Dietary supplements and natural substances IP and regulation

Dietary supplements

Dietary supplements have seen an increase in popularity over the past few years as the dietary supplements-based medicine field has gained interest.

According to Fortune, “The global dietary supplements market size was USD 61.20 billion in 2020. The market is projected to grow from USD 71.81 billion in 2021 to USD 128.64 billion in 2028 at a CAGR of 8.68% during the 2021-2028 period.”

Dietary supplements can be used simply to fill gaps in one’s diet, but many claims to work miracles for weight loss, curing disease symptoms, and more.

 Dietary supplements regulation

While many people claim dietary supplements have changed their life, it is a challenging field to regulate. While the FDA has regulations for dietary supplements, the Dietary Supplement Health and Education Act (DSHEA) of 1994 has dramatically decreased the involvement of the FDA in the dietary supplement market.

According to the FDA, “under DSHEA, FDA is not authorized to approve dietary supplements for safety and effectiveness before they are marketed.” This means that dietary supplements can be marketed to individuals, put on shelves, or sold online without being regulated by the FDA.

 Dietary supplements clinical evidence

This restriction of the FDA causes a lot of misinformation about dietary supplements to be spread, diluting the real value of these compounds, dealing with safety and quality issues, and the lack of efficacy indication of these products. Many predatory brands state false claims about curing illnesses and prey on vulnerable individuals looking for alternatives to Western medicine.

Many times when people look towards dietary supplements-based medicine, it is because they have been failed by many allopathic treatments and are using it as a last resort. These people can be very vulnerable, and with false claims of curing diseases like cancer or diabetes together with no clinical evidence of these products, they can waste their time and money as they race to find a treatment that will help. With so much incorrect information in the industry, it is easy to forget that many of these supplements can help if taken correctly.

Due to the lack of regulation by the FDA, there is not much clinical proof in the field of dietary substances. Only a few companies worldwide have clinically tested their dietary supplement formulas for efficacy. Because it is not required, many companies will not spend time and money on clinical studies, which leaves it to research institutions to test the efficacy of supplements.

Additionally, since these substances occur naturally, it is difficult to have intellectual property over the supplements, which creates issues when trying to perform clinical trials. Some pharmaceutical companies have combatted this by manipulating the substances in the lab to a chemically similar compound which they can then patent. This allows companies to have clinical trials on these natural supplements.

Per FDA guidelines,  Even if the study product is already available on the market as a dietary supplement, an IND (Investigational New Drug) file will be required for products that will be used as a drug to treat, mitigate or prevent a disease or its related conditions in the proposed clinical study. On the other hand, no IND will be required for studies on structure and function endpoints, and not on drug use.

 Quality and GMP in the Dietary supplements industry

In addition to regulation, natural substances, such as botanical extracts and nutrition supplements, must follow strict quality control guidelines and GMP. These products can yield different results from the slightest variation to quality issues during the growing and extraction processes through the compounding, tableting/capsulation, filling, and packaging stages.

This adds a level of complexity when working with natural substances when compared to typical drugs.

Due to the DSHEA, dietary supplements are not closely monitored until something is reported as wrong. This allows companies to disregard control guidelines and GMP set by the FDA, resulting in poor-quality substances. This can be unsafe for patients taking the supplements, as the FDA may never even investigate some supplements due to the overwhelming amount of available products.

The FDA must become more involved with the regulatory process for dietary supplements and natural substances to be used in medicine. While dietary substances may not completely replace pharmaceutical drug products, they can be used in tandem with Western medicine to benefit patients.

The FDA must switch the classification of dietary supplements to drugs as opposed to food for there to be verified information about what the supplements can be used for. This reform is a big task, as there are currently thousands of dietary supplements being sold to the public without proper clinical research to back up their claims. Another way to improve the efficacy of the industry is to ensure doctors ask if patients are taking any supplements and report any adverse effects to the FDA.

 Dietary Supplements Market Dynamics

The dietary supplements market is divided into the segments based on supplement type, such as:

  • Vitamins
  • Minerals
  • Probiotics
  • Botanicals
  • Amino acids

 Of these segments, botanicals are projected to account for the highest CAGR, while vitamins hold the largest market share.

Many key market players, especially in the North American sector, account for fierce competition when entering the market. These players have been focusing on strengthening their reach through collaborations and strong distribution networks.

An essential market driver is the self-care movement which increased in popularity during the COVID-19 pandemic. People are turning towards dietary supplements products and natural treatment methods to supplement their diets to achieve their health goals.

Companies have capitalized on personalization and convenience of delivery to draw in customers and help them with their self-care needs. Care/of curates a personalized mix of supplements based on a customer’s wants and needs packs them in daily packages and delivers them to the customer each month. This method has brought an innovative way for companies to reach their target market.

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