Nutraceuticals promise a range of benefits. These natural supplements derived from food and herbs have been used for millennia. The growing popularity of natural and organic products has prompted lots of new players to offer nutraceutical products, sometimes at the cost of authenticity. 

Nutraceutical: New Name, Old Concept

A Nutraceutical is a fortified food or dietary supplement that provides health benefits in addition to its basic nutritional value. It’s a relatively new term, first documented in the 1990s.

While the name only came around in the ‘90s, the concept isn’t new. Herbal supplements are as old as human medicine. It’s how we package the concept that has changed.  

Modern day nutraceutical products present an opportunity for consumers to take their health into their own hands. These products play a significant role in daily routines, supporting well-being, and addressing specific dietary or wellness concerns. 

Nutraceuticals are a consumer favourite for their potential therapeutic properties and affordability. A range of products are widely available in stores and online. Products address a number of interests, from promoting general well-being to more specific concerns like inflammation. Add the relatively low price of nutraceuticals to the mix and it’s easy to understand why the market has grown so much in the past decade. 

Based on my quick survey of Google Shopping results, nutraceutical products range from Collagen Powder to Coconut Oil, Magnesium tablets to Zinc tinctures.

A Rapidly Expanding Market

Of course, my particular interest is in how functional mushrooms rank. They appear to be one of the fastest growing segments in the industry. Since September 2022, I’ve watched mushroom-based searches increase from 1,000 to 2,500 in monthly search rankings. Every week, more and more news stories featuring mushrooms appear.

The growth is largely attributable to expanding awareness of health and wellness, and interest in natural and organic products. As much as it pains me to say it, the pandemic really created a sense of urgency amongst consumers. Since 2020, the nutraceutical sector has experienced a 10% growth rate each year. 

The nutraceuticals sector was valued at $400 billion US in 2021, and is expected to grow to $800 billion US in 2030. 

Seems like a promising opportunity for aspiring entrepreneurs and for health enthusiasts alike. 

Challenging the Legitimacy of the Industry

The entrepreneurial spirit might just be what throws the legitimacy of the natural supplements sector into a state of disrepute. 

As the demand for products increases, so too does the availability of niche supplements and food products. Companies make a wide range of claims, some based on evidence and some based on anecdotal evidence. It’s very much a buyer beware type of market.

In some cases, the purported health benefits are exaggerated or even falsified. When randomly sampled products are tested, some have been found to contain active compounds in different chemical forms or different quantities than what is stated on the label. 

Nutraceutical Product Validity

Sometimes the issue of supplement validity is not a matter of deceit. It’s a matter of naming. 

Take, for instance, ginseng. 

Panax ginseng root with bunch of green leaves

Ginseng is one of the top selling nutraceutical products around the world. There are dozens of varieties of ginseng available on the market: Panax ginseng, wild ginseng, prickly ginseng, Pacific ginseng, Malaysian ginseng, Indian ginseng, Peruvian ginseng, Southern ginseng, Brazilian ginseng, wild-red ginseng. 

All of these herbal products are sold as ginseng.

Each of these products contain their own active ingredients. However, they may not deliver the expected benefits. Which in turn, creates buyer dissatisfaction and a sense that nutraceutical products just don’t work. 

What we face then is both a problem of perception and credibility.  

Are Nutraceuticals Bogus?

Does that mean nutraceuticals are bogus?

Not at all. It just means that health authorities have grown concerned about nutraceutical product claims and labelling. 

We know that traditional medicines have relied on herbs, plants and fungi for millennia. In these cases, experts knew what they were working with and prescribing.

When nutraceutical products hit the mainstream, the marketing machine took off. This is why labelling authorities – like the FDA – stepped in. 

As demand for nutraceutical products increases, natural product supply can quickly fatigue. Substitutions might be made. Standards of production may shift quickly to keep up with demand.

Wild harvested supplements may be subject to unintentional contamination including pathogens, pesticides, mycotoxin, heavy metals, or even lead. Some supplements may be ‘enhanced’ with prohibited drugs to improve efficacy.

That’s why, in many countries, nutraceutical products are starting to be regulated as drugs, food ingredients and dietary supplements. 

Nutraceuticals: Supplements or Drugs?

Regulations directing the labelling and claims made by natural products vary from country-to-country. 

According to Health Canada, a nutraceutical is a product isolated or purified from foods that is generally sold in medicinal forms not usually associated with food. A nutraceutical is demonstrated to have a physiological benefit or provide protection against chronic disease.

According to the FDA, most nutraceuticals would be categorized as “dietary supplements”. These are extracts, concentrates or combinations of vitamins, minerals, botanicals, herbs, or dietary substances  “for use by man to supplement the diet by increasing the total dietary intake.”

Nutraceuticals must maintain that they are not intended to treat, diagnose, prevent, or cure diseases. Labels may not make claims about treating pain, or preventing cancer.

Across North America, nutraceuticals are considered supplements – not drugs or pharmaceuticals. 

As a point of reference, the FDA defines a drug as “A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. A substance (other than food) intended to affect the structure or any function of the body.” 

Forthcoming changes in regulations may require nutraceutical labels to look a lot more like their pharmaceutical counterparts.

Nutraceutical Labelling

Pharmaceuticals, aka drugs, require a prescription and preparation by a trained pharmacist. An approved drug label in the United States is considered the official description of a drug product. The label will include what the drug is used for, who should take it, adverse events, instructions for use, and safety information. 

Nutraceuticals, on the other hand, are available as a consumer product, often sitting next to over-the-counter products at the drugstore. 

Nutraceutical labels will contain information about the contents of the package, instructions for use, and some safety information. 

In some cases, people might choose natural products over medical interventions for serious illnesses or take one that interacts with their current medications.

That’s why recent interest has the FDA reconsidering the availability of nutraceuticals: because they are thought to confuse consumers or cause unintentional harm.

The US introduced the Dietary Supplement Listing Act in 2022. This act would require supplement makers to register all products with the FDA. Each product world is required to list ingredients, and to explain health claims. 

What Actions Can a Company Take?

We know that the FDA, and other regulatory agencies, are worried about consumers. 

The key to avoiding complications with regulatory agencies – and to healthy supplement use – is consumer education.

Marketing nutraceutical products based on their potential benefits is still possible. The language about benefits must be clear, and offer insight into the ‘why’. If an academic paper was used to understand a benefit: state that. If the wisdom of traditional medicine was used to make a claim: state that. 

Absolute language can be misleading when taken out of context. Claiming something is a remedy for all difficulties or diseases requires data in modern commercial environments. 

To avoid regulatory hot water and to ensure the safety of consumers, nutraceutical producers can take a number of actions:

  • Label claims: Only present clinically proven claims on labels. Save the stories for marketing material where there is space for context.

  • Play it safe: Follow label guidance as required country-by-country

  • Test for authenticity: Rely on third party testing to ensure the contents of products are as stated on the label.

  • Test for safety: Rely on third party testing to ensure products are free of harmful substances.