regulations for supplements, vitamins and herbal products -
Acceptable Terms and Words for Structure and Function Claims and role in the
August 14 2016 by Ray Sahelian, M.D.
The Dietary Supplement Health and Education Act, approved by Congress in
1994, defines nutritional supplements as products that: Are intended to
supplement the diet; Contain one or more ingredients such as vitamins, herbs, or
amino acids, or other nutrients; Are intended to be taken by mouth; Are labeled
as nutritional supplements.
The Food and Drug Administration (FDA) once regulated nutritional supplements the same way it does foods, but that changed as of August 2007. The FDA's new good manufacturing practices ruling ensures that supplements: Are produced in a quality manner; Do not contain contaminants or impurities; Are accurately labeled; If a claim is made, the manufacturer must notify the FDA.
The U.S. Food and Drug Administration approved Praluent, the first of a powerful new class of injected, cholesterol-lowering drugs. Praluent (alirocumab) sharply cuts levels of LDL ("bad") cholesterol, and is one of a group of newly developed drugs called PCSK9 inhibitors.
FDA proposes changes to food nutrition labels, including bigger emphasis on added sugars and certain nutrients. Those "Nutrition Facts" labels that are plastered on nearly every food package found in grocery stores are getting a new look. Calories would be in larger, bolder type, and consumers for the first time would know whether foods have added sugars under label changes being proposed by the Obama administration. Serving sizes would be updated to make them more realistic. A serving of ice cream, for example, would double to a full cup, closer to what people actually eat.
Congress defined the term "dietary supplement" in the Dietary Supplement Health and Education Act (DSHEA) of 1994. A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet. Whatever their form may be, DSHEA places dietary supplements in a special category under the general umbrella of "foods," not drugs, and requires that every supplement be labeled a dietary supplement.
FDA and structure function claims, why certain words are chosen
The administration has provided the following examples of acceptable structure/function claims: ``Reduces stress and frustration,'' ``inhibits platelet aggregation,'' and ``improves absentmindedness.'' The agency also stated that if the context did not suggest treatment or prevention of a disease, a claim that a substance helps maintain normal function would not ordinarily be a disease claim. Examples included: ``Helps maintain a healthy cholesterol level,'' or ``helps maintain regularity.'' but that the final report concluded that ``statements that mention a body system, organ, or function affected by the supplement using terms such as `stimulate,' `maintain,' `support,' `regulate,' or `promote' can be appropriate when the statements do not suggest disease prevention or treatment or use for a serious health condition that is beyond the ability of the consumer to evaluate.''
Use of "augment,'' ``strengthen,'' ``reduce,'' ``improve,'' ``modify,'' ``inhibit,'' ``protect,'' or ``defend.'' may be appropriate in some contexts, i.e., when the statements do not suggest disease prevention or treatment use. If, however, the use of these terms implies that the dietary supplement augments a particular therapy or drug action or otherwise suggests an effect on disease, the agency will consider the statement a disease claim. FDA agrees that ``tonic'' is not a disease claim. ``Tonic'' is commonly understood as a general term for anything that refreshes, and, by itself, would not be considered to constitute a disease claim.
The term ``anti-inflammatory'' is, strongly associated with treatment of certain serious gastrointestinal diseases, and would constitute a disease claim.
Anxiety and Stress
The following are allowed claims: "Occasional simple nervous tension,'' ``nervousness due to common every day overwork and fatigue,'' ``a relaxed feeling,'' ``calming down and relaxing,'' ``gently soothe away the tension,'' ``calmative,'' ``resolving that irritability that ruins your day,'' ``helps you relax,'' ``restlessness,'' ``nervous irritability,'' and ``when you're under occasional stress, helps you work relaxed'' are all acceptable structure/function claims, because all suggest occasional rather than long-term or chronic mood changes. No claims can be made that a particular supplement cures or treats anxiety.
Appetite Suppressant and Weight Loss
FDA does not agree that ``appetite suppressant'' should be considered a disease claim. Although obesity is a disease, overweight is not. An appetite suppressant may be intended for ordinary weight loss, rather than as a treatment for obesity. Therefore, ``appetite suppressant'' would only be considered a disease claim in a context where it implies use for obesity.
Maintaining cholesterol levels within the normal range is essential to the structure and function of the body for reasons other than prevention of heart disease. Although many people think of cholesterol solely in terms of the negative role of elevated cholesterol in heart disease, normal cholesterol levels play a positive role in maintaining a healthy body. Cholesterol is a necessary constituent of cell membranes and of myelin, the sheath that coats nerves. Cholesterol is also required for the synthesis of steroid hormones, which are essential for life. Finally, cholesterol is required for the production of bile in the liver, making possible absorption of dietary fat and fat soluble vitamins. Thus, a claim that a dietary supplement helps maintain cholesterol levels that are already within the normal range does not necessarily imply disease.
Terms can be used that imply healthy blood sugar level management, but no claim can be made that a particular dietary supplement treats diabetes or cures the disease. FDA, as of 2010, allows Avandia to be prescribed by doctors.
Energy and Stamina
"Boosts stamina" is acceptable. ``Helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness,'' is an acceptable structure/function claim because occasional fatigue and drowsiness are not characteristic symptoms of a specific disease or class of diseases. Chronic fatigue or daytime drowsiness can be symptoms of chronic fatigue syndrome and narcolepsy, respectively.
A statement of support for the immune system, by itself, conveys no specific reference to disease treatment or prevention. The claim that vitamin A is necessary to maintaining a healthy immune response does not imply that a specific disease or class of diseases will be prevented. In contrast, a claim that a product ``supports the body's antiviral capabilities'' represents a claim of treatment or prevention of a specific class of diseases, those caused by viruses (e.g., colds, hepatitis, or HIV infection). The claims ``dietary support during the cold and flu season'' and ``promotes general well-being during the cold and flu season'' are disease claims because they imply that the product will prevent colds and flu or will mitigate the symptoms of those diseases.
Gastrointestinal System - Intestinal Flora
`Helps maintain intestinal flora'' is a permissible structure/function claim. "Relief of sour stomach'' and ``upset stomach'' are acceptable structure/function claims, because they refer to a nonspecific group of conditions that have a variety of causes, many of which are not disease-related. Thus, they are not characteristic of a specific disease or class of diseases. Although ``relief of heartburn'' and ``relief of acid indigestion'' without further qualification are not appropriate structure/function claims, the agency has concluded that ``occasional heartburn'' and ``occasional acid indigestion'' can also be considered nonspecific symptoms, arising as they do in overindulgence and other sporadic situations. These claims could be appropriate structure/function claims. In contrast, ``recurrent'' or ``persistent'' heartburn and acid indigestion can be hallmarks of significant illness, and are therefore disease claims. Alleviates the symptoms referred to as gas,'' ``alleviates bloating,'' ``alleviates pressure,'' ``alleviates fullness,'' and ``alleviates stuffed feeling'' are acceptable. ``For the prevention and treatment of the nausea, vomiting, or dizziness associated with motion,'' is also a permitted structure/function claim.
``Nervous tension headache'' is a disease claim because tension headache meets the definition of a disease.
Products labeled ``to help restore mental alertness or wakefulness when experiencing fatigue or drowsiness'' should not imply treatment of either of these diseases.
"Supportive for menopausal women'' is an appropriate structure/function claims ``Supportive for menopausal women'' is acceptable because it is a general statement that does not refer to symptoms of any conditions at all. Claims about diminishing the normal symptomatology of menopause would also be acceptable structure/function claims, if they did not suggest, for example, prevention or treatment of osteoporosis, or another disease associated with this state.
"Helps support cartilage and joint function,'' would be a permissible structure/function claim, because it relates to maintaining normal function rather than treating joint pain.
"Helps increase muscle size, and helps enhance muscle tone'' are acceptable structure/function claims, because they do not refer to any disease. However a claim to increase muscle size implies an effect that may subject the product regulation as an anabolic steroid under the Controlled Substances Act.
FDA agrees that ``supports a normal, healthy attitude during PMS'' is an appropriate structure function claim. `Supports a normal, healthy attitude during PMS'' is acceptable because PMS is generally a common, mild condition associated with a normal physiologic process. Claims about diminishing the normal symptomatology of premenstrual syndrome would also be acceptable structure/function claims, if they did not suggest, for example, prevention or treatment of another disease associated with this state.
``Helps to maintain normal urine flow in men over 50 years old,'' is an implied disease claim because the average or ``normal'' state in men over 50 years old is diminishing urine flow, in most cases due to BPH, so that the apparent ``maintenance'' really represents a claim of improvement (treatment).
Maintains healthy lung function,'' would be an acceptable structure/function claim.
"Arouses or increases sexual desire and improves sexual
performance'' is an acceptable structure/function claim because it does
not imply treatment of a disease. ``Helps restore sexual vigor,
potency, and performance,'' ``improves performance, staying power, and
sexual potency,'' and ``builds virility and sexual potency'' are
disease claims because they use the term ``potency,'' which implies
treatment of impotence, a disease. If, however, these claims made clear
that they were intended solely for decreased sexual function associated
with aging, they could be acceptable structure/function claims.
Libido should be an
acceptable term since it does not imply a disease.
``For the relief of occasional sleeplessness'' is an acceptable structure/function claim, because occasional sleeplessness is not a characteristic symptom of a disease. ``Helps you fall asleep if you have difficulty falling asleep,'' and ``helps to reduce difficulty falling asleep'' are disease claims because, unless the context makes clear that the product is only for occasional sleeplessness, they imply treatment of insomnia, a disease.
``Deters bacteria from adhering to the wall of the bladder and urinary tract'' is not an acceptable structure/function claim because it implies prevention of bacterial infections of the bladder and urinary tract.
Use of Prescription or Rx abbreviation
The use of the word ``prescription'' or its abbreviation ``Rx'' in the name of the product should not automatically be interpreted as a disease claim. Although these terms imply that the product is a prescription drug, some prescription drugs are intended for nondisease conditions. Therefore, if nothing else in the labeling suggests a disease use, the agency will not consider the use of ``prescription'' or ``Rx'' to be an implied disease claim. The agency notes, however, that the use of these terms on dietary supplement products may deceive consumers into thinking that they are purchasing a prescription drug without a prescription. Thus, use of the terms ``prescription'' or ``Rx'' is misleading and will misbrand the product under section 403(a)(1) of the act if, in the context of the labeling as a whole, the terms imply that the product is a prescription drug.
Adverse or Side Effects
FDA agrees that it is important to inform consumers about potential adverse effects or drug interactions for specific dietary supplement ingredients. In fact, dietary supplement labeling, like the labeling of other FDA-regulated products, is required to include all facts that are material in light of consequences that may result from use of the product or representations made about it. This provision is not intended in any way to preclude truthful adverse event or drug interaction information from appearing in a dietary supplement's labeling.
Supplement used to prevent side effect of a drug
FDA allows a claim that a product is useful because it counterbalances the effects of a drug in depleting a nutrient or interfering with the metabolism of a nutrient would be acceptable as a structure/function statement. Such a claim would not suggest treatment of an adverse reaction that meets the definition of disease. However, if the claim expressly or impliedly suggests that the supplement is intended to augment a specific drug, drug action, or therapy for a disease, or serve the same purpose as a specific drug or therapy for a disease, then the statement may be considered a disease claim.
The following are examples of conditions about which structure/ function claims could be made: (1) Morning sickness associated with pregnancy; (2) leg edema associated with pregnancy; (3) mild mood changes, cramps, and edema associated with the menstrual cycle; (4) hot flashes; (5) wrinkles; (6) other signs of aging on the skin, e.g., liver spots, spider veins; (7) presbyopia (inability to change focus from near to far and vice versa) associated with aging; (8) mild memory problems associated with aging; (9) hair loss associated with aging; and (10) noncystic acne.
2006 - Fifteen percent of about 1,000 U.S. Food and Drug Administration scientists say they have been wrongly asked to withhold or alter information or their conclusions in agency documents, according to a survey by the Union of Concerned Scientists. The group sent questionnaires to nearly 6,000 FDA scientists. Of the 997 who responded anonymously, 15 percent said they had been "asked, for non-scientific reasons, to inappropriately exclude or alter technical information or my conclusions in an FDA scientific document." "That number should be zero," said Francesca Grifo, head of the group's scientific integrity program. Seventeen percent said they had been asked by FDA officials "to provide incomplete, inaccurate or misleading information to the public, regulated industry, media or elected/senior government officials." Forty percent said they feared retaliation if they voiced concerns about product safety in public. Two FDA scientists have publicly stated in recent years that their concerns about medicines were downplayed or dismissed by superiors. Another top FDA women's health official resigned to protest what she said was political interference with science. The survey was co-sponsored by Public Employees for Environmental Responsibility, a group created to promote environmental ethics and accountability. In a 2002 survey by the Department of Health and Human Services inspector general, about 20 percent of FDA scientists said they were pressured to approve or recommend approval of a medicine despite reservations about risks or effectiveness.
FDA Orphan Drugs
Elaprase was designated as an orphan product by FDA and approved in 2006.
FDA Conflict of Interest
Former FDA chief Lester Crawford was charged in October, 2006 with lying about his ownership of stock in companies regulated by his agency.
The Justice Department accused the former head of the Food and Drug Administration with falsely reporting that he had sold stock in companies when he continued holding onto shares in the firms governed by FDA rules. Crawford also failed to disclose his income from exercising stock options in Embrex, an agriculture biotechnology company regulated by FDA. Crawford had been a member of the board of directors of Embrex.
The former FDA chief was accused of making a false writing and conflict of interest. The court papers say that Crawford chaired FDA’s Obesity Working Group at a time when he and his wife owned stock in soft drink and snack food manufacturer Pepsico and food product manufacturer Sysco. The panel Crawford was chairing was making decisions affecting food and soft drink manufacturers.
The federal Dietary Supplement and Nonprescription Drug Consumer Protection Act requires manufacturers of
dietary supplements and nonprescription drugs to notify the FDA about serious adverse events related to their products. Manufacturers must report deaths; life-threatening experiences; inpatient hospitalizations; persistent or significant disability or incapacity; birth defects; or the need for medical intervention to prevent any such problems. Manufacturers will also have to place a telephone number or address on product labels so consumers can
contact them. Other parts of DSHEA make it difficult for the FDA to ban dietary supplements and herbs.
The Food and Drug Administration is taking aim at caffeinated alcoholic drinks, saying it will pull them off the market unless manufacturers can prove the beverages are safe to drink. The FDA sent letters to nearly 30 companies, giving them 30 days to provide evidence that their drinks don't pose health or safety risks. The FDA hasn't approved the use of caffeine in alcoholic beverages, and companies might have to show that experts generally think mixing caffeine and alcohol is safe for consumers.
The number of U.S. Food and Drug Administration warnings to drugmakers and others for questionable drug promotion has nearly doubled since President Barack Obama took office a year ago, a top FDA official said on Friday. The agency sent 41 enforcement letters in 2009 compared with 21 letters in 2008.
Q. I'm a little surprized to see Dr. Sahelian refer to the FDA in certain articles on his site due to the fact that the FDA is a very corrupt organization ord isorganization and supports big pharma over the use of dietary supplements.
A. As with any governmental organization in the Unites States, the FDA has some honest people working there and also some who are inclined to do some favoritism. Not everything the FDA does is bad and not everything they do is good, either.
Q. Why are
substances that are clearly deleterious to health appearing in the American food
supply, and should we expect "personal responsibility" to get rid of them? It
came to my attention recently that bromine is a substance that has
no positive function in the body. Yet, the PepsiCo corporation sells a beverage named "Mountain
Dew" that contains brominated vegetable oil. This product is apparently very
popular among youth in the American south, and there are known cases of high
consumption (e.g. 5 bottles per day) leading to behavioral disorders. There are
of course many examples like this. I feel as though the FDA is no longer
performing the function for which it was formed. On the other hand, perhaps this
is nothing more than a matter of
personal responsibility. How do you view this?
A. Each case has to be evaluated separately. There are few black and white answers, many fall in the grey zone and a full understanding of each topic has to done before giving an opinion as to weather it falls in the regulation or personal responsibility category.
Q. Given that you personally feel that high
dosages of tyrosine or DHEA and certain other nutritional supplements cause adverse
affects, is there any regulation or FDA recommended dosage? I have had
enormous problems with tyrosine in the past that are too dramatic to even
begin to tell you. Where, if anywhere are the dangers of supplements
mentioned or how are they regulated?
A. You ask a good question that deserves a somewhat philosophical answer. There are no official nutritional supplement dosage guidelines (except for certain well-known vitamins and minerals) since many such guidelines would be somewhat arbitrary and open to significant differences of opinion among various scientists. And how do we know that government officials are any more knowledgeable (or honest) than certain doctors and nutritionists who have first hand knowledge of these nutritional supplements in their clinical practice? There are thousands of herbs and individual supplements, and tens of thousands of combination formulas. How can any independent or governmental organization ever keep up knowing the appropriate dosages of these supplements, herbs, and combination formulas?
If strict governmental guidelines are placed on nutritional supplements dosages (whether it be tyrosine, alpha lipoic acid, curcumin, mangosteen, noni, coq10, melatonin, and others), why not then follow the same logic and limit hard liquor bottle sizes to only six ounces and forbid the sale of more than one bottle at a time since there are serious risks in drinking excess alcohol? What about limiting sales of sugar-laden sodas that cause obesity and diabetes? Drinking more than one soda a day is associated with an increased incidence of metabolic syndrome. We live in a society that should accept the fact that there are risks to some of the products and foods we consume. If we were to tightly regulate every little detail of a citizen's life and what or how much they can ingest of a food, drink, or supplement, we would no longer have the freedoms we currently enjoy. Each citizen is responsible for their own health and to learn as much about a food, drink, or nutritional supplement before they ingest it.