Is your dietary supplement safe?

Like drugs, supplements are regulated, although the process is somewhat different. Drugs go through a rigorous approval process. A drug manufacturer must provide the Food and Drug Administration (FDA) with extensive data showing its product is safe and effective before it can be marketed and sold to the public.

Since dietary supplements aren't considered drugs, they can be marketed and sold without going through the same approval process. However, this doesn't mean supplements are not regulated. There are certain regulations that supplement manufacturers must follow. In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA). The act was an attempt to strike a balance between the manufacture and sale of dietary supplements — classified as a special type of food — and providing some oversight and regulation to a group of products that potentially could be hazardous to public health.

Essentially, the DSHEA:

  • Prohibits the use of supplements that are toxic or dangerous
  • Allows the secretary of the Department of Health and Human Services to ban supplement ingredients considered hazardous
  • Gives the FDA authority to implement a set of protocols, called Current Good Manufacturing Practices (CGMPs), that manufacturers must follow

To comply with the law, dietary supplement manufacturers must:

  • Register their facilities with the FDA and allow FDA inspectors access to their facilities for random inspections of the manufacturers' compliance with CGMPs
  • Make sure all claims and information on the product label and other labeling are truthful and not misleading
  • Follow CGMPs design to ensure supplement quality, including the identity, purity, strength and composition of the ingredients
  • Document and submit to the FDA all reports of serious adverse events associated with use of the supplement in the United States

Manufacturers don't have to:

  • Prove to the FDA that their products are safe and effective before producing or selling them — unless they contain an ingredient that's considered new, meaning it wasn't marketed before 1994. In this case, the FDA requires that the manufacturer provide specific safety information about the new ingredient.

It's important to note that according to Current Good Manufacturing Practices regulations, all supplements sold in the U.S. are mandated to have in the bottle exactly what is stated on the label. While the product offers no guarantees, you can feel more comfortable knowing that what you read on the outside is what you'll find on the inside. Granted, there are still some bad actors out there, but finding good-quality products is becoming easier.

July 02, 2019 See more In-depth

See also

  1. Add flax to your baking
  2. Calcium
  3. Calcium for better bones
  4. Calcium supplements for men
  5. Timing calcium supplements
  6. Calcium: Think outside the carton
  7. COVID-19 and vitamin D
  8. Can vitamins help prevent a heart attack?
  9. Can zinc supplements help treat hidradenitis suppurativa?
  10. Vitamin C and mood
  11. Eye vitamins: Can they prevent or treat glaucoma?
  12. Fiber supplements
  13. Flaxseed best when ground
  14. Flaxseed for breakfast?
  15. Ground flaxseed
  16. Heartburn medicines and B-12 deficiency
  17. Herbal supplements
  18. I have heavy periods. Should I take an iron pill?
  19. Integrative medicine: Different techniques, one goal
  20. Kratom and pregnancy: Not a safe mix
  21. Multivitamins for kids
  22. Nutrition: Does it come in a pill?
  23. Percent Daily Value
  24. Prebiotics, probiotics and your health
  25. Prenatal vitamins
  26. Magnesium supplements
  27. Nutritional supplements
  28. Are dietary supplements right for you?
  29. Bromelain
  30. Calories and nutrients to fuel sports performance
  31. Curcumin
  32. Dietary supplements: What to know before you buy
  33. Melatonin
  34. Smart practices for healthy living
  35. Tips for staying supplement savvy
  36. What are omega-3 fatty acids from fish oil?
  37. What are probiotics?
  38. What are multivitamin/mineral dietary supplements?
  39. What is Boswellia?
  40. What is ginger?
  41. What is whey protein?
  42. Vitamin C megadoses
  43. Vitamin C: An essential nutrient
  44. Vitamin D and MS: Any connection?
  45. Vitamin D: Can it prevent Alzheimer's & dementia?
  46. Vitamin D deficiency
  47. Can having vitamin D deficiency cause high blood pressure?
  48. Vitamin D: Essential with calcium
  49. Vitamin D for babies
  50. Vitamin D toxicity
  51. Vitamins for MS: Do supplements make a difference?
  52. What does a 'seal of approval' mean?
  53. Wheatgrass