Enzymes, Breaking it Down

In the dietary supplement industry, enzymes are primarily used as digestive aids, according to SPINS market research data, and sales are on a three-year upward trend, with percentage growth rates much greater than those in the overall supplements segment. In fact, in a 52-week period ending in August 2006, cross-channel digestive aids and enzymes sales totaled $355 million, an increase of 16 percent over the prior year, with most sales growth generated in natural supermarkets and drug stores.

Growing consumer interest in digestive aids and enzymes also offers various interesting growth opportunities across channels, departments and categories; with broad product development and strong sales, enzymes have proven to be one of the more dynamic and promising products in the food and supplement industries.

Aside from relief from gas, bloating and constipation, a growing number of consumers are choosing to take enzymes on a regular basis, not only to maintain digestive health but to maximize their nutrient intake, said Roger Rohde Jr., president of Triarco Industries Inc. Enzymes allow individuals to properly break down their food and more efficiently absorb vitamins, minerals and amino acids, he said.

Tony Reinsch, territory manager for American Laboratories Inc., agreed: American eating habits and fast-paced lifestyle have prompted this industry to become a rapidly developing market for the diverse use of enzymes, especially for a growing number of people who are lactose intolerant.

Unfortunately, as we age, the bodys ability to produce enzymes becomes less effective. The Boomer generation has become an increasingly important segment of the enzyme market, Rohde said. But he also pointed out the market is not limited to seniors. Consumers of all ages are reaching for product formats that incorporate convenience with novelty along with their enzymes such as chewables, wafers and beverages, he said.

Troy Aupperle, president, Enzyme Research Center (ERC), said its U.S. business consists mostly of contract manufacturers who purchase enzymes for both digestive and systemic (anti-inflammatory) uses. But he believes in enzymes potential for growth and variety in the United States. Most American consumers have not been educated sufficiently to be able to fully appreciate the vast range of benefits that enzymes have to offer, Aupperle said.

The Chemical Mediators

Enzyme use goes well beyond dissolving digestive dilemmas. Nena Dockery, M.S., National Enzyme Co., noted within the dietary supplement industry, isolation of new enzymatic activities from natural, non-genetically modified sources has led to new opportunities for their use. More is being researched in the area of systemic functioning of orally administered enzymes, she said. The recently discovered fact that low-grade inflammation may be indirectly related to a large number of chronic disease conditions has uncovered a large area of future enzyme development.

Mike Smith, sales and marketing manager at Specialty Enzymes, said the two common areas for systemic enzyme use are as an anti-inflammatory and fibrinolytic.

Serratiopeptidase and nattokinase are two newer enzymes that possess both properties, he said, and it is likely that research will yield more of these novel enzymes with systemic applications as interest and understanding continue to advance. For example, ERC created one systemic blend utilizing enzymes (along with 14 different strains of probiotic bacteria) to create its Nightly Essense product.

Rohde cited the example of how athletes can benefit from the proteases in Triarcos Aminogen® that act on inflammation, speeding up tissue repair and muscle recovery. The same enzymes that promote muscle recovery may also play a role in other health issues. Oral enzyme therapy has shown promise as an anti-inflammatory agent in osteoarthritis, irritable bowel disease (IBD), celiac disease and even conditions such as asthma and soft tissue damage, he said.

Size aside, enzymes are no small players. The list of possible conditions they could affect continues as they may also assist with gluten intolerance, noted Jim Titus, director of international sales and marketing, Deerland Enzymes. While enzymes for autism have made great strides over the last number of years, there is some information coming out indicating enzymes (as AN-PEP) have application for Celiac Disease as well, he said With applications in nutritional formulas, tablets, capsules and blends, Panc-Zyme (American Laboratories Inc.) has many naturally occurring enzymes; but, it specifically contains trypsin and chymotrypsin protease, amylase and lipase, and can be used in formulations to hydrolyze proteins in milk, meat and cheeses.

Enzymes even find a function in personal care and the emerging spa industry; Aupperle noted enzymes used for topicals (body and face peels, hair treatments, etc.) will continue to increase as new products are being marketed to baby boomers. Rohde also sees enzymes' growing potential in the health and beauty market.

"Protease enzymes may also contribute significantly to cosmeceutical product development, he said. Skin care treatments for a range of applications from wound healing and eczema to exfoliation and skin regeneration, may be possible with these enzymes."

Delivering the Goods

Ensuring proper delivery and timing of enzyme release during digestion is a primary challenge in enzyme application. The stomach and intestine offer little to no hospitality to these fragile, protein-based catalysts, and enzymes need to reach just the right destination in the body to work their magic. These proteins are very easily affected by heat, pH and heavy metal ions; but, through methods similar to enteric coating, manufacturers have developed capsules that allow the contents to survive the trek through the digestive tract and release in the small intestine. The coatings prevent early release of the enzyme and may solve some problems for certain enzyme functions, while other functions require further research to develop new modes of accessibility.

But overall delivery systems have not changed much, as Titus explained. From what I have seen globally, the delivery systems have remained constant, due to enzymes nature, he said. Putting them into liquids activates them, and heat denatures them, so that limits the delivery system for digestive enzymes. Currently they are available as powders, liquids, tablets and [hard] capsules.

And although the enteric coating is popular, some disagree with its use. In most applications it is unnecessary and may even have harmful excipients, Titus said. Smith noted: Some enzymes may work better with an enteric coating, but the important issue is: What is the activity of the enzymes? And how can you keep its activity as stable as possible for as long as possible?

There are several new delivery system technologies on the horizon, but are not practical for use within the dietary supplement industry because of cost constraints, Dockery said, citing nanotechnology-based systems as an example. Another technology being utilized to a limited extent for delivery of supplements containing enzymes involves specialized liquid media within a softgel type capsule or liquid product. However, Dockery cautioned, The enzymes must be protected in some way from being activated by the liquid, either by coating the enzyme or by manipulating the structure of the liquid itself to prevent interaction with the enzymes.

Choosing a Supplier

Price and availability are always concerns when considering where to buy raw materials, but neither of these criteria should be paramount in choosing an enzyme supplier. Receiving a consistently high quality product is key to maintaining a positive long term supplier/customer relationship. And the quality of that product will depend on the quality standards of the actual manufacturer; this is where the customers technical savvy is important in finding that quality and consistency from a supplier.

In our ever-changing regulatory environment, it is critical to have a supplier that has adequate technical information on their products and is open in sharing that information. [With] pesticides, aflatoxins, allergens, nutritional information ... the list goes on and on, said Jo Ann Peterson, director of quality assurance, National Enzyme Co. Basic information such as available testing methods for identity should be exchanged between the supplier and customer, she said. It is important for a supplier to understand the unique needs of each customer as specifications need to be determined and supported by the supplier.

Rohde noted it is important to choose a supplier with enough experience to help navigate the intricacies of enzyme use. One indicator of a suppliers expertise is whether they offer patented formulas, because developing these requires an enormous amount of time, resources and a thorough understanding of enzymes, he said.

And confirm the suppliers enzymes are measured and sold in Food Chemical Codex (FCC) Units, and that the proper FCC units are applied to the corresponding enzyme. Using an unusual or inappropriate bioassay can skew results, so find out what type of assay method was used, when and by whom it was conducted. Enzyme assays are unique in that they serve not only to identify but verify activity; further, any clinical testing done by suppliers also demonstrates that their product works.

Unlike vitamins, enzymes cannot be measured simply by quantity or weight, but by potency; this is done by assaying the quantity of hydrolysis that occurs under specific conditions. When looking at enzymes and their activity levels a consumer should follow the label and make sure they understand what unit of potencies the product is in (i.e. grams or milligrams), Reinsch said. The label should then give you information such as; each tablet contains or each 30 mg contains He added the basics such as the common name of the enzyme or the specific commonly known potency per gram or milligram is also important.

An in-house lab that is set up for testing enzymes is another factor to consider when choosing a supplier. Titus said: The activity of a product must match its label and be able to be supplied to the market consistently from lot to lot. Only suppliers with in-house labs [are] set up to not only test enzymes when they arrive at a facility but also at key points in the tableting/encapsulating and packaging [process], and then again before leaving the facility.

Overall, developing a relationship with the owner and knowing who you are working with is a fundamental aspect of finding a supplier. Aupperle noted: The entire organization is a reflection of this person youre working with. Do you have the same business principles and philosophies? Any enzyme supplier who knows their product works will stand behind their product and want to demonstrate that to the customer.