Regulatory Landscape for Nutraceuticals

The nutraceuticals industry in the U.S. operates within a complex regulatory framework as products are overseen by both the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). The FDA regulates nutraceuticals as food rather than as drugs since these products are consumed orally and labeled for use as supplements to the diet. Under the Dietary Supplement Health and Education Act (DSHEA) passed in 1994, dietary supplements are defined as vitamins, minerals, herbs, amino acids and other botanicals that are intended to supplement the diet. DSHEA places responsibility on producers to ensure product safety and provide evidence of safety if health claims are made on labels U.S. Nutraceuticals Market Trends

. However, the standard for approval is lower than for pharmaceutical drugs.

U.S. nutraceuticals market was valued at US$ 86.78 Million in 2021 in terms of revenue, exhibiting a CAGR of 5.52% during the forecast period (2022 to 2030).

The FTC oversees advertising and labeling claims to ensure product marketing is truthful and not misleading. All claims must have scientific evidence backing them up or risk being classified as deceptive. In conjunction, the two agencies aim to balance ensuring public access to safe nutraceutical products while limiting health claims to those sufficiently proven. The stricter new drug approval pathway would stifle innovation in the sector, while looser oversight could potentially endanger consumers. The current system seeks a middle ground approach.

Popular Categories and Top-Selling Products

Several main categories exist within the large and varied nutraceuticals industry. Dietary supplements containing herbs, vitamins, minerals, and other botanicals represent the largest portion by revenue. Probiotics, which support digestive and immune health, have grown rapidly in popularity. Protein supplements used for bodybuilding and fitness purposes generate strong sales. Omega-3 fatty acids and other fatty acids used to promote heart and brain health are another big segment.

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