In the early 1990s, a contaminated batch of L-tryptophan resulted in the deaths of 38 people and left 1500 others with devastating neurological conditions (some were paralyzed for life). In 2004, Ma Huang (Ephedra) was banned after it was linked to organ damage and death. It is found in diet supplements to this day, although it is obviously not listed on the label. In 2013, OxyElite Pro, a popular dietary supplement with “a blend of exotic botanical extracts” said to burn fat, sharpen mental focus, suppress appetite, and boost energy caused liver damage in dozens of people, including three who required a liver transplant and a mother of seven who died as a result. At fault was a synthetic version of aegeline, which is used in Ayurvedic medicine.
Other ingredients found in “natural” supplements in recent years include:
- Sibutamine – the active ingredient in Meridia, which was banned in 2010 because it caused heart attacks and strokes
- Lorcaserin – causes life-threatening serotonin syndrome when combined with common antidepressants
- Sildenafil – Viagra
- N,α-dimethylbenzeneethanamine (N, αDEPA)– chemical cousin of methamphetamine
- Environmental toxins including mercury and lead
- DMAA (“geranium extract”) – causes heart attack, psych disorders, and death
- Fluoxetine – active ingredient in Prozac
- Methylsynephrine – a stimulant that increases blood pressure and stimulates the heart, not approved in the U.S. and can cause vomiting, agitation, and cardiac arrest
The Dietary Supplement Health and Education Act of 1994 (DSHEA) defined supplements as a distinct regulatory category, subject to far fewer regulations than drugs.
Since 2007, per the DSHEA, manufacturers are required to report serious (life-threatening) adverse effects. Notifying the FDA of an adverse event is not an admission that the product caused the adverse event. The FDA gets about 1,700 incidents a year, although the true amount of reportable incidents is probably around 50,000.
Supplement manufacturers do not have to get FDA approval before producing or selling supplements. They also don’t have to prove that the supplement does anything to benefit health. However, manufacturers and distributors are supposed to notify the FDA of their intention to market a new product and supply them with the information used to conclude that the main ingredient is generally safe to consume. Companies can make claims about benefits of supplements with minimal evidence, as long as they don’t say that the supplement will prevent or cure a specific disease.
DSHEA puts the responsibility to prove that supplement are adulterated, or misbranded, or present significant or unreasonable risk of injury or illness squarely on the FDA’s shoulders. There are roughly 75,000 supplements on the market with sales of $40 billion annually. The FDA’s Office of Dietary Supplements has two dozen employees.
In a 2013 analysis of 44 herbal supplements made by 12 different companies, 1/3 contained no trace of the “main ingredient” and half contained contaminants or unlisted fillers like rice and grasses.
In 2015, the NY State Attorney General Eric Schneiderman commissioned DNA barcoding of 78 supplements bought at four major retailers. Only 21% of the supplements showed evidence of the herbs that they supposedly contained. Many contained potential allergens not disclosed on the label, including wheat, walnut, and houseplants.
What You Can Do:
- Consult your doctor before starting any supplement.
- Avoid products that make exaggerated claims.
- Some experts recommend choosing supplements that contain no more than six ingredients; others recommend only one ingredient.
- Look for Quality Seals – NSF International, USP, or UL.
- Research ingredients and manufacturer online from reputable sources:
http://www.consumerlab.com/ (paid membership)