Are Nutritional Supplements Regulated in a Different Way from Food and Drugs?

The justified answer is ‘YES’, though nutritional supplements are regulated by the FDA as foods, they are regulating in a different way from other foods and drugs. Most of the time, categorization as a nutritional supplement is defined by the information that the producer provides on the product’s label or in supplementary literature, even though many foods and nutritional supplementary product’s labels do not include this kind of information. Whether a product is categorized as a nutritional supplement, usual food or drug is based on its intended use.

How the intended use of a product is established?

According to the statement tagged on the product labeling, in advertising, on the Internet, or in other promotional supplies. There are certain claims which may cause a product to be considered as a drug or medicine, even if the product is marketed as if it were a cosmetic or usual product. Those types of claims establish the product as a drug or medicine because the intended usage is to treat or prevent diseases or affect the formation or functions of our human body. The label tagged on a nutritional supplement or food product may include one of three types of claims: 

1. Health Claim: Illustrates an affiliation between a food/food component or nutritional supplement component and reducing the risk of disease or health related condition.
2. Nutrient Content Claim: Illustrates the related amount of a nutrient or food material in a product.
3. Function/Structure Claim: It is a statement describing how a product may affect the systems of our body and it cannot explain any exact disease. (E.g. glucosamine helps to hold up healthy joints). Function claims do not need FDA approval but the producer must provide FDA with the copy of the claim within 30 days of putting the product on the market Product labels holding such claims have to comprise a disclaimer that reads, “This statement is not evaluated by the FDA. This product is not intended to treat, diagnose, prevent or cure any disease.” Any other health related claims are habitually about marketing, not about health. Just keep in mind that foods are not drugs! Here are some key regulation differences between Supplements & Cosmetics and Drugs & Medicines.

Drug is only a chemical essence in a medicine that alters the function of some of the body’s biological progressions. But medicine is drug (Combination of drugs) which is intended to prevent illness or cure diseases and give relieve from pain.

When company seeks approval to sell a drug then it is needed to test their products in a laboratory and with animal tests to explore how the drug works and whether it’s safe to consume and can work well in humans. Then, a succession of tests in humans is started to decide whether the drug is safe when used to treat a disease and whether it delivers a real health benefit to our body.

Nutritional Supplements are regulated by the FDA with a type of “Recipe Book” covering satisfactory components, doses, formulations, and labeling. Products in compliance to this may be marketed without added FDA permission.

Nutritional Supplements and medicines passed through different monitoring requirements set forward by the FDA. Supplements, like Omega-3 fatty acid supplements, are categorized as a “food” by the FDA. That means it is the producer’s liability to make sure that the supplements are safe, free from contamination, properly labeled, and made in a secure and hygienic environment.

Prescription medicines by the doctors, on the other hand, are monitored through a little bit different way. For example, prescription Omega-3 fatty acids must pass through under broad testing before they can be distributed in pharmacies. The producers must be proved by the FDA that the distributed drug works how it is supposed to, also that it is safe and any unfavorable effects of the drug, and that it encloses all of the components explained on the product label.

In a nutshell it can be said that-

Drugs Meant To:

• Suggested by a doctor or medical practitioner.
• Bought at an authorized pharmacy shop.
• Suggested for and intended to be used by the experienced person.
• Drug producers may claim that their product will analyze, heal, ease, treat, or prevent a disease.

Supplements Meant To:

• Foods which do NOT need a doctor’s prescription or suggestion.
• Simply available to the public.
• Medical statement may not legally be made for nutritional supplements. 

The challenges which a company like us- Forever Living Products faces everyday are the risk of distributors crossing the Fine Line. We cannot under estimate the consequences of the result it will have on you as a distributor as well as on the company. The main problem in developing countries is that Nutritional Supplements are not ruled by an exact law at the moment.

ForeverLiving Products distributors and consumers can be assured that the products are tested and certified as fit for sale before they are permitted to distribute around the world. We are not only complying with the obligatory checks at the custom level but also we choose and perform random product tests for our own records and satisfaction. That is the promise of Forever Living!