The manufacturer of a dietary supplement or dietary ingredient is responsible for ensuring
that the product is safe before it is marketed.
FDA is responsible for taking action against any unsafe dietary supplement product after
it reaches the market.
Manufacturers do not need to register their products with FDA or get FDA approval before
producing or selling dietary supplements.
However, they must make sure that product label
information is truthful and not misleading, and that their facilities are registered with the FDA.
All domestic and foreign companies that manufacture, package, label or hold dietary supplement,
including those involved with testing, quality control, and dietary supplement distribution
in the U.S., must comply with the Dietary Supplement Current Good Manufacturing
Practices (CGMPs) for quality control.
In addition, the manufacturer, packer, or distributor whose name appears on the
label of a dietary supplement marketed in the United States is required to submit
to FDA all serious adverse event reports associated with use of the dietary
supplement in the United States.
The DSHEA requires that a manufacturer or
distributor notify FDA if it intends to market a dietary supplement in the U.S. that
contains a "new dietary ingredient."
■ updates the list of nutrients required or permitted to be declared, the Daily Reference Values and Reference
Daily Intake values of several nutrients, and the format and appearance of the Nutrition Facts label, and
■ amends certain serving size requirements. Same would apply to "Supplements Facts" of dietary supplements labels.
FDA is not authorized to and does not review dietary supplements for effectiveness before they are
marketed unless related to health claims and qualified health claims.
A product sold as a dietary supplement and promoted on its label or in labeling as a treatment, prevention
or cure for a specific disease or condition would be considered an unapproved illegal drug.
Manufacturers may make three types of claims for their dietary supplement products :
FDA considers statements and graphics on product labels, labeling, and advertising,
including Web sites and social media, when the agency evaluates the intended use of
the product and how it is represented.
Manufacturers are responsible for ensuring that the "Supplement Facts" label and
ingredient list are accurate, that the dietary ingredients are safe.
More than half of Americans are taking supplements including consumers over age 65, aging Baby Boomers
Whether you are customizing an existing product or designing something completely new, a contract manufacturer of private label
dietary supplements will help you bring your unique vitamin or supplement to life.
Scientists, formulators and product development professionals turn your sports nutrition, vitamin, and health supplement ideas
into viable, stable & FDA compliant products in state-of-the-art facilities with stringent quality-controls that ensure
your finished product (capsules, powders, softgels, and super-popular gummies) satisfies your standards.
Sports Nutrition & Fitness
Your company manufactures or sells mainstream sports supplements for
baseball, basketball, football players
bodybuilding, or niche products for tennis players
with ingredients that support growth, power, endurance, energy, concentration and much more.
Most common sports supplements include
hormones / testosterone builders
Are you getting enough fiber?
Eat orange pulp
Leave the skin on
Eat your seeds
Stop eating white bread
Go for crunchy foods
Add cereal in more places
Eat less meat and more vegetables.
If you can’t bring yourself to get enough fiber into your diet, there are shakes, power bars and pills, as alternatives.
Choose a variety of nutrient-dense foods and beverages to help achieve recommended nutrient intakes. Foods like vegetables, fruits, whole grains, low-fat dairy products, and lean protein foods can help you get the nutrients you need without excess calories.
According to the CDC, a body mass index, or BMI, of 25 or higher is an indication that your weight may be unhealthy. And a waist circumference of over 40 inches in men and over 35 inches in women indicates excessive abdominal fat if BMI is 25 or higher.
Physical activity will always be a key component to moving toward a healthier weight.
What about Weight Loss Supplements?
Here are few popular ones :
Garcinia Cambogia Extract
Green Coffee Bean Extract
Green Tea Extract
Conjugated Linoleic Acid (CLA)
FDA laboratory tests have revealed the presence of
in weight loss products being sold over-the-counter.
Diet Plans : Do they actually work?
Ingredients in supplements to avoid
Because they have dangerous side effects such as rapid
heartbeat, liver damage and seizures :
Green tea extract powder
Red yeast rice
Ephedra (ma huang)
Stimulant laxative ingredients, like those found in dieter's teas
Aconite is used for inflammation, joint pain, wounds and gout. But it can cause nausea, vomiting, low blood pressure and heart rhythm disorders. It's been linked to respiratory system paralysis and death. Aconite is also known as aconite tuber, aconitum and radix aconite.
Bitter Orange is used for weight loss, allergies, and nasal congestion. But it's been linked to fainting, heart trouble, stroke and even death. Also known as aurantii fructus, Citrus aurantium and zhi shi, bitter orange contains synephrine, a compound similar to ephedrine, which the FDA banned.
Kava seems to be effective at treating anxiety, but it can cause liver damage. The FDA issued a warning. The remedy - also known as awa, Piper Methysticum and Kava-Kava is banned in Germany, Canada, and Switzerland.
Yohimbe is an herbal remedy used as an aphrodisiac, as well as a treatment for erectile dysfunction, chest pain, complications of diabetes and depression. It has been linked to high blood pressure, rapid heart rate and - when taken at high doses - severe low blood pressure, heart problems and even death. Yomhimbe, also known as Yohimbine, Corynanthe Yohimbi and Corynanthe Johimbi, may be unsafe to use without medical supervision, as it contains a compound that is actually sold as a prescription drug, Yohimbine. The FDA issued a warning about the risks.
Misbranded Dietary Supplements
Your dietary supplements products are misbranded because
■ the labels failed to indicate “Supplement Facts”
■ the labels failed to identify the product by using the term “dietary supplement” as a part of the product’s statement of identity
■ the serving size declared on each label (the maximum amount consumed per eating occasion as recommended on the product label), is incorrect
■ the serving size is not expressed in a common household measure - 1 teaspoon (5 ml), as an example
■ the labels failed to list the name and place of business of the manufacturer, packer, or distributor
■ the labels failed to declare the common or usual names of each ingredient used as required
■ the labels indicate a range for the serving size rather than the maximum amount recommended per eating occasion
■ the labels failed to declare the correct number of servings per container - The net weight (118 ml) divided by the serving size (5 ml) results in about 23 servings, but the label lists the servings per container as 6
■ the labels failed to indicate the source of the calcium
■ the labels failed to declare in supplement facts label section, an ingredient containing 2% or more of the RDI for that ingredient in the serving size
■ the labels list a %DV, but a Daily Value has not been established for that dietary ingredient
■ the labels failed to declare the %DV for zinc, magnesium, and selenium
■ the labels failed to list the dietary ingredients in the correct order
■ the labels failed to present the nutrition information in the correct format
■ the labels contain a nutrient content claim, but the product does not meet the requirements to make such a claim
■ the labels failed to identify the part of the plant (root, leaves) from which each botanical dietary ingredient in the product is derived, in English and not Latin
■ the labels misspelled ingredients
■ the labels declared an ingredient's flavor but failed to specify if the flavor is artificial or natural
■ the labels do not use the required term Daily Value (DV)
■ the labels failed to bear a symbol (e.g., an asterisk) in the column under the heading of "% Daily Value" that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement "Daily Value not established"
■ the labels failed to include the quantitative amount by weight per serving size of all the dietary ingredients
■ the labels fail to include a complete domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplements
■ the labels contain information in two languages, but do not repeat all the required information in both languages
■ the product is intended to be marketed “Weight Control Patches”, instead of for ingestion
Failure to promptly correct these violations may result in enforcement action by FDA without further notice, including seizure and injunction.