FDA
regulations for supplements, vitamins and herbal products -
Acceptable Terms and Words for Structure and Function Claims and role in the
nutraceutical industry
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.
2015
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.
2014
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.''
Adjectives Allowed
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.
Anti-inflammatory 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.
Cholesterol
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.
Diabetes
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.
Immune System
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.
Headache
``Nervous tension headache'' is a disease claim
because tension headache meets the definition of a disease.
Mental Health
Products labeled ``to help restore mental alertness or wakefulness when
experiencing fatigue or drowsiness'' should not imply treatment of
either of these diseases.
Menopause
"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.
Musculoskeletal System
"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.
Muscle Tissue
"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.
PMS
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.
Prostate
``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).
Respiratory System
Maintains healthy lung function,'' would be an acceptable structure/function claim.
Sexual Health
"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.
Sleep Claims
``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.
Urinary System
``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.
FDA Scientists
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.
DSHEA law
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.
2009
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.
2010
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.
Questions and
comments
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.