Understanding DSHEA: How it Shapes the Dietary Supplement Market

The Dietary Supplement Health and Education Act (DSHEA) is a pivotal piece of legislation that defines and regulates the dietary supplement industry in the United States. DSHEA aims to ensure that consumers have access to safe and properly labeled dietary supplements while providing the FDA with the authority to take action against unsafe or misbranded products after they reach the market. 

Since its passage in 1994, DHEA has had a profound impact on how dietary supplements are manufactured, marketed, and monitored. For distributors and manufacturers, understanding DSHEA is crucial. Complying with regulations not only helps avoid legal issues, but it also ensures the trust and safety of consumers, enhancing product credibility and marketability. 

Background: The Dietary Supplement Health and Education Act 

Dietary supplements in the United States first came into use in the 1930s and steadily grew in popularity until the 1980s, when the industry saw explosive growth. Before DSHEA, dietary supplements were often subject to the same rigorous approval process as pharmaceutical drugs, which many argued was inappropriate and overly restrictive. 

Passed in 1994, DSHEA was a response to the rapidly growing industry and the need for a regulatory framework that balanced consumer access with safety. When Congress passed this legislation, it determined the following: 

• Dietary supplements are helpful, widely used, and generally safe. 

• Consumers should receive accurate information about their supplements. 

• Reasonable legislation and oversight are necessary to ensure consumer safety.  

What does the Dietary Supplement Health and Education Act mandate? 

There are several key provisions outlined in DSHEA's text that establish dietary supplement industry standards. 

Definition of Dietary Supplements 

DSHEA defines dietary supplements as products taken orally that contain a "dietary ingredient" intended to supplement the diet. These dietary ingredients may include: 

• Vitamins 

• Minerals 

• Herbs or other botanicals 

• Amino acids 

• Enzymes 

• Organ tissues 

• Glandulars 

• Metabolites 

This broad definition covers a wide array of products, making it essential for manufacturers to understand what qualifies as a dietary supplement under DSHEA. 

Safety and Manufacturing Standards 

To ensure the safety and quality of dietary supplements, DSHEA authorized the FDA to establish Good Manufacturing Practices (GMPs). These practices ensure that products are consistently produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled.  

Though DSHEA was passed in 1994, supplement-specific GMPs were not announced until June 2007 and were not enforced until 2010. Presently, compliance with GMPs is mandatory, and the FDA conducts inspections to enforce these standards. 

Labeling Requirements 

Accurate labeling is a cornerstone of DSHEA, designed to inform and protect consumers. This requirement has two parts: what labels must say, and what they can and cannot say. 

What Labels Must Include 

 The law requires that dietary supplement labels include: 

• Product name 

• Statement of identity (what the product is) 

• Directions for use 

• Name and place of business of the manufacturer, packer, or distributor 

• A domestic address and/or phone number for reporting any adverse effects directly to the manufacturer 

• A list of “other” ingredients not mentioned in the “Supplement Facts” panel (i.e. stabilizers, color additives) 

• A “Supplement Facts” panel 

The “Supplement Facts” panel must list the serving size, servings per container, the name of each ingredient (except proprietary blends) and the quantity of each ingredient, listed as a percentage of Daily Value or amount by weight.  

What Labels Can and Cannot Say 

DSHEA allows dietary supplements to make claims about how the product affects the structure or function of the body. The three types of allowed claims include: 

• Health claims: “May reduce a woman's risk of having a child with a brain or spinal cord birth defect." 

• Nutrient content claims: “Excellent source of Vitamin B” 

• Structure/function claims: “Supports bone density” 

Supplements cannot claim to diagnose, cure, mitigate, treat or prevent disease without FDA approval. Allowable claims must be substantiated by evidence, and the label must include a disclaimer stating that the FDA has not evaluated the claim.  

New Dietary Ingredients (NDIs) 

At the time of DSHEA’s passage, the FDA advocated that dietary supplements should be regulated as food additives. However, the new law made it clear this would not be the case. Instead, DSHEA created two classifications for supplement ingredients: “old” or “grandfathered” ingredients and “new dietary ingredients.” 

All ingredients marketed and sold in the U.S. prior to DSHEA were grandfathered in and considered safe for use. For dietary ingredients not marketed in the United States before October 15, 1994, DSHEA requires a pre-market notification to the FDA.  

To submit a notification for an NDI, manufacturers must provide the FDA with evidence that the new dietary ingredient is reasonably expected to be safe under the conditions of its intended use. This notification must be submitted at least 75 days before the new ingredient hits the market. This helps ensure that new ingredients entering the market do not pose health risks to consumers. 

Regulation and Oversight 

DSHEA mandated the FDA to be responsible for regulating the safety and labeling of dietary supplements and removing unsafe products from the market. Meanwhile, the Federal Trade Commission (FTC) oversees the advertising of these products, ensuring that marketing claims are truthful and not misleading. 

Additionally, under DSHEA dietary supplements are regulated by the Food and Drug Administration (FDA) as a category of food, not as drugs. This means that dietary supplements do not need FDA approval before they are marketed. However, manufacturers are responsible for ensuring that their products are safe, that any claims made about them are substantiated by adequate evidence, and that the labels are truthful and not misleading.    

DSHEA implications for manufacturers and distributors 

Failure to maintain compliance with DSHEA regulations can come with serious consequences. If a violation is found, the FDA will usually send a warning letter or issue a 483 notice with the expectation that the manufacturer will correct the problem. This may come with several consequences: 

• Correcting some issues can be time consuming and expensive. In some cases, the supplement may have to be reformulated altogether.  

• All FDA warning letters and 583 notices are public record, which can impact consumer trust. 

• Class-action lawyers seek out these public records to formulate class-action lawsuits.  

If the problem remains unresolved, the FDA has the right to impose hefty fines or suspend manufacturing to ensure consumer safety. To maintain compliance with DSHEA regulations, manufacturers should scrutinize their performance in the following three areas: 

1. Compliance with GMPs and Quality Control 

Manufacturers must implement and adhere to GMPs, which include proper facility maintenance, equipment cleaning and rigorous testing of raw materials and finished products. This ensures product safety and consistency.  

Maintaining compliance requires creating a culture of workplace safety and quality. Employees should be regularly trained on GMPs with an emphasis on the importance of quality control. Internal audits should be conducted regularly and assessed to pinpoint areas for improvement. 

2. Marketing and Labeling Practices 

Accurate and truthful labeling is essential. Manufacturers must avoid making unsubstantiated health claims and ensure that all required information is present on the label. Labels should be triple-checked and run by multiple team experts for quality control.  

3. Risk Management 

Distributors and manufacturers must be vigilant about preventing adulteration (contamination or inclusion of unauthorized substances) and misbranding (false or misleading labeling). They should have robust systems in place for tracking and recalling products if issues arise, protecting both consumers and the business. Risk management should be part of employee training. 

Your Partner in DSHEA Compliance 

Understanding and complying with DSHEA is essential for anyone involved in the dietary supplement market. By ensuring the safety, quality and truthful labeling of dietary supplements, DSHEA helps protect consumers and maintain the integrity of the industry.  

For distributors and manufacturers, compliance is not just a legal obligation but a commitment to delivering safe and effective products to earn consumer trust. That’s why it’s critical to ensure compliance before the product enters the market. 

Palmer Holland is a one-stop shop for sales, marketing, and market intelligence expertise in the health and nutrition sector. Our customers can expect to receive increased technical knowledge accumulated through concentrated experiences as well as a higher level of product and application expertise from focused and specialized training in dietary supplement regulations. 

If you’re looking for a partner in maintaining DSHEA compliance for your dietary supplement product, look no further. Contact us today for more information on how we can work together.