BDO recently had the opportunity to sit down with Dr. Sreek Cherukuri, a consumer advocate in the dietary supplement space to get a better understanding of the history of FDA regulations on the supplement industry, what the FDA hopes to achieve with recent changes and how consumers can protect themselves when in the market for dietary supplements to include in their daily lives. Since 1994 the dietary supplement market has boomed, growing from a $4 billion industry to one today worth over $40 billion.
The FDA estimates that 3 out of 4 American adult consumers take a dietary supplement daily. It was 25 years ago that Congress passed the Dietary Supplement Health and Education Act (DSHEA) the first major piece of legislation establishing requirements for the manufacture and labeling of dietary supplements.
At the time DSHEA was passed there were an estimated 4,000 unique dietary supplement products available, today the FDA states that there are anywhere from 50,000-80,000+ products. However, there is no way to accurately know the number because entities are not required by law to register with the government. With such growth and lax regulations in the sector, there have been companies that have come to market with products that are not what they claim to be and even put consumers at risk.
“In America, one of the only products that you can purchase to put into your body that is not regulated are dietary supplements and vitamins. Contrary to popular belief, the FDA does not require supplement manufacturers to register with the government. In fact, products are assumed and presumed safe until it causes harm” says Dr. Cherukuri, adding “there is no FDA review before they come to market.”
Additionally, the FDA does not require oversight or registration of the ingredients used in products. The FDA only reviews a product after it has been on the market, been sold, caused harm to someone and has been reported.
In the new changes proposed by the FDA, they seek common sense regulation to better keep tabs on the growing industry. Regulations such as requiring the registration of companies with the FDA, which will allow for better accounting of all of the products and entities on the market. Also requiring that companies register their ingredients with the FDA, allowing for the creation of a database that can be used to compile drug interactions and other key pharmaceutical information.
Today the FDA has a list of over 800 banned products and substances that have been proven to cause harm to consumers, the vast majority coming from three major categories: weight loss, weight gain, and sexual performance.
Dr. Cherukuri encourages all consumers to be aware of products advertising these benefits, as there have been no clinical studies proving the efficacy of any non-prescription products in achieving these results. Dr. Cherukuri also encourages consumers to do their own research when choosing products and ingredients to supplement their diets.
Studies have shown that as many as 40% of the reviews found online on sites like Amazon.com are fake or paid for, so digging deeper and looking for clinical studies on
ingredients are vital.
Additionally, Dr. Cherukuri recommends that consumers look for products that have third-party testing to verify that their contents, in fact, include what they claim. https://www.smartceuticals.org/ is one resource that Dr. Cherukuri suggests consumers use to research information on dietary supplements.
Dr. Kevin Kinney, board certified and licensed Chiropractic Physician featured on INSIDER.com, TheTodayShow.com & BlackDoctorsMatter.org. Connect with Dr. Kev at drkevinkinney.com or @DrDuval904
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