FDA and Supplement Regulation 101

By: Katy Did Click author's name for more of his/her articles

The world of online purchasing can be tricky. There is sometimes a sense of concern when it comes to web purchases. You are paying for a product without touching it, seeing it or knowing the individual you are buying from. Part of this insecurity is rooted in irrational fear and part of it is rightly justified. The unpleasant truth is that there are people out there that will lie, cheat or misrepresent circumstance just to make a buck, so how do you become a more knowledgeable online shopper and consumer? How do you know that changes in labeling, appearance of a product or a formula are appropriate or not? Finding this information can sometimes be challenging, but it’s important to recognize that many changes are the character of government regulation.

First things first, manufacturers of dietary supplements and health and beauty goods are all regulated by the Food and Drug Administration (FDA). When it comes to labeling, manufactures are bound by FDA regulation to accurately represent substances on product labels. In fact, it is the objective of the manufacturer to ensure a products safety and provide the applicable information on labels before they can be sold in the United States. Just recently, regulations were finalized that will be changing the face (labels) of many dietary supplements over the next few years. A proposal made in 2003 for better regulations regarding manufacturer labeling, testing, quality control and dietary ingredients is now essential of all manufactures and enforcement will develop over the next three years as companies transition to meet the new mandatory requirements. Small manufacturer companies, with 20 or fewer employees, have until June 2010 to comply with new labeling regulations.

What does this mean for you as the consumer? It means that you can expect to see a few changes in the labeling on dietary supplements and merchandise that you have made a part of your routine and lifestyle. Manufacturers that have become common names in the supplement industry are making changes to their products packaging and appearance. Urban Nutrition, LLC has been a long follower of FDA regulations and GMP (good manufacturing procedures) guidelines. As a well known distributor of products like Belleplex, they have made a name in the supplement industry, providing customers products that impact and improve their lives.

Belleplex is a perfect example of a product that has seen some result revisions in its labeling. Longtime users of Belleplex were used to the list of common names for the ingredients. When new packaging emerged in late summer of 2009, customers were thrown off with what appeared to be a new list of ingredients on their favorite anti-wrinkle cream. The product’s ingredients hadn’t changed, but the names for the ingredients had. Natural products that are derived from plants have common names (those we use and are more easily pronounced) and scientific names, which are generally longer and more complex. The problem with showing common names on labels is that in some indications plants of different species could have the identical common name and more importantly, the scientific names offer universality. Scientific names areregularly derived from Latin roots, which means that the words are more universally recognizable. These changes help to establish quality and product expectations are a universal goal.

Manufacturers are held accountable to provide consumers with a essential amount of information on product labels. Some information that must be available includes a descriptive name for the product that states that it is a “supplement,” the name of the company and locale of the manufacture, packer or distributor, a complete list of ingredients and a “Supplements Facts” panel. Many online sellers are only resellers of products, meaning they purchase the items from the manufacture and then resell the products on their own websites. Resellers are not accountable for changes made to products or labeling; the manufactures are. Usually, the easiest way to confirm a change in the appearance of a product or in the label is to contact the manufacturer, especially since their company information is required to be shown on the label.

Another considerate change in the manufacturing and labeling of supplements has to do with expiration dates and manufacture dates. Recently regulations require that companies test each batch before issuing an expiration date. These new expiration date regulations are causing a lot of companies to reconsider providing expiration dates on products. The testing the FDA requires of products in order to print an expiration date are expensive and add to the manufacturing process. This new regulation has led to a shift of information manufacturers are providing. One company to shift from offering expiration dates to offering manufactured dates is dietary supplement distributor, Eyefive, inc. One successful Eyefive, inc. product is Breast Success, a dietary supplement that is intended to naturally increase breast size, has recently changed packaging and now only offers a manufactured on date, no expiration date. From a business standpoint, following through with new and costly testing for each assembly of product to only offer an estimated expiration date seems imprudent when you can provide consumers with the manufactured date instead. Companies, like Eyefive, guarantee that a product will be good 2 years past the manufacturing date.

What about changes to the color, shape or size of pills? Sometimes manufacturers potentiality may change inactive ingredients in pills, such as dyes and coloring, which will change the appearance of dietary supplements. Changes to inactive ingredients can create variations from one batch to another. Companies must note any ingredient changes that affect the pills formula on the label, but changes to products that do not control effectiveness or strength can occur without information. Again, this is where contacting the manufacturer may be the appropriate choice in determining if the supplement is real and authentic.

Online outlets such as Amazon and Ebay are supplied by a variety of resellers. These resellers are often uninformed of manufacturer changes and are not responsible for relaying this information to customers. While it may appear ingrained to credit the worse of a website or reseller, it’s important to note that like you, they trust that the manufacturer is making changes in compliance with FDA regulations and requirements. regularly these changes go unannounced and completely new products and labels end up on the shelves without warning or pre-notification to buyers and consumers. If in doubt, call a company and ask. They are entirely the only ones that can explain the changes they have made or know the ingredients and why they were selected for blends.

While government regulation exists to serve the people, it’s generally the unannounced and unnoticed branch of the consumer’s world. They exist to ensure safety, quality and health standards, fundamentally working for the enhanced good to a consumer driven economy and world.

For additional information about FDA regulations and changes in the dietary supplements you can see the links in our blog.

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