How Supplements Are Regulated in the USA and the EU

How Supplements Are Regulated in the USA and the EU

Food supplements are concentrated sources of nutrients or other substances with a nutritional or physiological effect, whose purpose is to supplement the normal diet. Food supplements are marketed ‘in dose’ form, for example as pills, tablets, capsules or liquids in measured doses etc. Supplements may be used to correct nutritional deficiencies or maintain an adequate intake of certain nutrients. However, in some cases excessive intake of vitamins and minerals may be harmful or cause unwanted side effects; therefore, maximum levels are necessary to ensure their safe use in food supplements.

Just because an over-the-counter product is called a dietary supplement doesn’t mean that it’s harmless.Quite a few supplements have been found to include hidden and potentially risky ingredients, including drugs.

In the U.S., the dietary supplement industry is a $32 billion industry. Dietary supplement products include vitamins, minerals, botanicals, sports nutrition supplements, weight management products and specialty supplements. These products are intended to be used as supplements to, not substitutes for, a well-balanced diet and a healthy lifestyle. When used properly, they help promote overall good health and prevent disease. More than 150 million Americans take dietary supplements annually.

How Supplements Are Regulated in the USA and the EUIn the United States, dietary supplements are regulated by the U.S. Food and Drug Administration (FDA). The FDA regulates dietary supplement marketing, ingredient safety and manufacturing. The industry itself has established several third party organizations that independently monitor and verify product quality. Many of these programs exceed FDA standards for dietary supplements.

Food and drugs – at first glance they seem worlds apart but upon closer inspection their boundaries start to merge. For decades, Congress and the Food and Drug Administration (“FDA”) struggled to define such boundaries until they finally created an intermediate product group called dietary supplements. The Dietary Supplement Health and Education Act of 1994 (“DSHEA”) established the statutory category of dietary supplements and subjected them to various food standards as well as a host of new standards. The DSHEA attempted to strike a balance between foods that are functional in that they have some health benefits and drugs that have clearly defined and approved health benefits. Since passage of the DSHEA, Congress, the FDA, and the dietary supplement industry have strove, with varying degrees of success, to implement the DSHEA and give definition to the ever expanding and extremely popular dietary supplement market.

Dietary supplements have always been regulated as a category of food in this country, and DSHEA did not change that fact. Virtually all facets of dietary supplement manufacturing, labeling and marketing are covered by extensive regulations issued and enforced by FDA and FTC. If dietary supplements were regulated like drugs, there would likely be no dietary supplement industry and the products that did exist would cost what drugs cost.

More recent regulations require manufacturers to observe good manufacturing practices (GMPs) established for this industry, including ingredient testing.

In contrast to prescription and over-the-counter drugs, dietary supplements covered by this act do not normally need approval from the U.S. Food and Drug Administration (FDA) prior to being marketed. The main exception is for products introducing a new dietary ingredient, where pre-market review for safety data and other information is required.

How The FDA Regulates Dietary Supplements

The U.S. Food and Drug Administration (FDA) regulates dietary supplements in several ways:

  • The FDA monitors the marketing claims made by dietary supplement companies. They make sure dietary supplement companies do not claim their products prevent, reduce the symptoms of, or cure diseases.
  • The FDA reviews and approves the introduction of new ingredients to the market by affirming generally recognized as safe (GRAS) status, or as new dietary ingredients (NDI).
  • If evidence indicates an ingredient is harmful, the FDA establishes supplement label warning requirements and – if necessary – mandates removal of an ingredient from the marketplace.
  • The FDA inspects manufacturing facilities to make sure they follow Good Manufacturing Practices (GMPs).
  • The FDA’s GMPs cover everything from raw material verification to finished product testing and accurate labeling.

When it comes to ensuring safety, effectiveness and quality, GMPs are perhaps one of the most critical areas of regulation.

How The FDA’s Good Manufacturing Practices Help Regulate Quality and Safety

FDA’s Good Manufacturing PracticesThe FDA has established different sets of GMPs for pharmaceutical products, medical devices, and foods. However, it took over a decade after legislation mandated it for the FDA to establish GMPs for dietary supplements.

It’s important to understand, while the FDA expects manufacturers of dietary supplements to comply with GMPs, the FDA does not certify companies to be in compliance. Instead, when the FDA inspects a manufacturing facility, it will issue “observations,” identifying deficiencies. The manufacturer then needs to correct these deficiencies.

The FDA has made some efforts to crack down on manufacturers and to increase consumer awareness of the potential risks of using supplements made outside the U.S or EU . But potentially harmful supplements continue to be found on the market.

“From a public health point of view, I think it’s really important that an effective strategy comes into place that protects the public,” says Dr. Ziv Harel, an internist at St. Michael’s Hospital in Toronto. “Scientific evidence should demonstrate that dietary supplements are safe prior to them being marketed to the population.”

In the European Union (EU)

In an effort to harmonize the internal EU market for food supplements and similar products the European Union has adopted some key pieces of legislation. In the European Union (EU), the vitamins and dietary supplements market totaled nearly €7
billion, food supplement products containing vitamins and minerals have a 50% share of the market.

The European Commission has established harmonised rules to help ensure that food supplements are safe and properly labelled. In the EU, food supplements are regulated as foods and the legislation focuses on vitamins and minerals used as ingredients of food supplements.

Until relatively recently, the market for vitamins and dietary supplements was underdeveloped in Eastern Europe but in the last couple of years, the demand for these products has grown very quickly, due to increasing disposable income of Eastern European countries and their growing concern for a healthy lifestyle and illness prevention.
The channels for distribution vary by country, with the majority of sales occurring in pharmacies. In the UK market, grocery stores and pharmacy chains are prevalent, while independent pharmacies dominate the markets in France, Germany, Denmark and Italy. Some other retail outlets including supermarkets are beginning to be developed in some countries such as Italy. Drugstores are gaining ground in countries such as Austria. Health food stores are also becoming more popular for example in Denmark.

European Directive 2002/46/EC (Food Supplements Directive or FSD) relating to food supplements was adopted on June 10, 2002, by the European Parliament and the Council. The directive establishes harmonized rules for the labeling of food supplements and introduces specific rules on vitamins and minerals in food supplements.

The scope of the FSD includes vitamins and minerals. Rules for nutrients other than vitamins and minerals should be developed in the future and for now are governed by Member State legislation.

The Directive establishes a positive list of allowable vitamins and minerals and their associated forms to be included in food supplements.

A very important piece of legislation for the food supplements sector is the regulation on nutrition and health claims Regulation 1924/2006 which sets EU-wide conditions for the use of nutrition and health claims.
A nutritional claim suggests a food has beneficial nutritional properties, such as “low fat”, “no added sugar” and “high in fiber”. A health claim is a statement that suggests a relationship between food and health for instance that a food can “help lower cholesterol”, “help reinforce the body‟s natural defenses” or “enhance learning ability”.

The regulation applies to any food or drink product produced for human consumption that is marketed on the EU market.
Nutrition and health claims will only be allowed on food labels if they are included in one of the EU positive lists. Food products carrying claims must comply with the provisions of nutritional labeling directive 90/496/EC

Nutrition claims referring to the reduction of fat, saturated fatty acids, trans-fatty acids, sugars and salt/sodium have been adopted and are listed in the Commission’s register.

Although B-Nergetics supplements currently retail only in the United States and Canada, company’s plans to go global were made with all these regulations in mind.

All B-Nergetics products are Manufactured in the USA in a GMP (Good Manufacturing Practice – Consistant Quality) and FDA (Food and Drug Administration) registered facility ensuring only the highest quality ingredients and comply with all US and EU regulations.


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