Compliance Column

Advertising - operation big fat lie

While there are some restrictions on what information and claims can be included on labels, and many reputable supplement manufacturers who abide by the rules, Federal Trade Commission (FTC) officials have described a proliferation of unfounded and exaggerated claims for food supplements. This is especially true in the area of weight loss. Not surprising when you consider that the global obesity market has an estimated market potential of $3.7 billion by 2008. We have all seen the ads for products that "eliminate cravings", "control appetite" and let you “eat what you like and lose weight”. To help counter this, the FTC has launched a campaign to help consumers’ spot claims that almost always signal a diet rip-off. Weighing the Evidence in Diet Ads warns consumers to steer clear of diet pills, patches, creams, or other products that offer quick weight loss without diet or exercise; that claim to block the absorption of fat, calories, or carbohydrates; or that promise that consumers can eat all they want of high-calorie foods and still lose weight.

In an innovative approach the FTC has also launched a new "teaser" web site to reach consumers surfing online for weight-loss products and it’s certainly worth a look. At first glance, the site appears to advertise a new pill promising to help consumers “Lose up to 10 pounds per week - with no sweat, no starvation!” When consumers try to purchase the product, they learn that the ad is actually a consumer education piece posted to warn consumers about diet rip-offs.

Natural VIOXX alternative

Arthritis is another area that has been targeted by the food supplement industry and it’s an area that’s worth an estimated $2 billion a year. Many individuals will swear by natural products to relieve their symptoms. Food supplements such as simple honey and vinegar mixtures, mussel extract, desiccated liver pills, shark cartilage and CMO (cetylmyristoleate) all have their supporters.

With the public loss of confidence in the FDA’s ability to protect the consumer that resulted from recent controversies over the COX-2 inhibitor VIOXX, many more arthritis sufferers are looking to food supplements to treat their condition. Purveyors of so-called natural remedies have quickly stepped in to fill the void resulting from the VIOXX withdrawal. A plethora of products is now available that claim to be natural anti-inflammatory and COX-2 inhibitors. These products are marketed as “non-prescription, organic, all natural COX-2 inhibitors”. One such product contains green tea, turmeric and ginger in addition to holy basil, rosemary, oregano, scutellaria, Chinese goldthread and barberry. While the manufacturers claim to have “extensively researched the herbal pharmacopoeia and international medical databases and discovered that the following time-tested herbs, properly extracted and blended in the correct proportions, contain at least eight phytonutrients that may safely and significantly support a healthy inflammation response” they stay within the law by use of a disclaimer that states that the product is not intended to "diagnose, treat, cure or prevent any disease". The distinction to the consumer may not always be apparent - especially when the alternatives are limited.

Many people take dietary supplements based on word-of-mouth recommendations and assume that every bottle of product X will be as safe an effective as the next, irrespective of manufacturer, supplier or storage conditions. Oftentimes, the reality is very different.

But they’re natural so they’re safe!

While it may seem reassuring to treat medical conditions with naturally occurring food supplements, often the supplements for sale are not as natural as you might think. Rather than being extracted from a natural organic source, economic pressures mean that most commercially available vitamins are chemically synthesized. The synthesized form seldom matches exactly what nature formulates. Synthetic vitamins often have a molecular structure which is the mirror image of the natural vitamin it is trying to replicate. So it may not be accepted by the cells in the way a natural vitamin is, rendering it useless or potentially harmful. Additionally the synthetic product does not contain the traces of natural catalysts which are often essential to the effectiveness of the substance.

Even when a product is extracted from natural sources, traces of the solvents used in the extraction process are difficult to eliminate and currently no standards exists for what is an "acceptable" residue level, and no checks are made by FDA or independent laboratories.

But the label says it’s safe!

The purity of food supplements also presents a problem with great variation between manufacturers. In the area of sports medicine, doctors are increasingly finding that supplements labeled as being “safe for use by athletes” are in fact contaminated with prohibited substances such as nandrolone and testosterone as well as their precursor compounds. When one batch is tested and found to be free of steroid compounds or stimulants, another may indeed be contaminated. There have also been reports that some tablets from a single bottle are contaminated with steroids while others from the same bottle are "clean."

This is of great concern because many consumers use these products without consulting a health care professional and are often reluctant to discuss the use of these products even after a problem occurs. There is an additional danger for professional athletes, namely that the dietary supplements they take might cause them to fail a doping test.

Want some ephedra? Have a cup of tea!

Under the provisions of DSHEA, it is the manufacturer who is responsible for ensuring that its dietary supplement products are safe before they are marketed. Unlike drug products, manufacturers and distributors of dietary supplements are not currently required by law to record, investigate or forward to FDA any reports they receive of injuries or illnesses that may be related to the use of their products. Once the product is marketed, FDA has the responsibility for showing that a dietary supplement is "unsafe," before it can take action to restrict the product's use or removal from the marketplace. Unfortunately, last year, the FDA had to take just such action.

Dietary supplements containing ephedrine alkaloids (ephedrine and pseudoephedrine) had been extensively promoted for aiding weight control and boosting sports performance and energy. This situation with ephedra illustrates the confusing regulatory status of dietary supplements. When chemically synthesized, ephedrine and pseudoephedrine are regulated by the FDA as drugs, whereas dietary supplements that contain ephedra, also called ma huang escaped such regulation. Following extensive investigation, the FDA determined that ephedra presented an unreasonable risk of illness or injury being linked to significant adverse health effects, including heart attack and stroke. On April 12, 2004, a final rule went into effect prohibiting the sale of dietary supplements containing ephedrine alkaloids (ephedra). However, to confuse matters further the scope of the rule does not pertain to traditional Chinese herbal remedies and doesn't apply to products like herbal teas that are regulated as conventional foods.

Not everyone was happy with the FDA ruling, claiming that the real problem was that the FDA did not mandate proper labeling of ephedra, such as per-dose and per-day limits, contraindications and appropriate usage and that they did not enforce the law to ensure that ephedra products were not spiked with chemical ephedrine, which makes a food supplement adulterated and illegal.

Federally funded supplements

In 1992, the National Institutes of Health (NIH) created an Office of Alternative Medicine and allocated initial funding of $2 million. This year, the now-named National Center for Complementary and Alternative Medicine has a budget of $120 million to study what works and what doesn't. NCCAM is supporting several clinical trials to test whether botanicals hold up to their claims. Other researchers are developing techniques to assess quality and consistency, whilst others are investigating the power of dietary supplements to fight off specific diseases. Clearly alternative medicine is going mainstream! With soaring consumer demand for food supplements, there is an economic advantage for the pharmaceutical and medical community to provide safe and effective products to the consumer. The industry should also feel an obligation to use the expertise and knowledge of scientific inquiry that it has developed (such as unbiased randomized and placebo-controlled studies) to separate the fact from the fantasy.

Safer than drugs

Advocates of dietary supplements will tell you that they are much safer than FDA approved drugs and perhaps they are right. Estimates of individuals that die from prescription drugs are over 100,000 every year, whereas since 1993, there are just over 100 deaths linked to food supplement use. But the truth is we really don’t know. Extensive testing of prescription drugs provides a detailed risk profile but systematic research has never been done for dietary supplements. Interactions between prescription drugs and supplements also needs to be investigated. What we do know is that the public want to be in control of their health care decisions and many are looking for alternatives to what is being provided by the pharmaceutical industry. The public also have the right to make informed choices and accurate information should be available on a products purity, effectiveness and safety regardless of the origin.

Public safety and health freedom

In addition, a mass of research on the nutrient status of adults in western countries tell us that most people's dietary intake falls considerably short of providing the optimal intake of nutrients. I challenge each of you to look at the Dietary Guidelines for Americans published by the Department of Health and Human Services (HHS) and the Department of Agriculture (USDA) last month and compare it with your diet. My guess is that most of us will fall short of the guidelines. All individuals need to have the opportunity to safely supplement their diet with safe and effective supplements.

In choosing a supplement under the present system, the most prudent advice that can be given is caveat emptor. As consumers I believe we are entitled to a better system and as members of the pharmaceutical community I believe we have a responsibility to meet the demand for safe and effective supplements. Is the goal of public safety and health freedom really unobtainable?