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How Are Nutraceutical Products Regulated?

Science contains a lot of complicated, near brain breaking terms. Physicists discussing the properties of light go into territory that makes you feel like you’re unlearning language as it progresses. If it’s difficult to describe what something is, it’s difficult to describe how it works and where it belongs.

Hence the problem with regulations concerning nutraceutical products. Do they count as supplements? Do they count as food?

Each of these categories has different standards and falls under the purview of completely different agencies from one country to the next. It’s simply difficult to regulate something that is difficult to define. The more variable the language used to describe a thing, the more difficult it is to regiment.

Much like the film and video game industries, the nutraceuticals industry has found itself needing to create its own internal regulations. 

Defining Nutraceutical Products

Everyone wants products to be safe, effective, and affordable. Reaching these goals requires a careful consideration and implementation of best practices. Too much of any of the three creates problems in the others.

For example, water is a safe product. So safe that outside the vital effect of hydration it isn’t shown to be effective at anything else. Potent, and therefore effective, substances are often expensive because they contain so much concentrated material. 

Further complicating this formulation is what is and what is not allowed to be defined as a nutraceutical. In the US the FDA pushed them into the dietary supplement category. Other countries such as the UK and Canada employ broader definitions.

When a nutraceutical shows promising results in treating a disease or condition, it can be moved and reclassified. This is done on an individual basis without changing the definition of the group as a whole. 

Whether a nutraceutical gets defined as dietary supplements, natural health products, or special health foods is unimportant to the consumer. These definitions matter to governing bodies in an attempt to streamline nuanced processes. Regardless of category, a nutraceutical is a specific grade of vitamins, extracts, minerals, and herbs.

The grade is important because it differentiates between other substances in the food and supplements categories. 

Regulation Overview

Regulation covers more than simply what is and isn’t legal. It also covers how a product is to be produced, shipped, and marketed.

On top of that, regulations determine what market barriers need crossing and what burdens of quality and evidence need applying. 

Under the 1994 Dietary Supplement Health and Education Act (DHEA), the FDA considers pharmaceuticals unsafe until proven safe. Supplements, on the other hand, are considered safe until proven otherwise. Recommendations on usage and dosage also need verification for safety. 

Efficacy further widens the divide between the FDA’s distinctions on these two outdated groupings. 

Manufacturing Standards

Standards in manufacturing effect the regulation of most products. No matter how safe and effective a product may be, if it can’t be manufactured consistently, in large volumes, and transported, it’s useless. 

The standards for nutraceuticals need to keep the end product fresh and viable for a known length of time. It needs to be delivered in a way that ensures the product isn’t broken or lost in transport.

The regulations for these standards are industry-produced and generally follow those of pharmaceuticals. After all, both deal with bioactive substances derived from herbal and botanical origins that must maintain a consistent purity and safety per unit.

Industry Regulations

Also like the pharmaceutical industry, nutraceuticals create pricing concerns. In both industries, the cost to produce the product is a tiny fraction of the cost to develop. 

In the case of nutraceuticals, the research and development may be less than pharmaceuticals but the cost of the base ingredients is higher. 

When a product is created from only all-natural substances or organic ingredients, these increase the cost while also lowering the supply. Products that allow for bioengineered substances are obviously in their own category.

Research costs also differ when it comes to testing. A product that boosts is easier to test than a product that eliminates. It’s easier to show the benefit of a vitamin at a concentration than it is to show the elimination of bacteria. 

Medical Claims

Nutraceutical products have to be careful about the claims that they make. Under FDA guidelines the reversal of safety requirements comes in part from the claims made of the product.

It’s far more difficult to prove that a product is safe, if for no other reason than the long-term studies required to show ongoing use effects. Cataloging and accounting for side effects is also far more difficult. 

The regulations that exist make researching effects difficult. Industry producers are careful to temper expectations.

Quality Control

Even when no specific claim is being made, a nutraceutical is developed to produce an effect. To create the same effect a product needs to be of a certain quality. This requires testing and equipment designed to look for, and weed out, impurities and contaminants.

Testing for the presence and concentrations of active ingredients is necessary but becomes an issue with classification. Testing standards of a supplement are different than testing standards of foods. It’s possible to clear one definition but not the other, which puts nutraceutical producers in a bind without clearer information.

Advertising Standards

To put a product on the market, a company needs to provide labeling information. This information is a product of the claims and the quality control.

Internal regulatory boards such as the National Organic Program and the Online Wellness Library help to package this labeling information into a standard that communicates clearly with the consumer.

It’s also important for the industry to have a standard to abide by for purposes of competition. A healthy marketplace needs competition but also a fair field. The industry suffers without regulations on how to word claims, how to report and measure ingredients, and what manufacturing standards to use to keep production costs stable.

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