Pain is unfortunately a part of daily life for several consumers, mostly manifesting itself in the form of migraine headaches, joint pain and low back pain. In its many forms, pain is often debilitating and results in lost wages and quality of life. In addition, pain costs the American public several billion dollars a year.

The National Pain Foundation, Englewood, CO, says that 40 million Americans suffer from arthritis, another 45 million suffer from headaches (migraines included) and that at any given time, 1% of the U.S. population is temporarily disabled by back pain.

Indication Areas

Several pain relieving (analgesics) and anti-inflammatory products are designed to inhibit the production of chemicals that cause pain. Often discussed are the prostaglandins, which is the group of chemicals targeted by nonsteriodal anti-inflammatory (NSAIDS) drugs like aspirin and ibuprofen. In recent years NSAIDS have fallen out of favor with the medical community due to the prevalence of side effects. In addition, according to Nature's Pain Killers by Carl Germano and William Cabot, "These pain relievers inhibit a key enzyme in prostaglandin synthesis. The enzyme is cyclooxygenase, or 'Cox,' for short. In 1990, another key discovery revealed that two Cox enzymes exist, so scientists named them Cox-1 and Cox-2. Although researchers developed NSAIDS in the 1970s, until just recently, all available NSAIDS inhibited both Cox-1 and Cox-2. They control pain by inhibiting Cox-2, and therefore, inflammation, which is their beneficial action. However, these NSAIDS also inhibit Cox-1, which means that we stop making the good prostaglandins that protect the stomach's lining and help blood to clot." Due to these recent findings many drug companies started developing products that targeted only the Cox-2 enzyme.

Inflammation plays a key role in pain management. Nature's Pain Killers indicates that inflammation serves a distinct purpose: It protects us. "It helps the body dispose of toxins, bacteria and any other foreign material at the site of the injury, which prevents their spread to our other organ systems. In addition, inflammation helps prepare the site of injury (or repetitive trauma) for repair. Pain is the red flag that tells us we have an injury and inflammation."

Jeremy Appleton, ND, director of scientific affairs, Cardinal Nutrition, Vancouver, WA, makers of OptiMSM, discussed some of the sought after indication areas for pain. "The areas sought after for pain management are vast and overlapping," he said. "These include headache and migraines; osteoarthritis and joint pain, especially in the aging baby boomers; sports recovery and minor injuries; low back pain; spinal subluxations and misalignments, for which one would go to a chiropractor; cancer pain; diabetes, which is sometimes associated with certain neuropathies that can be very debilitating; Crohn's disease; shingles; endometriosis and PMS."

It is understandable that consumers when experiencing pain want immediate relief. While that is a reality of OTC and prescription drug medications, supplements may not resolve pain issues with the same urgency. Deanne Dolnick, national education manager, Soft Gel Technologies, Inc., Los Angeles, CA, (suppliers of PharmaFew, a potent form of feverfew) offered her opinion on this issue. "We live in a society of the quick fix. If somebody is in pain, they want to take something immediately to alleviate that pain. Many foods have been shown to change the body's internal environment for those who suffer from arthritis or headaches, but often times consuming the right foods will not give immediate results," she said. "Those who need to change their diets to help them manage their pain, need to think about this for the long haul."

In light of the fact that most supplements cannot provide immediate pain relief, it is important to realize that in most cases they may serve a different but beneficial purpose. "People that start taking glucosamine, for example, may not receive immediate relief of pain, rather it takes six to eight weeks to see the benefits symptomatically," said Tom Fox, director of marketing, Emerging Products, Cargill Acidulants Division, Naperville, IL, (suppliers glucosamine hydrochloride under the trade name Regenasure, which does not use shellfish as its source). "I think typically when people think of pain they want to take an analgesic to suppress or alleviate the pain. With a product such as Regenasure, the clinical evidence supports that it attacks or alleviates the source of the pain, whether it be osteoarthritis or chronic joint pain." He continued, "It is easy to take an analgesic to suppress the pain that a consumer feels but with a product such as glucosamine there is evidence that it actually goes to the source of the pain."

Janice Brenner, product development scientist, Bioriginal Food & Science Corp., Saskatoon, Saskatchewan, Canada, (suppliers of essential fatty acids-EFAs-from a variety of sources) said pain management continues to focus on improving the underlying conditions related to pain. "In the case of arthritis and joint pain, reducing the inflammation by supplementation with natural anti-inflammatory agents, such as EFAs, is popular," she said. "In addition, there is evidence that EFAs may play a preventive role in decreasing cartilage destruction and modifying inflammatory and immune processes that cause inflammation, pain and other symptoms of joint damage. Natural agents that both prevent further destruction and alleviate pain and inflammation are in demand."

Also commenting on EFAs was Karen Todd, senior marketing manager, New Ingredients & Business Development, DSM Nutritional Products, Inc., Parsippany, NJ, (suppliers of a range of PUFAs, including omega 3 and omega 6 products under the ROPUFA brand name). "PUFAs have been helpful in relieving symptoms of rheumatoid arthritis. A meta-analysis of 10 clinical studies reported a significant, moderate improvement in tender joint count and morning stiffness in patients consuming fish oil for three months," she said. "The clinical interventions using GLA-containing oils were less consistent, but three of six studies demonstrated a moderate to strong relief of pain and tender joint count and a small reduction in joint stiffness in patients consuming borage oil or black currant seed oil for six months."

Sonya Cropper, director of operations and communications, Geni Herbs, Noblesville, IN, (producers of Boswellia serrata under the trade name WokVel) shared her views on the role of inflammation from a botanical standpoint. She said that botanicals that offer inflammation relief are increasingly being studied to determine their mechanism of action. "Understanding the pathways of inflammation and the mechanism of action of ingredients in various diseases has made research critical to formulate effective products," she explained. "WokVel, for example, has been studied in great depth to find that it is a potent 5-lipoxygenase inhibitor, making it unique and effective in the treatment for osteoarthritis, as well as other forms of arthritis."

Market Potential

The pain relief market is anything but small. In fact, it is one of three areas targeted by most large OTC and prescription drug manufacturers-the others being cough/cold/flu and gastrointestinal. Although pain management is dominated by these large firms, dietary supplements have an unprecedented opportunity to step into the spotlight and take their share of the market. Given the vast impact of pain on consumers and the issues posed by OTC and prescription pain (and anti-inflammatory) medications, dietary supplements certainly have a role to play.

Volker Gallichio, U.S. general manager of Weber & Weber International GmbH & Co. KG, Miami, FL, (a German nutraceutical manufacturing company that manufactures Petadolex, which is a patented composition of the active components in butterbur extract), placed the total market for pain management products at $7.3 billion. Breaking the market down, he said, prescription pain medications make up 63% of the market ($4.5 billion); OTC products comprise 36% of the market (nearly $3 billion) and supplements make up for the remaining 1% of the market ($75 million)-not counting joint supplements, such as glucosamine, MSM and SAM-e.

Cardinal Nutrition's Mr. Appleton offered his perspective on the opportunities. "I would call this market staggeringly huge and it is only going to get bigger as the aging baby boomers settle into the aches and pains of old age," he said. "All you have to do is consider the numbers of consumers that keep Tylenol, aspirin or ibuprofen in their medicine cabinets to realize how big this market is and where the incredible potential lies."

Mr. Appleton said the question is whether or not there exist natural therapies that are effective. "Most natural therapies are not going to work fast like a magic bullet. As a result, the benefits for the natural segment lie in the fact that these products may have fewer side effects and possess additional benefits," he said. "Take MSM, for example. MSM is an ingredient that is an analgesic and an anti-inflammatory, but it also could be modifying joint structure as well. Similar things could also be said for glucosamine and chondroitin. The point is that these ingredients in addition to possessing pain relief capabilities have the potential to offer other benefits. This is in contrast to traditional pain relievers, such as ibuprofen, which only have analgesic and anti-inflammatory properties (Tylenol is only an analgesic).

Label Claims

What is likely holding back the explosion of products in the area of pain management is the sticky situation of label claims. Curt Hendrix, chief science officer, PR Osteo LLC, Thousand Oaks, CA, (producers of MigreLief, which combines feverfew, riboflavin and magnesium) discussed the limitations and expressed concern. "Due to existing laws, especially as they relate to the ability to make claims to reduce pain, very few, if any, companies can actually put on their labels that a product reduces pain because it is considered a drug claim," he said. "This is unfortunate because even when some of these ingredients show in well-structured clinical trials that they may reduce pain they are not allowed to make the claims and I feel that deprives the public of information that they should be able to access."

Also discussing labeling issues was Cardinal Nutrition's Mr. Appleton. "Pain is largely considered a pathological phenomenon, so it often does not fall within the confines of a legitimate structure/function claim. 'Reduces Joint Pain' and 'Relieves Headache' are OTC monograph claims, not structure/function claims. In fact, the FDA has written courtesy letters to manufacturers who have made label claims for 'Supporting normal, pain-free movement,' for example," he said. "In the current regulatory environment, which some would say is inhospitable, if not hostile, to the supplement industry, I expect the communications from FDA on this subject are going to be less than courteous in the future."

Going into further detail, Mr. Appleton explained that a statement would be considered a disease claim if it explicitly or implicitly claimed an effect on one or more signs or symptoms that are recognizable to healthcare professionals or consumers as being characteristic of a specific disease or of a number of diseases. "This leaves some wiggle room," he said. "FDA has said that some minor pain relief claims may be appropriate structure/function claims for dietary supplements. A claim that a product is intended to treat minor pain, without reference of any other conditions, symptoms or parts of the body that would imply disease treatment or prevention, would be an appropriate structure/function claim. This is because minor pain, by itself, can be caused by a variety of conditions, not all of them disease-related."

Also finding some bright spots within current labeling regulations was Brent Rogers, product applications specialist, Cargill Acidulants Division, Eddyville, IA. "It is our understanding that FDA's new criteria for qualified health claims is still very new and companies are evaluating that," he said, adding, "We are not certain what the opportunities are yet with the qualified health claims initiative but it may open the door for more opportunity in this area in the future."

Weber & Weber International's Mr. Gallichio offered another solution. "We find it especially promising that the FTC has eased its position on disseminating clinical evidence. The only catch is you can only use clinically supportive evidence when marketing the actual product used in the clinical trial," he said. "Another possibility for label claims is to apply for an OTC claim under the FDA's Guidance Level One approval process for dietary supplements. Applicants, however, must meet stringent criteria related to clinical efficacy, safety and standard operating procedures (SOPs) for adverse event monitoring."

For the Future

There is no question that navigating this market in the future will be difficult. However, there are opportunities to steal market share for those companies that can find the right formula for the indication area they are targeting and create a message around it that is both meaningful to consumers and not misleading. Those companies that are not willing to play by the rules will be the ultimate losers. Cardinal Nutrition's Mr. Appleton warned, "Know and obey the law, so that you are not surprised when FDA comes knocking on your door. Also, make responsible structure/function claims based on science and understand that most supplements are not going to work at the speed of some of the traditional pain relievers and medications already out there."

Tim Bauer, director of sales, Cargill Acidulants Division, Naperville, IL, discussed the future role of glucosamine in the aging baby boomer market. "You will see continual positive growth for glucosamine products and we believe that you will see people marry functional ingredients with functional foods and beverages," he offered. "We believe there is a healthy market on both sides of the table in that there is a growing population that remains extremely active and that want to remain active well beyond what the last generation wanted to accomplish. That said, it is our goal to help consumers move forward and continue to be active and comfortable."

PR Osteo's Mr. Hendrix said the future of pain management lies with physicians. "Our healthcare comes from the physicians we deal with and this is where information should come from in a perfect world," he said. "For those products that do have the science it is important that it be put into the hands of doctors, so they can merge it with everything they know about pharmaceutical medicine and other medical options. This way, patients are exposed to the totality of products available to them as opposed to getting some of their options from a health food store clerk. It ultimately comes down to doctors knowing about all of the options, not just the pharmaceutical ones." NW