This act, referred to as DSHEA (D'Shea), kept dietary supplements regulated as foods, but created a subcategory within the food regulations that consider certain differences in the ingredients that can be used in dietary supplements, more then in conventional foods, and labeling; Supplement Facts versus Nutrition Facts ingredient panels.
The DSHEA and previous food laws permit the use of certain types of claims about how the ingredients affect the structure and function of the body, and in some cases, how the ingredients help prevent certain diseases.
I have been taking supplements for over 30 years, and making and selling supplements for 2 decades, and I find it borderline negligence the way people are lead in to thinking supplements are not legal. They are not only legal, they are backed by tens and thousands of scientific studies which report on the numerous health benefits dietary supplements have to offer.
This article is written to provide an overview of the claims that can be used on food and dietary supplements. Now reading through this regulatory stuff may be a bit grueling for some of readers, but no more grueling then a high intensity workout.
The claims for foods and dietary supplements that relate to how a product affects your body are generally divided into two categories:
- Health claims and
- Structure/function claims.
Health Claims: Foods And Supplements To Prevent Diseases
Health claims describe a relationship between a type of food, food ingredient, or dietary supplement ingredient, and reducing risk of a disease or health-related condition. Technically speaking, a "health claim" statement by definition has two essential components:
- A substance (whether a food, food component, or dietary ingredient) and
- A disease or health-related condition.
By contrast statements that address a role of a specific substance in maintaining normal healthy structures or functions of the body are considered to be structure/function claims. These types of claims are discussed in this article. The following information reviews some of the specific laws that govern health claims that appear on foods and dietary supplements.
NLEA And DSHEA Authorized Health Claims
The Nutrition Labeling and Education Act (NLEA) of 1990, the Dietary Supplement Act of 1992, and the Dietary Supplement Health and Education Act of 1994 (DSHEA), provide for health claims used on labels that characterize a relationship between a food, a food component, dietary ingredient, or dietary supplement and risk of a disease (for example, "diets high in calcium may reduce the risk of osteoporosis").
FDA authorizes these types of health claims based on an extensive review of the scientific literature. Yes, FDA not only regulates dietary supplements, FDA authorizes how some dietary supplements even prevent diseases.
- Calcium intake and the reduction of osteoporosis.
- Low Sodium intake and the reduction of hypertension.
- Low fat intake and reduction in cancer (fish & game meats: extra lean)
- Low saturated fat and cholesterol intake and the reduction of coronary hearth disease.
- Intake of fiber containing grain products, fruits and vegetables and the reduction of cancer.
- Intake of fruits and vegetables that contain fiber and the reduction of coronary heart disease.
- Intake of fruits and vegetables and the reduction of cancer.
- Intake of folate (folic acid) and the reduction in neural tube birth defects.
- Intake of dietary sugar free product, sweetened with sugar alcohols and the reduction of dental caries. (Sugar alcohols include: be xylitol, sorbitol, mannitol, maltitol, isomalt, lactitol, hydrogenated starch hydrolysates, hydrogenated glucose syrups, erythritol, or a combination.)
- Intake of soluble fiber ( -glucan soluble fiber) from certain foods and reduction of coronary heart disease. Include either (1) one or more eligible sources of whole oats, containing at least 0.75 g whole oat soluble fiber per RA; or (2) psyllium seed husk containing at least 1.7 g of psyllium husk soluble fiber per RA; or (3) Oatrim (BETATRIM)).
- Intake of soy protein and reduction of coronary hearth disease.
- Intake of plant sterols and plant stanol esters and reduction of coronary heart disease.
It is interesting to see how the government is finally recognizing what fitness minded people have know all along, that eating a healthy diet can reduce your risk of many diseases including deadly ones like cancer and heart diseases. While this is short list, it is slowly growing as companies submit more data to the FDA to review. Current submissions under review include foods and dietary supplements that can reduce the risk or diseases like diabetes and osteoarthritis.
From a real-life perspective, there is a big take home lesson when it comes to nutrition, or the lack there of, when people blindly following fad diets, like the low carb diet craze. You notice from the above that many carbohydrate containing foods actually contain healthy substances to help you reduce your risk of diseases.
So this means that fruits, vegetables, fiber containing foods and supplements, and whole grain foods (from the list that follows), are vital to your health. Athletic people need carbs to be healthy and energetic. So, please don't get caught up in the gimmicky diet fads. You know the healthy way to loss body fat, and if you don't I'll be writing an article about it for you, due out in January 2005 - The Natural Thin Diet. Now back to health claims.
Health Claims Based On Authoritative Statements
The Food and Drug Administration Modernization Act of 1997 (FDAMA) provides another way for the use of a health claim on foods to be authorized. FDAMA allows certain health claims to be made as a result of a successful notification to FDA of a health claim based on an "authoritative statement" from a scientific body of the U.S. Government or the National Academy of Sciences.
For example, the National Academy of Sciences published a scientific review book called "Diet and Health". In this book, based on the group of expert's evaluation, they mention again and again how eating certain foods, or eliminating certain foods/substance from the diet results in the reduction of diseases. A person or company just has to find these statements, and send them in to the FDA for their review. Within months, a health claim can be approved.
One problem I see is that there are not enough companies doing this. The other problem is that these types of claims are currently only permitted for conventional foods, not dietary supplements. The FDA is supposed to be working on a separate program for dietary supplement health claims based on authoritative statements, but has not finalized it yet. Examples of health claims based on authoritative statements include:
Summary of Health Claims Based on Authoritative Statements
- Intake of whole grain foods and reduction of heart disease and certain cancers. (I guess the health food people were right about this one. I was lucky to have started purchasing my sports supplements in health food stores back in 1969, because I also got turned on to health foods. I hope you get turned on to health foods to. They are a little more expensive then typical grocery store foods, but healthier.
If you are not already doing so, start eating some health foods. As an aside, when I give lectures to groups of people, in particular fitness trainers, I am amazed how most of these fitness people are still not eating a healthy diet, and most of them have not been to a health food store. Do your body some good and start eating health foods.)
- Intake of potassium foods and reduction of high blood pressure and stroke. Foods must be a good source of potassium, low sodium, low total fat, low saturated fat, and low cholesterol.
- Choline was given nutrient status by the FDA. Choline functions as a precursor for acetylcholine, phospholipids and the methyl donor betaine. The primary criterion used to estimate the Adequate Intake (AI) for choline is the prevention of liver damage as assessed by measuring serum alanine aminotransferase levels. The AI for adults is 550 mg/day of choline for men and 425 mg/day for women. Choline has many functions in the body, including in the nervous system and in fatty acid metabolism.
Qualified Health Claims
This is a relatively new category of health claims, which resulted from the efforts of a group of health advocates. This group of people believed that the initial system of health claims that the FDA used, was too much like the drug approval process, and was prohibiting using the findings of new, emerging nutrition research that could benefit the consumer. After all we are talking about pasta not Prozac.
This group wanted an additional category of health claims, and actually spent a ton of money suing the FDA in federal court, and eventually won. The court ruled that the FDA must develop a new system of health claim approvals that will approve health claims based on emerging research; keep in mind that this did not replace the previous categories, just added to them.
As a condition of this use, however, the claims must be followed by a disclaimer that lets consumers know the research is supportive and not conclusive. You see, in the world of science, one or two studies does not make a finding conclusive; putting common sense aside, of course, when dealing with the government. Both conventional foods and dietary supplements may use qualified health claims.
Summary of Qualified Health Claims
- Qualified Claims About Cancer Risk
- Selenium and reduction/prevention of certain cancers.
- Antioxidant vitamins (C& E) and reduction/prevention of certain cancers.
- Qualified Claims About Cardiovascular Disease Risk
- Eating nuts and reduction of heart disease.
- Eating walnuts reduction of heart disease.
- Omega-3 fatty acids consumption and reduction of coronary heart disease.
- B vitamins intake and reduction of vascular disease.
- Qualified Claims About Cognitive Function
- Phosphatidylserine consumption and reduction in cognitive dysfunction and dementia.
- Qualified Claims About Neural Tube Birth Defects
- 0.8 mg folic acid supplements consumption and reduction in neural tube birth defects.
Structure/Function Claims: Foods And Supplements To Benefit The Function And Structure Of Your Body
Now these are the claims most of you encounter when purchasing your sports nutrition products and other dietary supplements. "Increase muscle", "Stimulate energy" and "Support Testosterone Production" for example. Structure/function claims have historically appeared on the labels of conventional foods and dietary supplements as well as drugs. However, DSHEA established some special procedures for the use of such claims on dietary supplement labels.
Structure/function claims describe the role of a nutrient or dietary ingredient intended to affect normal structure or function in humans, for example, "calcium builds strong bones." In addition, they may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function, for example, "fiber maintains bowel regularity," or "antioxidants maintain cell integrity," or they may describe general well-being from consumption of a nutrient or dietary ingredient.
The dietary supplement manufacturer is responsible for ensuring the accuracy and truthfulness of these claims; they are not pre-approved by FDA like health claims, but must be truthful and not misleading. If a dietary supplement label includes such a claim, it must state in a "disclaimer" that FDA has not evaluated the claim. The disclaimer must also state that the dietary supplement product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim.
In comparison a health claim states how a food or dietary supplement or ingredient may reduce the risk of a disease, not treat it. So, food or dietary supplement on the market that claims it can be used to treat a disease is considered an unapproved drug by the FDA. Please note however, the research is filled with thousands of scientific studies about how foods and dietary supplements can help treat diseases. Botanicals for example are used as medicines throughout the world.
In other countries SAMe, glucosamine, chondroitin sulfate and many other ingredients found in foods and dietary supplements are used to successfully treat a variety of diseases. The FDA is currently in the process of approving a new Health Claim which will permit stating that glucosamine and chondroitin sulfate may help reduce the risk of osteoarthritis, reduce joint narrowing, etc.
The moral to this situation is that unless FDA has approved something as a drug to treat a disease, legally supplement and food companies cannot make the claim. Obviously though, millions of people have made the connection themselves from reading books and articles, and are using dietary supplements to treat their diseases.
If you are one of them, I encourage you to do so under the supervision of your doctor or other health professional. Even though they might not be an expert in complementary medicine, they can certainly monitor your progress, just in case your health takes a turn for the worse.
Another aside, saw palmetto extract is used as a drug to treat BPH (benign prostatic hypertrophy or hyperplasia), enlarged prostate. The research is clear on this. Even experts in the USA agree it works. However, the prostate can also enlarge from cancer. So, this underscores the importance of working with your doctor when you chose to self prescribe complementary medicine for disorders that can have serious outcomes.
According to the regulations manufacturers of dietary supplements that make structure/function claims on labels or in labeling (such as brochures and advertising) must submit a notification to FDA no later than 30 days after marketing the dietary supplement that includes the text of the structure/function claim. Make the submission after the product is being sold? Yes, this is the way the FDA regulates OTC drugs as well.
If you or I were going to market our own brand of aspirin, for example, we would go and have it made by a contract manufacturer (licensed by FDA). Then after we started selling it, we need to send in the label to FDA. After the fact, the FDA makes its review to determine if there are any issues with the product labeling. In the case of dietary supplements, the FDA will review the dietary supplement claims only from the point of view if a drug claim is being made.
They do not evaluate if the claim is supported by studies. If they think a drug claim is being made, like saw palmetto helps reduce the size of the prostate (which implies treating BPH), then the FDA sends the manufacturer a warning letter to change the claim.
More recently, the FDA has been challenging some companies directly to see if they have the scientific studies to support the claims on their labels. This type of information exchange may end up with the manufacturer being able to support their claim, or if not, having to change the claim.
Dietary supplements may also have claims on their labels that describe a benefit related to a nutrient deficiency disease (like vitamin C and scurvy), as long as the statement also tells how widespread such a disease is in the United States.
Examples of Typical Structure/Function Claims Found On Dietary Supplement Labels
- Promotes muscle growth.
- Stimulates mental and physical energy.
- Maintains anabolic hormone production.
- Carnitine increases fatty acid metabolism.
- Scientific studies have shown that regular consumption of carotenes helps maintain a strong, healthy immune system.
- Phyto-chemicals are a key to good health.
- Good for antioxidant and cellular health.
- Research shows that antioxidants help fight free radical damage caused by environmental things and other toxic insults.
- CoQ10 is a nutrient that supports heart function and promotes energy production in cells.
- Alpha-lipoic acid helps maintain the function of the cardiovascular system and acts as a protective antioxidant.
- Supports healthy heart function as the body ages.
- Helps support cardiovascular function and a healthy circulation system.
- Helps the walls of arteries, capillaries and veins stay flexible and strong.
- Nutritionally supports healthy vein function.
- Aids digestion naturally.
- Nutritionally supports normal digestive processes.
- Acidophilus organisms help maintain a healthy digestive tract.
- Nutritionally supports normal energy production processes.
- Supports endurance and stamina.
- Promotes energy and mental clarity.
- Helps maintain physical performance.
- Supports normal joint function and lubrication.
- Promotes healthy joints and cartilage.
- Nutritional formula for optimal bone formation.
- Vitamin D is necessary for healthy teeth and bones and enhances calcium absorption.
- For strong bones and teeth.
- Nutritional support for connective tissue.
- Promotes relaxation.
- Supports normal memory function and reduces absentmindedness.
- Positive mood enhancer.
- Nutritional support for mental function.
- Nourishment for your nervous system.
- Shown to have relaxing effects and sleep-promoting activities.
- Supports natural sleep, normal sleep patterns.
- Ginkgo supplements benefit memory, mental clarity and alertness.
- Naturally relaxing dietary supplements.
- Promotes a calm, healthy attitude.
- Nutritionally supports feelings of well being.
- Bilberry has been proven to support healthy eye function and help enhance night vision.
- Enhances visual health.
- Supports healthy vision function.
- Vitamin A is necessary for new cell growth and healthy tissues and is essential for vision in dim light.
- Supports healthy liver function.
- Traditional herb for kidney function.
- Helps promote urinary tract health.
- Nutritional support to help maintain a healthy prostate.
- Nutritional support for the male reproductive system.
- Herbal support for women.
- Required for reproductive function.
One of the primary requirements for making claims on dietary supplement labels, or submissions to the FDA for approval of new health claims is that the claims must be substantiated by significant scientific agreement and evidence. In the case of dietary supplements, the companies making claims of nutritional support must maintain substantiation files at their place of business. However, at this point in time none of the legislation sets out a specific definition of what exactly constitutes adequate substantiation.
The kind and amount of substantiation needed to support a claim will depend upon the statement(s) being made. For example, when making a statement about how a vitamin or a mineral is related to a classic nutrient deficiency disease, these types of conditions are clearly established and well known and are considered textbook knowledge. On the other hand, some structure/function claims require well controlled clinical studies as evidence to support a claim. The "gold standard" of scientific studies is those studies that are published in peer-reviewed scientific journals that have high credibility.
In the arena of scientific research, having your study submitted to a journal for publication, which is reviewed by other scientists, is considered the preferred process to verify that the research results are well founded. This level of peer review scrutiny is required because no researcher is perfect, and complex issues when conducting scientific studies can sometimes be overlooked.
Therefore, peer-reviewed journal articles are considered the highest standard of credible scientific research. However, other types of studies that are not reported in peer-reviewed journals are considered valid evidence in support of a structure/function claim, in addition to the studies in peer-reviewed journal. In this way the total body of knowledge is looked at when determining whether or not a structure/function claim is considered to be truthful and not misleading.
In Vitro Studies
Scientific research can include a wide range of activities. For example, it can include research called in vitro. These in vitro studies are usually conducted in test tubes outside of living organisms. In vitro studies are useful when scientists are trying to figure out specific aspects of the function or biochemistry of a particular compound. Researchers use in vitro studies to help sort out details that are observed in living systems. However, in vitro studies on their own usually are not adequate to support a claim.
Ex Vivo Studies
Another type of study is called ex vivo. These studies use parts of animals or humans experimentally outside the body, and subject to various tests. For example, a piece of vein can be taken out of the leg of a patient, and studied in a Petrie dish or test tube for effects of different types of nutrients or other substances on its structure. Ex vivo tests commonly use living cells, to measure the effects of a drug or dietary supplement ingredient. Ex vivo studies on there own usually are not adequate to support a claim.
In Vivo Studies
In vivo studies are conducted in living systems. These include experimental studies using animals, and experimental studies on humans, usually called clinical studies. The use of animal studies is beneficial in many instances, for example, when the toxicity of the substance is being tested is unknown. However, animal studies on their own are usually not adequate to support a claim.
Well conducted clinical studies must exist to verify the effects of a dietary supplement in the human body. This is the standard of scientific approach that has emerged during the 20th Century, which has been the driving force behind modern medicine. However at the close of the 20th Century, with an estimated 40% of the adult population seeking some sort of alternative medicine, it is obvious that a combination of scientific medicine and alternative medical treatments is sometimes needed.
I point out in my lectures that just because scientific studies have not been conducted yet, does not mean that a dietary supplement ingredient should automatically be judged ineffective. Some ingredients have a history of use which demonstrates their effectiveness. For example it is well known what effects you can expect from drinking a glass or two of prune juice. But, there are few well controlled clinical studies to verify laxative effects.
Being a scientist during the past 20 years in the dietary supplement and sports nutrition industry, I adhere to the highest standards of scientific evidence, that is, the existence of human studies, when creating products However, there are some instances, in particular with herbal products, where legitimate traditional uses are also recognized as adequate evidence.
I also agree that basing product creation on biochemistry, anatomy and physiology principles is sometimes a viable approach, in the absence of good clinical human studies. However, in light of this allowance, I do try to draw the line on the conservative side of safety and efficacy, because I would rather err on the side of safety then stretch weak evidence to create a situation that may not be in your best interest.
In my experience the structure/function claims are very applicable to sports nutrition products. After all, athletes want to improve the structure and function of their body. Protein for muscle growth and recover; creatine for increasing muscle fiber size, strength and stamina; carnitine for improving fatty acid utilization and endurance; CLA for increasing fat loss; and so on. As the field of sports nutrition progresses, so does the research about how nutrients effect the body, which leads to more substantiation that something works, like whey protein isolate and creatine, and to the introduction of new sports nutrition products.
The Federal Trade Commission's Role In Regulating Dietary Supplement Claims
Yes, more regulations! In addition to the FDA's involvement regulating dietary supplement products, the Federal Trade Commission (FTC) plays a role. Concerning dietary supplements, the FDA's responsibility is for the regulation of claims on product labeling, which includes packaging, inserts, and other promotional materials distributed at the product point of sale.
The FTC, on the other hand, has the primary responsibility for regulating claims in advertising. Recently, the FTC published specific advertising guidelines for the marketing of dietary supplement products, in response to all of the new claims that the Dietary Supplement Health and Education Act made possible. To help dietary supplement manufacturers make truthful and not misleading claims, the FTC published new guidelines in 1998.
The FTC guidelines point out that as a general rule; well-controlled human clinical studies are the most reliable form of evidence to support a claim. However, note that the FTC considers FDA approved claims, like approved health claims, substantiation in themselves.
To underscore this point about what is good substantiation, I would like to share with you a glimpse into a landmark court proceeding concerning a matter between the FTC and a dietary supplement company. The company was marketing a dietary supplement that contained a type of calcium, and the FTC challenged some of the claims being made in the advertising materials for this product.
In this case the company was marketing a certain type of calcium, supplied in the form of a chemical compound called hydroxyapatite. The FTC challenged several advertising claims made about the product and its effects on the body. This was an interesting case, because most companies usually settle with the FTC on advertising issues, before going to court. In this case, the company thought its claims well substantiated.
The FTC hired scientific experts on calcium, and the marketer of the calcium product hired their experts as well. Many scientific studies, articles, editorials and abstracts were offered as evidence in support of advertising claims. After the experts reviewed over 100 scientific studies, and other supportive materials, the judge ruled that only well-designed clinical studies would be considered as evidence.
The other scientific studies, review articles and abstracts were considered substantiation when considered in addition to the findings of well-controlled clinical studies. All articles in magazines, chapters in books, and other secondary literature were not accepted as qualified evidence at all.
After a very lengthy and expensive court proceeding, the court rendered the following decisions on the several advertising claims:
- Builds bone or increases bone thickness. (Substantiated)
- Restores lost bone. (Not Substantiated) (But note that recent studies support this)
- Halts or prevents bone loss or bone thinning. (Substantiated)
- Restores bone strength. (Not Substantiated) (But note that recent studies support this)
- Halts, prevents or treats osteoporosis. (Substantiated)
- Reduces or eliminates pain associated with bone ailments. (Not Substantiated) (But note that recent studies support this)
- Is superior to and is more effective than other forms of calcium in the prevention or treatment of bone ailment. (Not Substantiated) (Note, still not proven better then other forms of calcium)
- It is more bioavailable, more absorbable and more effectively utilized by the body than other forms of calcium. (Not Substantiated)
The outcome of this case sends a message to marketers of dietary supplements, that they better make sure they are making advertising claims based on scientific fact, not guesses. It is interesting to realize, that during and after this case, the company was never restricted from selling the calcium supplement, having to just stop making the unsubstantiated advertising claims.
It is also interesting to note, that after the fact, there is now good scientific evidence to support the claims that taking calcium supplements can restore lost bone in many cases and restore bone strength. In the world of government regulated products, look-and-see proof is not considered scientific evidence, nor is common sense.
In summary, dietary supplements and foods are indeed regulated by the FDA. There are tens and thousands of scientific studies that prove dietary supplements are safe and effective for growth, health and athletic performance. The National Institutes of Health even has an Office of Dietary Supplements, which funds research studies measuring the numerous benefits dietary supplements have to offer.
From my vast experience in the academic, scientific research and dietary supplement industries, including sports nutrition products, everybody - man & women, young and old should be taking dietary supplements every day as part of their healthy diet. Why, because in doing so you will live a longer, happier, and more productive life.
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Author: Daniel Gastelu, M.S., MFS
Reprinted with Permission. Copyright 2004 Daniel Gastelu. All rights reserved. This article is not intended to replace medical advice; consult your doctor for all matters related to your health.