Dietary Supplement: Current Good Manufacturing Practices and the Impact on Nutraceutical Quality and Business

For many years, both critics and proponents of the dietary supplement industry felt that the U.S. Food and Drug Administration was slow in proposing rulings on quality and manufacturing requirements to legitimize the industry. The FDA published a proposed rule in March 2003 that intended to ensure that manufacturing practices resulted in unadulterated dietary supplements and that dietary supplements are accurately labeled. Until this proposed rule was finalized, dietary supplements complied with food CGMPs, which are primarily concerned with safety and sanitation rather than dietary supplement quality. Finally, in June 2007, the FDA passed the new current good manufacturing practices (CGMPs) for the dietary supplement industry which took effect in June 2008.

To find out how the new rules will affect the dietary supplement industry, Nerac Food Science Analyst Brenda Van Goethem spoke with Mandy Kraynik, the Marketing Director of Enzymatic Therapy Inc., North America’s leading manufacturer and distributor of dietary supplements and natural medicines. Enzymatic Therapy is widely recognized as the industry leader in innovation, quality and product efficacy. Throughout its history, the company has introduced proprietary first-to-market products and groundbreaking technologies. Enzymatic Therapy was the first company to introduce glucosamine sulfate, gingko biloba and many other products into the North American marketplace.

Brenda Van Goethem: What does this final ruling entail and how is the industry implementing it?

Mandy Kraynik: The current good manufacturing practices, or CGMPs, final rule requires that proper controls are in place for dietary supplements so that they are processed in a consistent manner and meet quality standards. The CGMPs apply to all domestic and foreign companies that manufacture, package, label or hold dietary supplements, including those involved with the activities of testing, quality control, packaging and labeling, and distributing them in the U.S. The rule establishes CGMPs for industry-wide uses that are necessary to require that dietary supplements are manufactured consistently as to identity, purity, strength, and composition. This FDA ruling has a staggered three-year phase-in for small businesses, but the final CGMPs rule is effective in June 2008 for large companies. Companies with less than 500 employees have until June 2009 and companies with fewer than 20 employees have until June 2010 to comply with the regulations.

What do the rules require regarding quality control and testing? Were these kinds of procedures lacking in the industry before this ruling?

The final rule on dietary supplement CGMPs require that manufacturers raise their standards, which in turn requires substantial investment in both equipment and qualified people. There are a few critical areas that require special attention:

• Standard Operating Procedures for all aspects of manufacture, from receipt of materials to processing to packaging.
• Specifications defining the identification and testing requirements of all components and products.
• Master Production Records designed to assure consistent manufacture, product identity, strength, quality, and purity.
• Batch Production Records documenting all aspects of each lot manufactured.
• Laboratory Records including written test methods and data from each and every lot.

While these changes are a tremendous step forward for our industry in elevating the quality and consistency of those products made available to consumers, the requirements still fall short of pharmaceutical standards in a few critical areas:

Enzymatic Therapy has been a licensed FDA-registered drug establishment since 1994, and made this investment more than a decade ago to ensure we not only meet, but far exceed the requirements put forth by the newly approved dietary supplement CGMPs. We feel this is a critical investment as research continues to prove the therapeutic benefits of natural alternatives that go beyond simple nutritional supplementation.

The new CGMPs are meant to promote consistent quality standards within the dietary supplement industry, but how do you think they will affect the future business and marketing of the dietary supplement industry?

At Enzymatic Therapy, we have eagerly awaited the FDA’s issuance of the final rule on CGMPs. We recognize that compliance may be a challenge for many manufacturers, some of whom may not be able to bear the cost. However, we are confident that the new CGMPs will weed out low-quality operations, protecting the health and safety of consumers. Enzymatic Therapy continues to set the bar for dietary supplement quality―a standard that many manufacturers will not be able to meet. In the end, it is consumer safety that is at risk and must be protected.

The new rules do offer a unique advantage in marketing. To date, it has been difficult to prove superiority in quality. Everyone claimed high quality based on their own standards, based on the much less stringent food CGMPs. There have been a number of agencies that have taken advantage of the lack of CGMPs in the industry by offering certification through participation in voluntary audit programs that require a fee. Now, with the published ruling, there is an opportunity to clarify requirements and make them more black and white while leveling the playing field by putting all those within the industry under the scrutiny of the FDA.

In the future, do you see the dietary supplement CGMPs tightening to parallel the stricter drug CGMPs? If so, what impact would that have on the both industry and the consumer?

I think paralleling drug CGMPs is still quite a way off in the future for the dietary supplement industry for a number of reasons. The biggest reason is that the greatest cost impact to the industry would be the incorporation of the three key areas that were actually left out of the ruling as written: testing every lot, stability testing, and bioavailability testing all of which would require a significant investment in equipment and skilled professionals. These issues were hotly debated as the ruling was developed, and I believe stricter standards would be a huge barrier to entry for many wanting to enter this industry, let alone remain in business. It is a double-edged sword, really. The history of this industry is built upon the ability to bring forth natural medicines that have been used for centuries, oftentimes with little to no science supporting the benefits of the ingredient, let alone the key actives providing that benefit.

Standardization of herbs as first introduced by Enzymatic Therapy was a huge leap forward in bringing consistency and quality to the industry, but going the next step to verify bioavailability is a much more difficult task. Often times it is a synergistic effect of multiple actives within an herb that would require the level of investment that pharmaceutical companies put forth in developing new drugs, and we have seen the impact this has had on the cost and availability of prescription drugs.

So, on the one hand, this parallel may in fact slow the introduction of truly beneficial supplements to consumers. And in a time of high healthcare costs and increasingly declining health due to poor lifestyles, it would seem counterintuitive to slow this introduction of potentially beneficial and life-changing solutions. On the other hand, these natural medicines can elicit powerful effects that need to be monitored in terms of the appropriate dosage as well as managing any potential toxic compounds that may also be found in the herbal preparation. The additional quality checks required for drug CGMPs ensures not only that those consumers are getting consistent product in every bottle, but it also ensures that every bottle is providing the active being claimed to provide benefit from the time of manufacture until a specific date of expiration, not currently required by the new dietary supplement CGMPs.

In the end it comes down to what consumers want. Ultimately, they will choose with their dollars. A product either works or it doesn’t, and that is the most powerful regulation that can be put on our industry. Our investment in being drug-compliant does warrant a higher price. However, those who purchase our products are loyal and are strong advocates, knowing they can trust what works every time. And those who are serious about their health are willing to make an investment in a company that is willing to make that same investment.