Industry Speaks on Quality Control

The issue of quality control (QC) continues to garner a lot of attention within the dietary supplement industry, especially under the government's and media's watchful eyes. However, many companies are taking the initiative to provide quality products through third parties such as a QC lab or by a program such as the National Nutritional Food Association's (NNFA) Good Manufacturing Practices (GMPs) program. Many industry professionals believe that self-regulation practices are a step in the right direction, while others testify that a unified industry and more conscientious manufacturing are needed to cast a more positive light on dietary supplements. Natural Products Industry Insider spoke with several industry insiders regarding their thoughts on these issues, as well as their opinions on current quality control efforts, government integration vs. self-regulation and future QC regulation.

Participants from the worlds of manufacturing, trade associations and consulting firms offered their input on this increasingly important issue:

-- Richard Cummings, sales and training director at
Kroeger Herb Products;

-- Gary Jepson, president of Pharmore Ingredients and former vice president of strategic sourcing for Weider Nutrition;

-- Jim Lassiter, the principal of the Lassiter Group;

-- Warren Majerus, vice president of quality and technology at Pharmore Ingredients;

-- Max Motyka, director of the human products division
at Albion Labs;

-- Karl Riedel, chief executive officer of Nature's Life and a board
member of NNFA; and

-- Tony Young, legal counsel for the American Herbal Products Association (AHPA).

Q: In your opinion, what is the state of quality control in the dietary supplement industry?

Motyka: Some QC efforts are good for as far as they go. Many supplement companies have gone through the expense of upgrading their QC lab equipment or placing in-process controls as evidence of their ability to have proper GMPs. However, I must say that this effort needs to go beyond 'window dressing.' I think that the ethics of the industry need addressing more than GMPs and quality control issues. In some cases, companies have received the stamp of the NNFA's GMP program and claim that this assures consumers that they can be trusted, when, in fact, it does not. Instead, they use this as a license to continue their program of consumer deceit.

Lassiter: The current industry efforts in QC lack two critical elements: the first is coordination and the second is establishment of universal standards. On the first point, we have multiple trade associations representing us but a general lack of interest in attempting to come together as a single industry to affect change. In order to have a strong future, all constituents and associations need to work together to provide solid support behind one initiative on each topic of concern, whether that's quality standards, public relations or government action. Secondly, establishing universal standards is the first real step in implementing test methods to evaluate materials and have one set of standards for each material. Without these standards, there is no opportunity for accurate evaluation. This again must be supported by the entire industry.

Q: How can companies overcome consumer lack of confidence? How do claims fit into this?

Majerus: The consumer is becoming more aware and cautious about claims made on product efficacy and labeled potencies. Eventually, those companies not complying with the rules will be discovered and weeded out. Until that happens, the whole industry will continue to suffer the consequences of consumer lack of confidence. Eventually, there will be fewer players in the industry supplying certifiable products. Successful dietary supplement manufacturers are already policing themselves by requiring raw material suppliers to supply certified ingredients and that the formulas for finished product are thoroughly tested to meet labeled claims.

Riedel: Most suppliers and retailers do not devote enough time or effort to their respective jobs as gatekeepers. Our industry grew primarily because consumers perceived us as offering a higher valued product compared to conventional products.

We have always has product quality concerns, but since DSHEA, consumers expectations have risen exponentially as manufacturers have trumpeted an overabundance of health claims for dietary supplements. Because of ineffective formulations and/or non-existent GMPs, many products do not deliver on their claims, thereby abusing the products' implied health benefit. This violation of a basic business tenant--only promise what you can deliver--has resulted in erosion of consumer confidence, fueled by a voracious and adversarial press.

Q: Is there a balance between industry self-regulation and government regulation?

Young: There is no balance. There is no government regulation. The government hasn't acted on the industry-proposed GMPs provided to them within one year of DSHEA's passage [which occurred in 1994]. Presently, there is very little government enforcement or regulation of dietary supplements. As for self-regulation, some of it is work and some of it is not. For example, the industry has a good program for self-regulation among ephedra product manufacturers; a relatively good program for monitoring botanical manufacturers; and relatively good self-regulation for not adding drug ingredients to dietary supplement products.

Riedel: The industry is definitely taking the lead due to the presence of erratic government enforcement of existing laws and regulations. The FDA has been ineffective in implementing the most important aspects of DSHEA such as finalizing GMPs and enforcing against dietary supplements that are labeled with untruthful or misleading claims. Industry has taken the lead in this arena by submitting GMPs to FDA, by registering all members' dietary supplements [NNFA], and by continuing to update and disseminate individual ingredient and product standards.

Lassiter: The present efforts at industry regulation fall short. From the government side, there has been little to no enforcement activity of the existing regulations. This lack of action on both parties' parts supports the mainstream media's contention that this industry is NOT regulated. The role of industry in self-regulation must also include actions against those organizations that are not meeting industry standards.

Jepson: I firmly believe that the industry must not wait for government intervention on this matter. Major producers of dietary supplements must step up to the table and cooperate together with the major health food and retail buyers, while and the raw material suppliers need to develop reliable and accurate methods and standards for measuring an ingredient's active compounds.

Q: How are organizations and certifying boards helping quality control efforts?

Riedel: Industry trade associations are making significant efforts to enhance overall product quality and improve consumer confidence. The efforts of NNFA's independently certified GMP program is an outstanding example, as well as the efforts of the American Herbal Pharmacopeia (AHP) to develop a pharmacopeia. However, all of these efforts need greater participation and support by all industry players.

Young: NNFA has launched a program of GMO compliance audits, at the urging of its retail members, which has the potential for great success if NNFA members and other utilize this service. Other organizations are pursuing efforts to implement analytical testing services, which is a more complex issue. Only time will tell if any of these organizations can come up with a program that can meet the needs of an industry that doesn't manufacture pharmaceuticals.

Motyka: The efforts of the NNFA alone are never going to get the job done. It is very difficult, if not impossible, for this type of trade association to be effective in this way. The CRN has brought to light a couple of alternative groups that can serve as independent certifying boards for dietary supplements. This may be the best way to go. As for government regulation, we can already see that it is over-taxed in this area, lacking the time and maybe even the interest to do the job right.

Q: What is the ideal role for the industry and the government in effective or proper regulation?

Motyka: Until we do something as an industry that makes it absolutely unacceptable to market products that are mislabeled, I am not sure what can be done. Until we stop looking the other way when companies are claiming ingredients and quantities on their labels that aren't there, we will never fully implement effective regulation.

Majerus: The ideal would be to have the government establish minimum standards based on industry input, just like the manner in which the food industry currently operates. Once regulations establish a minimum level of performance, the marketplace will reward the best companies and eliminate those that do not strive to meet higher than minimum standards. The end result will be an industry that has higher standards than if the government stepped in and tried to mandate rules without industry involvement.

Over-regulation could put many legitimate companies out of business, because they will not be able to afford excessive--and perhaps arbitrary and unnecessary--testing, validations and cGMP requirements. Minimal regulation is the best approach.

Jepson: I would limit government interaction to being an auditor for each manufacturer and limit the scope of the audit to cGMP-related issues and GLPs (Good Laboratory Practices), with an eye on proper methodology usage and compliance.

Of course, the area of claims and product activity needs to be monitored more closely. Testing based on industry-developed standards should then be randomly conducted by the government or an industry watchdog group to assure compliance for active compounds shown on the label. Those meeting the label claims, within plus-or-minus tolerances, should be listed for consumers and retail buyers free of charge.

Young: Ideally, manufacturers would see that it's in their best interest to manufacture products without illegal claims and that deliver the amount of the ingredient in the finished dosage form that is on the label. This would allow for less government enforcement. Once you have government enforcement, more manufacturers will realize it is in their best interests to do things right from the beginning. Presently, there is no government enforcement to speak of, and therefore it is very difficult for manufacturers in this industry to understand why it is important to observe the law. I think that if the industry expects the franchise to prosper, it has to be able to convince consumers that the products deliver the ingredients they claim to have. Therefore, self-regulatory programs, where these kinds of things are assessed by third parties, are important.

Q: Can the industry and the government work together?

Majerus: Yes, if the government requests industry input on dietary supplement requirements, and as a joint effort, establishes minimum guidelines to assure safety and potency. Both could monitor the initial guidelines to determine if more or less involvement is required and adjust accordingly.

Riedel: The primary obstacle to overcome before such an ideal picture becomes a reality is apathy. ALL industry participants must become aware of, and committed to, making quality products--as well as the systems that contribute to ensure they are.

Cummings: I still think the industry should be more self-regulated than government-regulated, because that is basically what a democratic government is designed to do. Part of it has to do with giving people the choice and the freedom to choose alternative health care. For instance, when the government tries to limit the industry, I think people should take a lot more responsibility for themselves and their health rather than depending on what the government is trying to do. For people to have true health freedom, they need to have a choice of health-care options.

Young: If the public relations campaigns aren't backed up by substance, they aren't worth anything. We have to have programs whereby quality is enforced, even if it is within the self-regulatory context. In the interim, manufacturers need to bring products up to compliance. No manufacturer in this industry should be setting itself up to have its products analyzed by a television station or by ConsumerLab or by anyone else and have it turn out that they don't deliver the amount of ingredient that's on the label. Only individual manufacturers can fix that problem. Trade associations or anybody else can't fix it. At some point, the manufacturers' excuses for turning out non-quality products run out.