How the US keeps herbal dietary supplements safe


Every year, nearly 200 million of America's healthiest people use dietary supplements to support and maintain their health and well-being

The overall safety and efficacy of supplements sold in the US is ensured through a strong and complex framework of federal regulations, industry adopted best practices and the inherent safety of ingredients used in supplement.

The US regulates dietary supplements through host of federal laws and regulations that mandate supplements are safe, manufactured in a manner that ensures quality, accurately labelled, marketed with accurate information, and do not contain contaminants or impurities.

These laws and regulations are enforced by many federal agencies, including the Food and Drug Administration (FDA), Federal Trade Commission (FTC), US Department of Agriculture (USDA), and Environmental Protection Agency (EPA), among others.

In addition to federal requirements, the regulated supplement industry has voluntarily adopted numerous best-practices as part of its long tradition of self-regulation. The industry continues to develop and adopt policies and resources to address emerging issues and to maintain consumers' informed access to high-quality and safe supplements.

Manufacturing requirements

US supplement regulations created under the federal Food, Drug and Cosmetic Act (FD&C Act) require dietary supplements to be manufactured, packed, labelled and held in accordance to current good manufacturing practice (cGMP). The cGMP regulations require manufacturers to verify the identity, purity, strength and composition of their dietary supplements.

Supplement companies are also required to register manufacturing facilities with the FDA, and FDA regularly inspects facilities. Current law provides FDA with authority to take enforcement action against companies that don't comply with cGMP requirements. Enforcement actions range from warnings and recalls to Consent Decrees (that require facilities to close and FDA permission to reopen) and criminal charges depending on the severity of FDA inspectors' observations.

If a dietary supplement contains contaminants or does not contain the dietary ingredients on the label, FDA considers the product to be adulterated or misbranded. FDA has authority to remove adulterated and misbranded products from the market and take enforcement actions against anyone selling these products. Voluntary recalls by responsible manufacturers or distributors are the most common outcome.

Supplement ingredients

Federal law defines what ingredients dietary supplements may contain. This includes vitamins, minerals, herbs and botanicals, amino acids and other dietary substances used to supplement the diet. Supplements made from ingredients that fit the definition in the law and with a history of safe use prior to October 1994 can be used without notifying the FDA prior to use.

Premarket notification of safety data and other information is required for any supplement that contains ingredients that don't meet this definition and that the law classifies as New Dietary Ingredients (NDIs).

Pharmaceutical ingredients are not dietary ingredients and any product that contains a pharmaceutical does not meet the federal definition of a dietary supplement. Products that contain pharmaceuticals are drugs and are only legal if FDA has approved the product.

If unapproved, the product is a misbranded and adulterated drug. Regulatory agencies in the United States, Canada, Europe and Asia actively work to protect consumers from misbranded drugs and prosecute the criminals that sell them. The supplement industry strongly supports efforts to remove adulterated and misbranded products from the marketplace.

Labelling and marketing claims

Both FDA and FTC have authority over the marketing claims used to advertise supplements. Companies are forbidden from making claims that supplements can diagnose, mitigate, treat, cure or prevent diseases.

Supplement marketing is limited to health claims (describing a relationship between a dietary supplement ingredient and reduced risk of a disease or health-related condition), nutrient content claims (characterising the level of a nutrient in an ingredient), and structure/function claims (describing the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body).

Manufacturers submit a notification with the text of their claims to FDA and must state that the claims are substantiated.

Dietary supplement labels are required to identify all ingredients in the product and include Supplement Facts, which lists the names and quantities of dietary ingredients in the product. These labels must also include the name and address of manufacturer or distributor and all information that is "material in light of … claims … and the consequences that may result from … use."

Adverse events

Supplement companies and distributors are required by law to submit to FDA all serious adverse event reports received related to use of the dietary supplement. This is the same system that is used for over the counter drugs and the supplement industry advocated for this requirement to be added to the FD&C Act.

Serious adverse events associated with supplements are relatively rare given that roughly 166 million Americans use supplements each year according to the Center for Disease Control (CDC).

Industry self-regulation

Self-regulation is an integral part of the herbal supplement industry's history. The industry has created and implemented best practices and resources to ensure consumers have informed access to high-quality products. The industry also continuously innovates and adopts the latest technology to ensure quality and safety.

The American Herbal Product Association (AHPA), the professional association for the herbal supplement industry, requires members to comply with a Code of Ethics & Business Practices, which includes nearly 20 trade requirements that have been adopted and instituted over the last 3 decades.

These requirements range from labelling on products intended for use during pregnancy or nursing that instruct consumers to consult with a healthcare practitioner before using to cautionary information on the labels of products with high levels of added caffeine.

In addition, AHPA develops guidance policies to promote the responsible commerce of herbal products. These policies address a variety of labeling and manufacturing issues and reflect the consensus of AHPA's members.

These policies include a recommendation that consumers inform their healthcare provider of supplement use and industry take appropriate steps to assure that raw materials used to make herbal supplements are free of common adulterants. AHPA encourages its members and nonmember companies to adopt each of these policies in the interest of establishing consistent and informed industry practices.

Meeting emerging challenges

As the use of herbal supplements grows in popularity and companies increasingly source ingredients and sell products internationally, new challenges and opportunities are emerging. The US federal government and the regulated supplement industry continue to adopt additional rules, regulations and best practices to leverage new technology and meet the challenges of increasingly global supply chains.

FDA is also busy implementing the Food Safety and Modernisation Act (FSMA), the most sweeping reform of US food safety laws in more than 70 years, designed to ensure the US food supply is safe by shifting the focus from responding to contamination to preventing it.

This law will impact many herbal dietary supplement ingredient suppliers and is a new tool that will help supplement companies ensure quality and safety.

AHPA continues its self-regulatory tradition by recently updating guidance on good agricultural and collection practice and expands that guidance to address good manufacturing practice for ingredient suppliers throughout the botanical supply chain. This guidance will help the industry ensure quality and safety from seed to shelf.