How Are Dietary Supplements Regulated?

by Emily Macadam on May 06, 2020

Is it a Food? Is it a Drug?

Neither food nor drugs, dietary supplements fall under the umbrella of food products but into their own unique category. Defined by the Food and Drug Administration as “a product taken by mouth that contains a ‘dietary ingredient’ intended to supplement the diet,” a dietary supplement may contain “vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites.” They may come in the form of extracts, concentrates, “tablets, capsules, softgels, gelcaps, liquids, or powders.”1

In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA), which created a framework for regulating supplements and a system of penalization for noncompliant supplement manufacturers, and set unique standards for the regulation of dietary supplements.

The Approval Process 

Conventional food items don’t have to be approved by the FDA. While drugs are generally considered unsafe by the FDA until clinical trials have proven their safety and efficacy, dietary supplements are generally considered safe until proven unsafe. They cannot, however, “contain anything that may have a ‘significant or unreasonable risk of injury’ when the supplement is used as directed on the label.”5

Manufacturers are largely responsible for “determining that the dietary supplements [they] manufacture or distribute are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading.”1 In 2007, the FDA published a list of current Good Manufacturing Practices (cGMP) that “ensure the identity, purity, quality, strength, and composition of dietary supplements” and also include requirements for “sanitary practices, proper training of personnel, cleaning of equipment and in-process controls to ensure consistency.”1,2

The FDA also provides regulations regarding the information a dietary supplement label must include. Every supplement must be marked with “a descriptive name of the product stating that it is a ‘supplement;’ the name and place of business of the manufacturer, packer, or distributor; a complete list of ingredients; and the net contents of the product” as well as a nutrition label “in the form of a ‘Supplement Facts’ panel.”1

What Claims Can Dietary Supplements Make?

Dietary supplement manufacturers can make limited claims about the use and benefits of their products. No product can claim to treat, prevent, or cure a specific disease or condition, as those kinds of statements require clinical testing to validate. The claims that dietary supplement manufacturers can safely make fall into four categories: “nutrient content claims, nutrient deficiency claims, structure/function claims, and health claims.”3 To make a structure/function claim, which describes a nutrient or ingredient’s role in a structure or function of the human body, a manufacturer must notify the FDA of the use of the claim within the first 30 days of marketing the product. The FDA must approve any health claims before a dietary supplement goes to market.

How Effective Is The System? 

The Food Safety Modernization Act (FSMA), signed into law in 2011, provides the FDA with “new enforcement authorities designed to achieve higher rates of compliance with prevention- and risk-based food safety standards.”2 Standardized cGMPs give the FDA a basis by which to “deem any dietary supplement that ‘has been prepared, packed, or held under conditions that do not meet good manufacturing practice regulations’ to be adulterated.”4

The FDA also has the prerogative to recall and/or detail any dietary supplement products that can reasonably be suspected to cause serious adverse effects, and manufacturers are required to report any such incidents to the administration.

Because there are thousands of independent supplement manufacturers throughout the United States, however, it’s impossible for the FDA to ensure compliance with cGMPs across the board. In 1994, the dietary supplement market was worth an estimated $4 billion in the United States. Today, that number is estimated by the Nutrition Business Journal to have reached over $46 billion.4 

FDA regulations don’t extend to research and development, marketing, or any company department not related to the efficacy and quality of the finished product, though the Federal Trade Commission “regulates dietary supplement advertising [by the same standards] as it does for all consumer products by enforcing truth-in-advertising laws.”6

Because the FDA does not verify the contents of dietary supplements or the percentages of ingredients they are purported to contain, discoveries like the following are not unheard of:

In 2013 researchers in Toronto published a report in which they sampled and analyzed 44 herbal supplements. The supplements were...labeled as containing single herbs. Using DNA barcoding analysis, less than half of the supplements (48%) contained any of the herb listed on the label. More than half of the supplements contained something that wasn’t on the label (substitutions or fillers). Even among the samples that contained the herb on the label, many also contained fillers or contaminants.8

Other problems plaguing the dietary supplement industry include supplements that are tainted, don’t contain the ingredients listed on the label, contain amounts of ingredients that deviate from the listed percentages, or include unlisted ingredients. Some supplements marketed as “natural” or “herbal” aids actually contain prescription drugs, banned substances, or untested ingredients.

It’s important, then, for those who intend to consume supplements to follow good purchasing practices and educate themselves on the potential risks of supplementation, especially if they also take prescription drugs or medications

The USDC Difference

Despite the potential for interaction with supplements that are mislabeled, tainted, or unsafe, the Council for Responsible Nutrition found that 77% of Americans age 18 and older took dietary supplements in 2019. These survey results indicate “strong consumer confidence and trust in dietary supplements and the dietary supplement industry…[given its] success in bringing to market safe, high-quality dietary supplement products.”9 While some companies do continue to sell subpar supplements, other companies strive to build their reputations on their commitment to quality, efficacy, reliability, and innovation.

U.S. Doctors’ Clinical is one such company. We employ self-regulation strategies to ensure adherence to the most rigorous of standards. Every step of our process is monitored for compliance with strict legal, ethical, and safety standards; audited by independent quality control organizations including NPA, NSF, and UL; and carefully documented in accordance with DSHEA and FSMA requirements.

 But we don’t stop there.

U.S. Doctors’ Clinical assembled an Advisory Board of over 40 physicians and healthcare practitioners to guide the development, testing, and review of each one of our formulas. These medical professionals possess a wealth of expertise that provides the foundation for targeted, scientifically backed formulas that deliver real, measurable results.

Our experts don’t just advise on our products—they routinely recommend them to their own patients. That’s because the U.S. Doctors’ Clinical logo isn’t just a brand name. It’s a promise that all of our supplements are made with premium-sourced ingredients for maximum purity, efficacy, and peace of mind.

Since day one, we’ve had a single focus: provide high-quality, clinically proven products that nourish your body and help you reach your health and vitality goals.

You work hard to stay healthy. Choose U.S. Doctors’ Clinical for tried-and-true supplements that deliver real benefits.

Click & use code TRUST to get your first month's product subscription ABSOLUTELY FREE 

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