Some basic facts you should know when you import dietary supplements from overseas

 

From the past …….

If you admire the liberal policies, which the US has adopted for the production and sale of food supplements and organic health products, then you probably know that this was not always the case!

In fact for a long time, the US Food and Drug Administration (FDA) enforced a very restrictive set of laws. The US citizens looked with envy toward good old Europe where such phyto-products were readily available.

The pharmaceutical companies were not interested in developing and manufacturing products, which could not be protected by patents. The patent approval process is expensive, and the costs could not easily be passed to consumers. In addition the restrictions on the manufacturing process for natural food extracts was prohibitive. Natural products were more expensive than the synthetic drugs and offered no legal protection for the large pharmaceutical companies. As a result the phyto-products were never made available to the consumers. Eventually, consumer protection groups started to put pressure on the members of Congress.

Changes were made 1994, when Congress created the Dietary Supplement Health and Education Act (DSHEA). Many obstacles in the FDA approval process were eliminated. The new law simplified the procedure to obtain market approval. The FDA only required a standard monochromatic material analysis test. The FDA also loosened its reigns on product declarations (e.g. "This product will help you loose 30 lbs in 30 days"). Since 1994, the FDA has concentrated mostly on preventing manufacturers from using false statements or outlandish claims to sell their product. The new law also removed the restriction that phyto-products could only be sold in a drugstore or pharmacy. Today supermarkets and specialty stores can sell these products too.

…… to the present

Today advertisements can discuss a product’s benefits, if such a claim can be scientifically substantiated. If a claim is only based on hearsay, the company must mention that the FDA has not reviewed the claim. Consequently the manufacturers very often print on the label, "This statement has not been evaluated by the FDA and this product is not intended to diagnose, treat, cure or prevent any diseases." It is left up to the consumer to be as educated as possible and discuss consumption of phyto-products with their licensed healthcare provider. This is especially important when such products are taken together with other medicines.

However, the manufacturer (domestic and offshore) of dietary supplements cannot bring a product to the US market without some inspection. The FDA routinely visits and inspects the production facilities for proper hygiene. The purity of natural substances is also evaluated. Similar rules apply to facilities, which handle food. The FDA will act very quickly if it receives consumer complaints or alerts from healthcare professionals. The stringent controls applied by the FDA for pharmaceuticals are not applied to the dietary supplement market.

The DSHEA of 1994 had very positive effects for the general public. A balanced or augmented diet with fewer vitamin and mineral deficits resulted. A wide spectrum of supplements reached the market, often replacing traditional and expensive prescription drugs for the educated consumer. During a time span of only two years, 20,000 new dietary products were introduced in the US, and more are offered every day.

….. as a result: lower prices and improved well-being

All these developments in the dietary supplement market generated competition and volume. As a result the consumer saw drastically lower prices. For example, the natural hormone DHEA (dehydroepiandrosteron) was not affordable until it received dietary supplement status. Prior to 1994 DHEA was sold only as a prescription drug. 90 pills (25mg) were sold for over $100.00. Today, the same amount costs only $25.00 without any reduction in quality.

In the US the consumers were the real winners. Sure the lower prices helped to make all these supplements more popular. But also the educated consumer became more willing and able to care for his or her own well-being. With phyto-products more readily available, consumers were able to take more responsibility for family health and prenatal care without being restricted by governmental rules and regulations every step of the way.

With the increase of new products on the market, there was a need for more information. Many books about dietary supplements are now available. Many magazines have special columns for their readers, and a slew of health letters and websites were created. This is what the lawmakers wanted to happen. Remember the "E" in the DSHEA of 1994 stands for "Education."

It is also the full intent of this website to make more information available to European consumers!