The definitions of dietary supplements and alternative medicines from the perspective of the U.S. Food and Drug Administration (FDA) are as follows:

Dietary Supplements These are products that help supplement essential nutrients (vitamins, minerals, co-enzymes, enzymes, carbohydrates, fats, proteins, etc.) required for maintaining a healthy life, which cannot be adequately consumed through daily meals.

Alternative Medicines These refer to medicinal products that deliver active components scientifically proven in terms of their chemical structure and mechanism within the human body. These products are designed to alleviate symptoms or address the causes of specific diseases without requiring a doctor’s prescription. They often involve combining multiple active ingredients with chemical structures to create a synergistic effect. Most active components are extracted from herbs that have been used for centuries or even millennia.

The FDA does not distinctly categorize or label products as dietary supplements or alternative medicines. All such products must display the disclaimer: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” It is also prohibited to mention specific diseases on advertisements or product packaging, and using the term “FDA” for commercial advertising purposes is illegal. The FDA strictly enforces actions against such violations.

Koreans often ask certain questions when encountering new dietary supplements or alternative medicines: “Does this product have FDA (U.S. Food and Drug Administration) approval?” “Does it have clinical trial results?” And finally: “Products imported from Korea have FDA approval certificates. Does this one have something like that?”

These are, frankly, foolish questions that evoke laughter. Readers of this text should refrain from asking such questions in the future. Asking these questions amounts to a self-confession: “I don’t know much about the FDA, but I’m trying to sound knowledgeable.” It is especially disheartening to receive such questions even from practicing doctors and pharmacists. As someone who has worked in the pharmaceutical field in the U.S. for over a decade and is familiar with FDA standards, I would like to share some insights with readers.

In the U.S., pharmaceutical approval requires FDA-supervised clinical trials (phases 1, 2, and 3). This process takes a minimum of 5 to 15 years to complete and costs an average of $300 million to $700 million USD, with some cases exceeding $1 billion USD. Based on current exchange rates, this equates to approximately 400 billion to 1 trillion Korean won. Even with such immense investment, there is no guarantee of FDA approval. How many companies in the U.S. could afford such enormous investments? The situation becomes even more unlikely for companies overseas.

In Korea, there has been only one instance of FDA approval. This was for an orphan drug—a low-commercial-value antibiotic—obtained through a collaborative investment with a U.S. research institute. Other than this, none of the numerous pharmaceutical products sold and used in Korea have received FDA approval. (It’s worth noting that few people inquire, “Has this drug been FDA-approved?” before purchasing medication from a pharmacy.)

For prescription drugs to receive FDA approval in the U.S., the product must have a patent, consist of a single chemical structure, and undergo clinical trials specifically designed for physician-prescribed medications. Therefore, applying FDA standards to dietary supplements or alternative medicines is inherently nonsensical. Even if a company invests $3 million USD in FDA-supervised clinical trials for a non-patented dietary supplement or alternative medicine, the FDA will not allow it to make claims about the product’s effectiveness in treating or curing specific diseases. Without the ability to advertise its efficacy, the company would be wasting time and money.

Consider products sold in the U.S. market: how many dietary supplements or alternative medicines generate annual sales exceeding $100 million USD? Companies manufacturing products with sales below this threshold are unlikely to invest $300 million USD over 5 to 10 years to bring their products to market. Even prominent U.S.-based alternative medicine companies cannot undertake such efforts, let alone products from overseas markets such as Korea or China.

The FDA does not approve drugs imported from even advanced pharmaceutical nations like Japan unless they meet rigorous standards. Naturally, products from Korea or China face even greater challenges. Major U.S. pharmaceutical companies ensure that any unapproved drugs cannot be sold within the U.S., creating barriers for unauthorized imports. Therefore, products marketed in Korean communities as pharmaceuticals are often smuggled goods or illegal products lacking FDA approval. Legitimately imported products are classified as food and sometimes deceptively marketed as pharmaceuticals by unscrupulous sellers to lure consumers into paying higher prices.

When Koreans say, “This product has FDA approval,” what do they mean? This “FDA approval” refers to import permits, which guarantee that the food products are free of harmful substances like heavy metals, pollutants, bacteria, or pesticides. However, the safety inspection is not conducted directly by the FDA; rather, it is based on documentation submitted by importers. Incidents where products or foods are recalled due to contamination after approval are not uncommon. Thus, the term “FDA-approved product” does not equate to pharmaceutical approval.

In the U.S., dietary supplements and alternative medicines manufactured domestically do not require FDA approval, as there is no regulatory framework mandating such approval. Instead, the production company is responsible for ensuring that its products are free of harmful substances. However, the FDA strictly supervises the raw materials, manufacturing processes, and documentation involved in production. If these procedures fail to meet standards, the FDA immediately enforces production restrictions.

What about Korean or Chinese products sold in the U.S. through misleading advertisements claiming FDA approval? Such products generally evade FDA scrutiny because they target small ethnic markets, not the mainstream U.S. consumer base. If these products were boldly marketed to the general U.S. population with exaggerated claims, the FDA would take immediate legal action.

To receive FDA approval as a prescription drug in the United States, the product must first have a patent and consist of a single-component chemical structure. Additionally, only clinical trials conducted specifically for approval as a prescription drug will be recognized. Therefore, applying FDA approval standards or clinical trial requirements to dietary supplements or alternative medicines is inherently illogical.

Even if a dietary supplement or alternative medicine without a patent undergoes FDA-supervised clinical trials at a minimum cost of $3 million USD, it will not be allowed to make claims regarding its efficacy in treating or curing diseases, as pharmaceutical drugs do. Without the ability to claim what specific illnesses the product can effectively address, companies producing such products would essentially be wasting time and money.

How many dietary supplements or alternative medicines can generate annual sales of at least $100 million USD? For products unable to achieve this sales volume, investing $300 million USD or more over 5 to 10 years is impractical. Even the leading alternative medicine companies in the United States find this impossible, let alone overseas companies, particularly those from countries like Korea or China. It is simply unimaginable.

Even drugs produced by U.S. pharmaceutical companies that have received approval from the European FDA often fail to gain import approval as medicines in the United States. Products manufactured in Japan, a leading country in pharmaceutical production, face the same challenges, let alone products made in Korea or China. Furthermore, major U.S. pharmaceutical companies strictly prevent drugs that have not received FDA approval from being sold as medicines in the U.S.

As a result, all products marketed in Korean communities as if they were pharmaceuticals are either smuggled goods or illegal drugs that have not been approved by the U.S. FDA. Even products that are legitimately imported as food are often repackaged and marketed as pharmaceuticals by unethical sellers, deceiving consumers and distributing these products at high prices.

So, what does it mean when Koreans say, “This product has FDA approval”? This type of FDA approval refers to an import approval. Imported food products must undergo testing for heavy metals, contaminants, bacteria, pesticides, and other harmful substances to ensure their safety for consumers. Once these safety tests confirm there are no harmful materials present, the product is approved for import as a food item.

However, even this safety testing is not conducted directly by the FDA. Instead, the FDA approves imports based on documents submitted by importers. Post-approval, there have been frequent cases where products or foods are recalled and destroyed due to detected contamination by heavy metals or pesticides. Therefore, the term “FDA-approved product,” in this context, does not indicate pharmaceutical approval.

In the United States, dietary supplements or alternative medicines produced by domestic companies are not subject to legal requirements for FDA approval. In fact, there are no laws mandating product approval for these items. Naturally, products consumed by the public should not contain harmful substances, and the responsibility for ensuring this lies with the manufacturer’s ethical standards. However, the FDA strictly oversees the raw materials, ingredients, and manufacturing processes used. If the necessary documentation and testing for production quality are not adequately provided, the FDA can impose immediate production restrictions.

The FDA carefully monitors and manages all products manufactured in the U.S. If harmful substances are discovered in a product or if false advertising occurs—either accidentally or intentionally—the FDA promptly issues warnings and enforces measures such as banning the sale of the product (Off the Market).

What about products imported from Korea or China that are sold using exaggerated claims, such as “FDA-approved”? Such products often remain under the radar of the FDA because their market scale is too small or because they are not significant enough to target the mainstream U.S. market through exaggerated advertising. In essence, these products are ignored because they cater only to small ethnic communities. However, if these products were to boldly enter the mainstream U.S. market and operate as they do in Korean-American communities, the FDA would take immediate legal action.

What About Herbal Medicine? Most of the herbal medicine materials currently used in the market are said to be from China, according to a wholesale herbal material distributor. The reason is that even the majority of herbal materials produced in Korea are insufficient for domestic consumption and are mostly replaced by Chinese products disguised as Korean-made. So, is it likely that these materials would even make it to the United States?

Even if a product is labeled as Korean-made, there is no guarantee that it truly is. Herbal materials produced in Korea have faced challenges in production due to cost, supply shortages, and competition with cheaper Chinese products. As a result, production in Korea has become increasingly difficult.

Over a decade ago, there were efforts to obtain FDA approval for herbal medicines as alternative and complementary medicine. However, at present, the U.S. FDA considers herbal materials as foods with unproven efficacy and permits their import under this classification. The FDA also restricts exaggerated claims that these herbal materials can prevent or treat diseases.

The FDA’s stance is clear: if the specific active components or their mechanisms of action within the human body are unknown, they cannot be classified as drugs. For a particular herbal medicine to claim effectiveness against a specific disease, the chemical structure of its active components and how they work in the body must be scientifically proven.

In most cases, herbal medicine involves mixing and boiling various herbs, making it nearly impossible to isolate the active components. Furthermore, the chemical reactions that occur during the boiling process result in thousands or even tens of thousands of chemical compounds intermingling, further complicating the identification of specific active components and their mechanisms of action within the human body. This conclusion comes after over ten years of research in the field.

The U.S. FDA maintains that products lacking a solid scientific foundation cannot be considered as drugs.