Sell your Dietary Supplements and Ingredients : Vitamins | Essential fatty acids (EFAs)| Branched-chain amino acids (BCAA)| Nutraceutical | Superfood | Fish Oil | Flaxseed | Omega-3 Fatty Acids | Weight Loss Conjugated Linoleic Acid (CLA) | Coenzyme Q10 (CoQ10) | Alpha-Lipoic Acid | Green Coffee

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What's included


Facility Registration

Domestic company

Foreign company

U.S. Agent Service | Foreign companies only


Fees

$99.00 USD | Initial Registration Fee

$99.00 USD | Annual Registration Fee

$99.00 USD | Same Day Service Fee

$99.00 USD | Certificate of Registration Fee

$99.00 USD | Biennial Registration Renewal Fee


GET YOUR FDA REGISTRATION NUMBER TODAY

Low Cost FDA Registration for Food Companies | Limited Offer only

Companies can export or import Dietary Supplements | Dietary Ingredients
to or from the United States as long as the facilities that produce, store, or otherwise handle the products are registered with the FDA (Food and Drug Administration), and prior notice of incoming shipments is provided to the FDA.


Americans spend about $2 billion a year on weight-loss dietary supplements in pill form
tablets
capsules
softgels.

Manufacturers market these products with various claims :
reduce macronutrient absorption, appetite
body fat, and weight and increase metabolism and thermogenesis.

The average product contains 10 different ingredients, but some contain as many as 96. Common ingredients include botanicals (herbs and other plant components), dietary fiber, and minerals.



REQUIRED INFORMATION


(*) Full company's name (as registered locally)

(*) Street address, city, postal / zip code, state, country

(*) Full name of CEO / Manager

(*) Telephone number of CEO / Manager

(*) Email of CEO / Manager

(*) Product details


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Payment methods accepted

PayPal, Local European Payments
Debit and Credit Cards
Electronic Invoice, Bank Wire




What is a Dietary Supplement?


  • FDA Registration of Dietary Ingredients Companies | www.m.itbhdg.com | www.itbhdg.com
  • FDA Registration of Dietary Supplements Companies | vitamins, minerals, amino acids | www.m.itbhdg.com
  • FDA Registration of Dietary Supplements Companies | pill, capsule, tablet, or liquid dietary supplements | www.m.itbhdg.com

As defined in the Dietary Supplement Health and Education Act, a dietary supplement is a product (other than tobacco) that :

is intended to supplement the diet

contains one or more dietary ingredients (including vitamins; minerals; herbs or other botanicals; amino acids; and other substances) or their constituents

is intended to be taken by mouth as a pill, capsule, tablet, or liquid; and

is labeled on the front panel as being a dietary supplement.


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LEGISLATION

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA) :

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."

New and Improved Nutrition Facts Label

New and Improved Nutrition Facts Label | www.m.itbhdg.com

The FDA’s revisions to its nutrition labeling requirements :

(1) 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

(2) amends certain serving size requirements. Same would apply to "Supplements Facts" of dietary supplements labels.

Manufacturers will need to use the new label by July 26, 2018, and small businesses will have an additional year to comply. During this transition time, you will see the current or the new label on products.

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Health Claims

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.

Accurate Labeling of Dietary Supplements

Manufacturers may make three types of claims for their dietary supplement products :

1. Health claims

2. Structure/function claims

3. Nutrient content claims

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.

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Dietary Supplements Market

The U.S. nutritional supplements market is going to maintain its average growth rate of over 6% per year hitting sales of $60 billion by 2021. Globally, the market is now valued at $82 billion.

More than half of Americans are taking supplements including consumers over age 65, aging Baby Boomers and adolescents.

The U.S. is the top market in value, followed by China, Japan, South Korea, Italy, Russia, Australia, Germany, Taiwan and Canada.

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Dietary Supplements Contract Manufacturing

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.

Production services include :

Capsules
Tablets
Powders
Softgels
Bottling
Film Coating
Powder Blending

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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
proteins
pre-workout formulas
creatine
hormones / testosterone builders
fatburners.




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
Try almonds
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.



Weight Management


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
Caffeine
Raspberry Ketones
Green Coffee Bean Extract
Glucomannan
Green Tea Extract
Conjugated Linoleic Acid (CLA)
Bitter Orange.


Diet Plans : Do they actually work?


Low-Carb Diet
Mediterranean Diet
Paleo Diet
Gluten-Free Diet

Ingredients in supplements to avoid


Because they have dangerous side effects such as rapid heartbeat, liver damage and seizures :

Aconite caffeine powder
Chaparral
Coltsfoot
Comfrey
Germander
Greater celandine
Green tea extract powder
Kava
Lobelia
Methylsynephrine
Pennyroyal oil
Red yeast rice
Usnic acid
Yohimbe
Aristolochia
Ephedra (ma huang)
L-tryptophan
Germanium
Magnolia-stephania
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.