Nutritional support for visual disorders is a rapidly growing area of eye care that combines the best of traditional and complementary vision care. Nutritional support is now an area of specialization for practitioners, who can today offer their patients the convenience of purchasing these products under their supervision.
Industry surveys placed the U.S. eye health ingredients market at $138 million in 2008, with a compound annual growth rate of 5.3% from 2008 to 2015.1 The U.S. is by far the most developed market for eye health products, partly due to a greater acceptance of dietary supplements and higher levels of awareness.
One survey found that more than half the U.S. adult population uses dietary supplements.2 In 2009, Americans spent more than $26 billion on nutritional supplements and herbal products.2 Additionally, most supplement users take them every day.
According to the results from the 2010 CRN Consumer Survey on Dietary Supplements, regular supplement usage remains steady.3 The online survey showed that nearly three-quarters of supplement users (74%) classify themselves as “regular” users, as opposed to occasional users (21%) or seasonal users (5%).
Regulation
So, how should eye care providers address this growing trend with their patients? Many doctors are asking themselves the same questions: Can I (or should I) legally sell nutraceuticals out of my office? Are these products regulated? Are they effective?
When addressing these questions, you should first consider the term “nutraceutical.” Although used frequently, this term has no medical relevance; it is simply marketing jargon taken from the concept of pharmaceutical agents. You cannot bill Medicare or medical insurance for a nutraceutical like you can a pharmaceutical drug.
The Dietary Supplement Health and Education Act was passed in 1994 and defines a dietary supplement as “a product taken by mouth that contains a dietary ingredient that may include vitamins, minerals, herbs or other botanicals, amino acids and substances such as enzymes, organ tissues, glandular and metabolites.”
Regulations do exist concerning dietary supplements, which are enforced by the Food and Drug Administration (FDA). The Dietary Supplement Health and Education Act (DSHEA) was passed in 1994 and defines a dietary supplement as “a product taken by mouth that contains a dietary ingredient that may include vitamins, minerals, herbs or other botanicals, amino acids and substances such as enzymes, organ tissues, glandular and metabolites.”
However, these products must include this disclaimer: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, cure, prevent or treat any disease.” This means that these products are considered similar to foods, not drugs.
But what does that say about the manufacturer’s responsibility for product safety and efficacy? Both are required, but manufacturers do not need to provide safety and efficacy data prior to a product’s public release.
The FDA’s regulation of products dictates that foods and dietary supplements do not need “premarket approval,” which is mandatory for drugs. However, drugs do not need “premarket notification,” which is a requirement for foods and dietary supplements.
A premarket submission made to the FDA must demonstrate that the device (or nutrient, in this case) to be marketed is at least as safe and effective—that is, substantially equivalent—to a legally marketed nutrient that is not subject to pre-market approval. Submitters must compare their nutrients to one or more similar legally marketed nutrients and make and support their substantial equivalency claims. Other than that, dietary supplements and drugs maintain the same requirements in the areas of labeling, GMP (good manufacturing practices) certification, facility registration and advertising.
The only other difference is that foods do not require mandatory adverse event reporting like dietary supplements and drugs. Since these are federal regulations, all states abide by these protocols. The Federal Trade Commission oversees the advertising issues surrounding promotion of nutrients and their benefits.
Education
If a practitioner is interested in ocular nutrition, it is essential that he or she acquire specific nutrition education. While we consider ourselves well educated in many areas of health, nutritional education is a specialized area that most of us have not kept up with since the days of our basic science classes. For practitioners, the real challenge is to find “authentic” education for the eye care practitioner that is not misleading or specifically sponsored by a commercial interest.
One must consider how nutrition research is conducted and how it differs from the randomized clinical trial (RCT), the gold standard for pharmaceutical research. All scientists recognize RCTs because they are such an important piece of the drug research puzzle.
However, we cannot ignore all the other research: Case-control and cohort studies, and other epidemiological data, because these reports often indicate where further research should be focused, and they may prove or disprove hypotheses as well as develop them.
The RCT is poorly suited to evaluate nutritional effects for several reasons. First, chronic diseases have long latency and multifactorial causation, so it is difficult to determine exactly when a disease process begins and how long it has been developing. Without knowing a starting point, it’s difficult to say when some treatment can be effective in preventing a disorder.
In 2009, Americans spent more than $26 billion on supplements and herbal products.
In contrast to drugs, nutrients have beneficial effects on multiple body tissues, and interact in a dynamic fashion with other nutrients found in supplements and the diet. But most RCTs can test only one or two compounds, each at a single dose, for a few years. This is too short of a period to have a significant impact on a chronic, degenerative disease that takes decades to develop.
All foods contain a variety of nutritional ingredients that are designed to work synergistically; we don’t eat spinach just because it contains lutein, for example. We would like there to be only one target tissue with drug therapy, but side effects do occur. Nutrients act in modestly beneficial ways in virtually every body system, whereas drugs act intensely on single targets.
It’s important that clinicians look at the full-spectrum of micronutrient research and evidence available, including observational studies, because they can provide a clearer picture of the benefits of supplements. Often, observational studies can better represent typical populations. These studies have a closer relationship to how foods and supplements are used in the “real world” compared to a clinical setting. Additionally, observational studies are often the only feasible or ethical approach in cases where eliminating essential nutrients, as part of the RCT study design, could be detrimental to the study population.
In an observational study, a no-exposure group is absent. One cannot require study subjects to go without a specific nutritional product for an extended period of time; there can only be different levels of intake. For example, we couldn’t ask one group of participants to stop taking vitamin C for several years and see how they fare.
We often see the uncertainty in quantitative measures of food intake due to inaccurate reporting and recall bias. Most studies ask participants to use food-intake questionnaires. Frequently, subjects fail to accurately record the type and amount of food eaten, or they forget and attempt to recall this information at a later time. Some studies actually record food intake at the beginning and end of a particular study and assume that the subjects eat similarly throughout the entire study duration.
In addition, how this food is translated into nutritional intake may be questionable. Depending on where the food was grown, how it was ripened, whether it was organic and even the weather conditions can affect the potential nutrient values of a particular food.
You should review products by companies that specialize in supplements for eye care needs. Their products should have a current, valid scientific rationale available for anyone to review, as well as a website that puts science first before price and marketing.
In addition, the company should be third-party GMP certified. These companies should offer training for you and your staff and a money-back guarantee, which shows they are confident in their products.
While we are accustomed to using samples with pharmaceutical agents, there is really no need to get free samples from a nutritional supplier—two or four vitamin pills will not likely be very effective in the first few days. Instead, ask the company if it will offer a money-back guarantee on its products.
In regard to reviewing companies, be aware that there are myriad multi-level marketing (MLM) programs in the marketplace. This is a popular way to market many products, especially nutritional products. While there are some good products that are marketed this way, MLM tends to promote the advantages of generating income over the concept of good health (“profits over patients”). So, any time a company suggests that you can earn “six-figures a month” or some such ridiculous number, just walk away. I suggest that MLM does not fit into the professional image of the eye care practitioner.
Some authorities suggest that nutrients only be purchased from large, conglomerate companies that might also deal with pharmaceutical agents. However, these companies may be less likely to make an alteration in their formulation when updated science emerges. When a company has several thousands of dollars tied up in an on-the-shelf product, it is extremely costly to simply remove those products for an updated formula. However, a smaller company has much more flexibility in this regard.
Office Protocol
So, how do you decide whether to offer ocular nutrition products in your office? It’s obviously a personal decision, but many practitioners liken this to other products they offer, such as eyeglass frames, ophthalmic lenses and contact lenses.
If you do decide to add ocular nutrition products to your practice, you should approach the patient in a professional and caring manner. In the exam room, you should be the one to bring up nutrition and supplements. When you diagnose the condition, carefully explain the options to the patient. Then, if you are recommending a supplement, hand the patient a brochure that fully explains the product you suggest. If he or she decides to purchase it right away, you should have it available to dispense as a convenience to the patient.
If the individual wants to consider it later, simply alert your office staff (via a routing slip) that you have discussed this product with the patient. They can ask the patient again if he or she wishes to make the purchase at the initial visit or at a later time.
Either way, the patient knows that it is available and what its potential benefits are.
Billing and Taxes
Many practices follow the medical model and bill for most of their services. Technically, nutritional supplements are not tax deductable, because they are OTC and are most often taken for general health purposes.
New for tax year 2010: If
you make a specific recommendation of a nutritional product for dry eye,
the patient may be eligible to write off the cost of that supplement as
a tax deduction
However, for tax filing year 2010, the IRS has published this section in its Publication 502: “You cannot include in medical expenses the cost of nutritional supplements, vitamins, herbal supplements, ‘natural medicines,’ etc. unless they are recommended by a medical practitioner as treatment for a specific medical condition diagnosed by a physician. Otherwise, these items are taken to maintain your ordinary good health, and are not for medical care.” These rules apply to Flexible Spending Accounts (FSA) and Health Savings Accounts (HSA) accounts.
Thus, if you are making a specific recommendation of a nutritional product for dry eye, the cost of that supplement may be eligible as a tax deduction. This will obviously facilitate the purchase if a patient is concerned that insurance won’t cover it. Be sure the patient confirms with his or her tax consultant that this is true for their particular situation.
The area of nutritional support for eye health is rapidly growing, and emerging science is showing more and more benefits. However, just taking a few vitamins won’t overcome a poor diet.
We need to support our patients in turning around their lifestyles to assure they not only see better into their later years but that their “health-span” is almost as long as their “life-span.” With the proper counseling, our patients can see clearly throughout their entire lifetime.
Dr. Jeffrey Anshel is the founder of Corporate Vision Consulting, and the president and founding director of the Ocular Nutrition Society.
1. Klein R, Chou CF, Klein BE, et al. Prevalence of age-related macular degeneration in the U.S. population. Arch Ophthalmol. 2011 Jan;129(1):75-8.
2. 2010 Healthy Foods Report, Nutrition Business Journal, Boulder, CO., 2010.
3. Council for Responsible Nutrition. Press Release Sept. 30, 2010. Available at:
www.crnusa.org/CRNPR10ConsumerSurvey_Usage+Confidence.html. Accessed April 7, 2011
