Does the EU Regulate Supplements Better than the U.S.?

Dietary supplements marketed in the United States take a different path to land on store shelves than those in the European Union. To sort out these differences, Healthnews takes a closer look at the regulatory processes of both regions to determine which approach might be better for consumers.

In the quest for optimal health and wellbeing, many people turn to supplements to help maximize their chances of living a long health span. Luckily, there are many products to choose from depending on a person's ultimate health goal.

For instance, some supplements claim to ease long COVID symptoms, boost brain function, and promote longevity.

However, it's buyer beware in the dietary supplement world, as some products might not contain the ingredients printed on the label or have undeclared components that may be potentially harmful.

For example, the FDA has issued warnings on bodybuilding supplements containing steroid-mimicking compounds. The agency has also issued alerts on products that claim to help with weight loss because they contain hidden ingredients that could pose a health risk.

Also, some just don't work. For instance, reports suggest that some dietary supplements claiming to lower cholesterol are ineffective.

These issues are why regulatory agencies oversee dietary supplement products. However, how the U.S. handles this differs significantly from the EU.

But what are these differences? And is one regulatory approach better for consumers?

Supplements in Europe vs. the U.S.

Dietary supplements are classified and regulated as foods in the EU. In addition, supplement manufacturers must go through a rigorous pre-market approval process and provide scientific evidence demonstrating the safety and nutritional value of their products.

Moreover, regulations are consistent across member states. For example, the European Commission sets general rules, and each member state enforces them. The EU also regulates labeling requirements and the maximum levels of vitamins and minerals permitted in supplements.

However, in the U.S., dietary supplements are treated as a separate category under the Dietary Supplement Health and Education Act (DSHEA) of 1994 and do not require pre-market approval by the FDA. Instead, manufacturers are responsible for ensuring the safety and compliance of their supplements.

Still, if the manufacturer wishes to market a new ingredient, they must submit a New Dietary Ingredient (NDI) Notification to the FDA. However, this is merely a notification and is not subject to approval.

In addition, the FDA prohibits companies from marketing misbranded or adulterated products. The agency also periodically inspects dietary supplement manufacturing facilities, reviews labeling information, and monitors adverse event reports after the product enters the market.

But the FDA doesn't determine ingredients unsafe or require companies to remove them from the market until they discover a product is misbranded or adulterated, doesn't comply with the laws, or adverse health events occurred in people using the product.

In the EU, the European Food Safety Authority (EFSA) authorizes all health claims made on supplement labels. Conversely, in the U.S., supplement manufacturers can make general claims about supporting normal bodily functions but cannot make specific claims about treating or preventing disease.

Moreover, supplement labels in the EU must include information about recommended daily intake, a warning not to exceed the stated dose, and a statement that the product should not substitute a varied diet.

Labeling protocols are similar in the U.S., as supplement labels must indicate that the product is a dietary supplement, list the ingredients, provide the quantity of contents, display the manufacturer's information, and offer suggested use directions. Additionally, a disclaimer must state that the FDA has not evaluated the product.

Is one strategy better than the other?

The regulatory process in the EU is much more proactive, meaning the supplement must be proven safe and effective before being sold. In contrast, the U.S. monitors supplements to some degree, but only after the product hits the market.

Moreover, the FDA intervenes only after a product's safety is questioned, or the manufacturer violates the agency's rules.

"The differing regulatory approaches in the U.S. and the EU have their respective pros and cons," says Isaac Robertson, co-founder of Total Shape, a health and fitness company.

Robertson explains that the regulatory framework in the U.S. allows supplement manufacturers to enter their products into the market faster, providing consumers with a wide range of choices. This framework also encourages manufacturers to create innovative products."

"On the other hand, the EU's stricter regulations ensure a higher level of safety and quality control," Robertson adds. "The pre-market approval process, scientific substantiation of health claims, and maximum levels for vitamins and minerals help protect consumers from potentially harmful or ineffective products."

The EU uses an approach that utilizes real and scientifically reliable evidence.

Robertson explains that whether one regulatory approach is better for consumers is subjective and depends on various factors. Though the U.S. approach allows for a broader selection of supplements, potentially giving consumers more choices and access to innovative products, it places more responsibility on consumers to research the supplements they choose.

In contrast, Robertson points out that the EU approach, with its stricter regulations and pre-market approval process, provides a higher level of assurance regarding the safety and efficacy of supplements. However, the EU's regulatory framework may lead to a more limited selection of products, potentially reducing consumer choice.

"Ultimately, the effectiveness of a regulatory approach depends on the balance between consumer protection and the promotion of innovation in the supplement industry," Robertson says. "Both the U.S. and the EU aim to ensure the safety and quality of supplements, albeit through different means."

So, when choosing supplements, Robertson suggests "consumers should carefully evaluate their individual needs, consult healthcare professionals, and consider reputable brands to make informed decisions about their supplement use, regardless of the regulatory environment."