthal: It is probably in the best interests of all concerned if the FDA were to make some agreements with industry groups regarding establishing a mutually agreed upon baseline list of old dietary ingredients. Further, we are not certain that FDA’s apparent policy that any solvent other than water and/or ethyl alcohol can trigger an NDI status is in the interests of the consumer, i.e., particularly if there is no evidence of safety problems associated with a different solvent—for example, supercritical carbon dioxide. The solvent issue is important and will probably become a key point of concern in the NDI debate. By the way, ABC is currently beginning the peer-review process of an extensive Solvents White Paper to help educate people in industry regarding what solvents are, their roles in the extract manufacturing process, residue limits, etc. 

Gay: In general, the final guidance should incorporate two key elements of DSHEA: 1) ensuring ingredients in the market before DSHEA was enacted are grandfathered in, and 2) clarifying a reasonable process to prove safety for new Ingredients. More than 140 members and others participated in NPA’s NDI education webinar, held just a few days after the draft guidance was released. We have asked our members to give us their feedback so we can include them in our comments to the FDA, and many are contacting the FDA directly to share their concerns. 

Mister: For starters, the NDI guidance should acknowledge that nature identical synthetics are dietary ingredients. The guidance also needs to scale back the definition of an NDI to allow for innovation with respect to older products. Finally, we’re concerned that the Level of evidence described in the draft guidance reads more like a food additive petition.

Dijkstra: InterHealth is aligned with CRN’s opinion, and there are three key things we would like to see amended to be more in line with what’s reasonable for the dietary supplement industry. First, FDA should grandfather ingredients that were in the food supply prior to DSHEA’s enactment. Second, NDIs should be required for “new” ingredients, not for finished products. Third, safety requirements specified in the guidelines are too stringent and safety requirements should be based on reasonable safety evaluation of the dietary supplement ingredient.

Green: FDA must investigate its own cost of implementing what CRN’s Stephen Mister has termed a “giant paper exercise.” FDA’s Daniel Fabricant has already admitted that they currently have only 10 people assigned to NDIs—that’s a logistical nightmare waiting to happen, and could prove disastrous for both the FDA and our industry.

NIE: What are important points for the industry to keep in mind in terms of preserving DSHEA? 

Blumenthal: I think that many people would agree that DSHEA is by no means perfect. However, in principle, ABC tends to agree with those who say that it should be fully and robustly implemented before additional legislation is contemplated. With the current concerns about government spending, it is problematic how much funding FDA will be given to increase its regulation of the dietary supplement industry. Such additional funds, if they are available, should be applied in a most judicious manner—one that keeps the consumer’s interest in mind.

McGuffin: The two most important actions are to maintain our vigilance, so that we are always attentive to the legislative process and furthering Congressional relationships; and to conduct our supplement businesses with a high degree of integrity. It is AHPA’s job to do the first. We rely on our members and the industry at large to take care of the second, though we are always prepared to provide whatever tools and training are needed.

Mister: We have to remember that DSHEA was never intended to be a full pass—and we gave up some things in certain areas, and received some in others. The industry agreed that if we got nutrient claims, we need to keep up with our end of the deal to not have companies out there saying our products “prevent, cure, treat, etc.” This is the deal we made and both sides—FDA And the industry—made promises that we all need to keep. 

Gay: We all know this is a regulated industry, but some policymakers don’t believe that. There is always another bill or regulation or guidance lurking. The industry needs to stay informed, engaged and ready to act. The best way to do that is through NPA or another trade association.

Dijkstra: The industry is better served when it talks with one voice. There needs to be a concentrated effort for the industry groups to come together and form one solid opinion to go back to the FDA, FTC and Congress on important issues. As a research-based ingredient supplier dedicated to making people’s lives healthier, InterHealth shares a similar vision of our advocacy groups. We support the trade organizations to assist them in engaging in politics and policy. 

Kohli: Our industry should be on the lookout for those who are unscrupulous and who would give just cause for criticism and dismissal. We need to police ourselves more strictly and not allow industry members to give us a bad name by cutting corners in quality (not following GMPs), or marketing unscrupulously and/or using unallowable claims. The best way to stop having fingers pointing at us is to clean our house. We can and should get more aggressive about it.

Pontiakos: The industry has not done a good job of framing the amount of jobs, impact to the economy and impact to the voting base we have. Every state has jobs tied to this industry, but we haven’t highlighted to Congressional liaisons our importance to their constituents. We’re importers as well as exporters, and we employ U.S. citizens in agriculture, sales, research and development, you name it. 

Green: Every member of this industry needs to play a role in protecting our businesses against proposed anti-DSHEA legislation by contacting their state or federal legislators and by rallying their customers and other stakeholders to do the same. In addition, the groundswell of support to defeat McCain-Dorgan bill was consumer-driven—not industry driven. We can’t lose sight of the fact that consumer involvement is pivotal in protecting DSHEA.