May 22, 2015
Supplements are becoming part of people’s healthcare regimen, as consumers are increasingly using daily supplements to address a variety of age-related physical and mental conditions.
The vitamin and dietary supplements industry has grown tremendously in the past 15 years as its products have rapidly gained favor in the general public. Euromonitor International, a leading consumer markets researcher, estimated that 2014 vitamin and dietary supplement sales in the United States totaled more than $32 billion, representing a 6 percent annual sales growth. McKinsey & Company places the global value of the industry at $82 billion in U.S. dollars.
While supplements are commonly distributed in pill or tablet form, the Federal Drug Administration (FDA) nonetheless classifies them as a food rather than a drug. Their use is regulated primarily by the Dietary Supplement Health and Education Act of 1994.
Unlike with drugs, federal regulations do not require supplement manufacturers to get FDA approval before selling their products. FDA supplements regulations describing good manufacturing practices mandate that claims about the product on the label are “truthful and not misleading.” The FDA requires manufacturers to have written procedures for site sanitation, manufacturing operations, quality control functions and systems, testing, and handling product complaints. Regulations also require thorough production records, processing control specifications and testing of dietary ingredients and finished product samples for quality claims.
Any action the government takes to prohibit a supplement comes primarily after harmful effects are reported by the public. Natural Products Insider compiled yearly complaint data from the FDA and counted 10,585 complaints of adverse reactions to supplements between 2008 and 2013.
Besides these safety concerns, questions have been raised in independent tests and state investigations that supplements show little or no evidence of the substance listed on the label. Consumers have little ability to judge this for themselves, and this is a concern for many inside the industry as well.
Newsday quoted an unnamed FDA official stating that about 70 percent of nutritional supplements failed to follow good manufacturing practices during this time, including establishing effective quality controls during manufacturing, establishing proper production records and conducting independent testing to confirm product integrity.
As described in “Meeting the Demand for Quality Dietary Supplements,” UL suggests six ways dietary supplement manufacturers can create an effective compliance plan to advance trust in their company’s products.
- Sourcing of quality materials: Manufacturers must use factory audits, batch checks and periodic independent testing to check the quality and purity of their raw materials;
- Good manufacturing practices: These can help manufacturers achieve efficiencies that improve product quality and reduce costs;
- Product testing: Production processes should incorporate finished product testing to quickly identify potential challenges;
- Information management: Detailed, well-organized data provides evidence of FDA compliance and can address retailer requirements concerning quality;
- Independent validation testing: The best quality assurance programs use third-party testing to periodically confirm product content. A third-party validation mark can provide consumers added assurance about the supplement;
- Employee training: Proper training means employees are more likely to understand why policies are in place and a better appreciation of their importance in the manufacturing process.
By adopting these steps, dietary supplements manufacturers can make what they do more transparent, building the trust of their customers and helping ensure the continued success of the industry.