Please Note: This post is intended as a Part 2 follow-up to: “Taking Supplements in the New Year? Beware of Economic Adulteration.”
“Dietary supplements are unregulated.”
I’m sure you’ve heard this statement in the press or on the news. But on the contrary, dietary supplements are highly regulated and have been since the passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994.
One of the most important parts of this Act is a provision called the Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding Operations for Dietary Supplements (cGMP). It’s found in 21 code of Federal Regulations (CFR) Part III. This regulation lays out the responsibilities our industry has for ensuring the quality of dietary supplements — including vitamins, minerals, probiotics, amino acids, botanicals and other compounds meant to supplement our diets.
Testing for Quality and Safety
Under this provision, FDA requires companies to measure and monitor any raw materials used, as well as the purity, strength and composition of the finished product. This process ensures that the product in the bottle matches the amounts shown on the Supplement Facts panel.
The provision also requires the manufacturer and brand owner to provide a finished product free of all potential contaminants. Along with product monitoring, cGMPs define the minimum expectations of the facility manufacturing the product — including:
- Cleaning and sanitation practices
- Employee hygiene practices
- Manufacturing processes
- Quality control procedures
Under FDA regulations called the Food Safety Modernization Act (FSMA), designed to shift the focus from responding to food-borne illness to preventing it and signed into law in January 2011, ingredient suppliers are required to evaluate the entire manufacturing and processing of dietary supplements and food ingredients. This may include documentation going all the way back to the farm where it was grown. During this evaluation, raw materials are considered for all potential hazards — including intentional contamination.
The Downside to Some Supplements: What You Should Know
Sadly, as with any industry, some dishonest companies sell low-quality and illegal products — many of which are falsely labeled as dietary supplements. Some of these products are intentionally contaminated with pharmaceutical adulterants.
For example, the FDA has previously found contamination of weight-loss products, including those with sibutramine and other pharmaceutical compounds. In 2010, the FDA asked the maker of sibutramine to pull the drug from the market and advised physicians to stop prescribing it for patients due to potential health problems.
Here’s the “rule of thumb” for savvy consumers: If the claims on a label or advertisement sound too good to be true, they probably are. Before ordering a questionable weight-loss product, check available resources — include the FDA web page: Tainted Weight Loss Products.
The Bottom Line
Dietary supplements can provide amazing benefits. Many are created to address nutrient deficiencies or are based on the historical use of high-quality botanicals. The use and effect of some traditional remedies can be documented going back thousands of years!
So, look for responsible, ethical companies to provide you with high-quality products which meet or exceed FDA cGMPs. Don’t be fooled by dishonest ads from irresponsible companies that may be making false claims! These illegal products are likely masquerading as dietary supplements, and they may be contaminated. Use a brand you can trust.
About the Author:
Larisa Pavlick has more than 22 years of experience working in the dietary supplement industry — including nearly eight years as an investigator for the U.S. Food and Drug Administration. She has a passion for the dietary supplement and natural products industry and for helping others.
Ms. Pavlick is the V.P. of Global Regulatory and Compliance at United Natural Products Alliance (UNPA) — an international association representing more than 100 leading natural products, dietary supplements, functional foods, and scientific, technology and related service companies that share a commitment to providing consumers with natural health products of superior quality, benefit and reliability.