The U.S. Food and Drug Administration issued a revised draft guidance to improve dietary supplement companies’ new dietary ingredient premarket safety notifications to the agency. These notifications help the agency identify safety concerns before products reach consumers.
Under the Dietary Supplement Health and Education Act (DSHEA), the manufacturer or distributor must notify the FDA at least 75 days before beginning to market a dietary supplement that contains a new dietary ingredient, unless the new ingredient is used in the food supply without chemical alteration.
Dietary supplements are considered adulterated if they contain a new ingredient not used in the food supply and the required notification has not been submitted to the FDA 75 days before marketing.
The FDA encourages public comments on the revised draft guidance during the 60-day comment period.
55,000+ dietary supplements
The FDA estimates that:
- There are more than 55,600 dietary supplements on the market.
- 5,560 new dietary supplement products come on the market each year.
- Fewer than 1,000 NDI notifications have been sent to the FDA since DSHEA was passed in 1994.
“This revised draft guidance is an important step forward in the agency’s work to protect public health from potentially dangerous new dietary ingredients,” said Steven Tave, acting director of the FDA’s Office of Dietary Supplement Programs. “Notification of new dietary ingredients is the only pre-market opportunity the agency has to identify unsafe supplements before they are available to consumers. The revised draft guidance is intended to improve the quality of industry’s new dietary ingredient reporting so the FDA can more effectively monitor the safety of dietary supplements.”
Over the past three years, the FDA has taken numerous actions on dietary supplements, including action on several products containing new dietary ingredients that pose safety concerns and should have been the subject of an NDI notification but were not, such as Acacia rigidula.
The agency reaffirmed its commitment to remove from the market products that contain potentially harmful pharmaceutical agents, are otherwise dangerous to consumers, or are falsely labeled as dietary supplements; enforce the dietary supplement good manufacturing practices regulation; and take action against claims that present a risk of harm to consumers (such as egregious claims of benefit in treating serious diseases) or economic fraud.
Avoid 15 Dangerous Supplements
Consumer Reports identified 15 supplements that cause death or damage to the kidneys, liver and heart.
Also called: Aconiti tuber, aconitum, angustifolium, monkshood, radix aconti, wolfsbane
|Reduces inflammation, joint pain, gout||Nausea, vomiting, weakness, paralysis, breathing and heart problems, possibly death|
Also called: 1,3,7-trimethylxanthine
|Improves attention, enhances athletic performance, weight loss||Seizures, heart arrhythmia, cardiac arrest, possibly death; particularly dangerous when combined with other stimulants|
Also called: Creosote bush, greasewood, larrea divaricata, larrea tridentata, larreastat
|Weight loss; improves inflammation; treats colds, infections, skin rashes, cancer||Kidney problems, liver damage, possibly death|
Also called: Coughwort, farfarae folium leaf, foalswort, tussilago farfara
|Relieves cough, sore throat, laryngitis, bronchitis, asthma||Liver damage, possible carcinogen|
Also called: Blackwort, bruisewort, slippery root, symphytum officinale
|Relieves cough, heavy menstrual periods, stomach problems, chest pain; treats cancer||Liver damage, cancer, possibly death|
Also called: Teucrium chamaedrys, viscidum
|Weight loss; alleviates fever, arthritis, gout, stomach problems||Liver damage, hepatitis, possibly death|
Also called: Celandine, chelidonium majus, chelidonii herba
|Alleviates stomachache||Liver damage|
|Green Tea Extract Powder
Also called: Camellia sinensis
|Weight loss||Dizziness, ringing in the ears, reduced absorption of iron; exacerbates anemia and glaucoma; elevates blood pressure and heart rate; liver damage; possibly death|
Also called: Ava pepper, kava kava, piper methysticum
|Reduces anxiety, improves insomnia||Liver damage,exacerbates Parkinson’s and depression, impairs driving, possibly death|
Also called: Asthma weed, lobelia inflata, vomit wort, wild tobacco
|Improves respiratory problems, aids smoking cessation||Nausea, vomiting, diarrhea, tremors, rapid heartbeat, confusion, seizures, hypothermia, coma, possibly death|
Also called: Oxilofrine, p-hydroxyephedrine, oxyephedrine, 4-HMP
|Weight loss, increases energy, improves athletic performance||Causes heart rate and rhythm abnormalities, cardiac arrest; particularly risky when taken with other stimulants|
Also called: Hedeoma pulegioides, mentha pulegium
|Improves breathing problems, digestive disorders||Liver and kidney failure, nerve damage, convulsions, possibly death|
|Red Yeast Rice
Also called: Monascus purpureus
|Lowers LDL (“bad”) cholesterol, prevents heart disease||Kidney and muscle problems, liver problems, hair loss; can magnify effect of cholesterol-lowering statin drugs, increasing the risk of side effects|
Also called: Beard moss, tree moss, usnea
|Weight loss, pain relief||Liver injury|
Also called: Johimbi, pausinystalia yohimbe, yohimbine, corynanthe johimbi
|Treats low libido and erectile dysfunction, depression, obesity||Raises blood pressure; causes rapid heart rate, headaches, seizures, liver and kidney problems, heart problems, panic attacks, possibly death|