Dietary Supplement Regulation in the United States

Success or failure in the proper manufacturing and distribution of Dietary Supplements in the United States depends on a variety of factors. Things such as formulation, good manufacturing practices, facility registration , product labeling and marketing, and product claims are all important factors that affect both the speed to market and success rate for your product. While the Dietary Supplement industry continues to expand, FDA is dedicating more time and resources to regulating it to verify compliance with the complex rules, regulations and requirements. According to FDA’s own published compliance programs, analyzing the compliance of Dietary Supplements’ labels is an emerging priority and growing in importance each month.

Common Challenges with Supplements

Dietary Supplement manufacturers and importers face various challenges depending on their degree of involvement and length of time in the business. Experienced manufacturers are struggling to stay on top of emerging trends and legislation but often have a good track record or “know the ropes” about just how much is required to successfully bring a Dietary Supplement to market. New Dietary Supplement companies or startups on the other hand are often on a tight budget, are learning as they go or are lacking sufficient staff/expertise to make strategic legal and regulatory decisions. The challenge for experienced companies is staying current and not relying on luck; the challenge for newer companies is to invest in preventative maintenance up-front. Many Dietary Supplement producers run into trouble with FDA when they least expect it. They may have had many successful imported shipments but suddenly find themselves with an FDA import detention, FDA refusal or warning letter. This could result from a false assumption that just because they have not had any trouble in the past that it meant they were doing it right. Also, new trends in food safety and legislation can bring a more watchful eye or hands-on approach from FDA. Remember, your product can be detained or flagged even if there is the appearance of a safety violation. Many times there isn’t an issue, just the appearance of one. Both will cost you money. That’s why it’s best to create the best possible label before you ship. The more roadblocks you avoid, the better.

Labeling Requirements

Did you know that Dietary Supplements are actually considered a “food” by the U.S. FDA? That’s right; you are technically selling a food, not a drug to American consumers. So what do you do with your Supplement Facts panel? Statement of Identity? Structure or Function Claims? FDA regulation is complex, ever-changing and often unclear. Labeling requirements for Dietary Supplements require a special Supplement Facts panel- do you know the difference between that and the standard “Nutrition Facts Panel?” What kind of claims are you permitted under the law to make? If a product is for weight-loss, do you know how to correctly communicate its intended function? If your supplement claims to “improve blood pressure” your product WILL BE red-flagged by the FDA and stopped. Weight-loss claims, health claims, “all-natural” and “organic” claims are all be carefully examined by FDA against the current regulation for supplements. In fact, FDA and the FTC (Federal Trade Commission) will examine your website in accordance with the Dietary Supplement Health and Education Act of 1994. Even if your product is revolutionary and perfectly safe, you might never get it to market unless you have your label and packaging in compliance with FDA regulation.

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