The New Dietary Ingredients (NDI) draft guidance will over-regulate and weaken the supplements industry, according to prominent dietary supplements manufacturer, Jarrow Formulas.
The Food and Drug Administration (FDA) first issued the NDI guidance in 2011 in an effort to further define the regulations set in the Dietary Supplement Health and Education Act of 1994 (DSHEA) and makes products safer for consumers. The 2011 guidance was met with resistance from politicians and industry experts due to the definition of chemical alteration and intensive submission process. A newer draft guidance was released in July of 2016 with clarification about the designation “chemical alteration” and more reasonable submission requirements.
Jarrow accuses the guidance of creating inappropriate food additive guidelines. The contract manufacturer argues that many ingredients already used in supplements that have demonstrated safety through little to no adverse events, are now considered adulterated based on the language used in the draft guidance. Jarrow cites the use of solvents other than water or ethanol during the extraction process would be considered adulterated under the new law; solvents such as hexane and acetone have been used for many years following the passage of DSHEA without incident.
Next, Jarrow takes issue with the FDA’s view on synthetic botanical constituents. They argue that because Good Manufacturing Practices require consistency, reliability, and predictability, synthetic botanicals are necessary to combat seasonal availability issues, heavy metal and pesticide contamination, and to protect threatened species of botanicals. They claim that synthetics should fall under the definition of “dietary substance for use by man to supplement the diet by increasing the total daily intake” per DSHEA.
The FDA’s counterargument is that synthetic botanicals are copies and were not derived from the natural plant. Thus, they are not dietary ingredients. Jarrow goes on to mention CoQ10, which is a well-known synthetic, accepted as a dietary supplement, available to consumers. To Jarrow, it does not make sense that the FDA has singled out synthetics as CoQ10, which has been a prominent fixture in the industry. Ingredients are not always readily available. One growth season could be inconsistent with another and could create a shortage. It is only one of the many possibilities manufacturers face when relying on natural ingredients. Synthetics are necessary to produce consistent products to bypass shortages or unusable ingredients.
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