FDA to Reform Regulations on Dietary Supplements: PMR

The US Food and Drug Administration announced that it would be revamping its regulations on the dietary supplements to strengthen its control on the sector. According to the press release by FDA, Scott Gottlieb stated that the new and improved regulations will be a significant modernization of the existing regulations on dietary supplements in over 25 years.

Additionally, the agency announced that is working towards creating a rapid response tool to caution the public and educate them against using products that may contain harmful and unlawful ingredients. The dietary supplement market in the USA is valued over $35 billion and the number of products available in the market has surged from 4000 to a staggering figure of 80,000 in the last 25 years. Gottlieb stated that multiple entities in the market are making misleading claims and selling potentially harmful medications to capitalize on the bolstering dietary supplements market in the country.

Under the reforms, the agency plans to tweak its compliance policies in relation to NDIs or dietary ingredients notifications according to which manufacturers involved in the production of dietary supplements will have to inform the FDA in case they are using any ingredients that were not sold in the country before 1994.  FDA believes the NDI notification will help the agency in testing the safety of any new ingredients before it could reach the consumers. The agency is also planning to create the Botanical Safety Consortium which will see private and public sectors collaborating for the research and evaluation of the safety of botanical ingredients which are to be used in supplements. As a part of its plan, the agency sent out a notification to 17 companies for marketing and selling products that claim to treat Alzheimer’s.

Weight loss supplements account for a significant portion of the dietary supplements market in America and the new announcement by the FDA is expected to positively influence the market in the region. A bulk of the leading players operating in the weight loss dietary supplements market are located in the North American region and the imposition of the regulations in the future is expected to bolster research and innovations in the market.

Weight loss dietary supplement manufacturers are increasingly incorporating the use of natural and organic products in production. With the “clean label” and “mindful choices” trend driving the pharmaceutical industry, the use of natural and organic ingredients is expected to fuel the weight loss dietary supplements market growth. Women are expected to continue to remain at the helm of consumption of the weight loss dietary supplements while the number of men using these supplements is estimated to grow substantially in the foreseeable future. These factors are expected to drive the weight loss dietary supplements market growth which is likely to be valued at over US$ 3.7 billion by the end of 2026.

However, growing incidences of side-effects due to consumption of the weight loss dietary supplements is expected to hinder market proliferation. Moreover, false claims and misleading marketing about the efficacy of the weight loss dietary supplement products is further expected to slow down the growth of the market.

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