Regulations Related to Dietary Supplements
Since Passage of DSHEA
| April 1995 | Pursuant to DSHEA's exclusion of dietary ingredients of dietary supplements from food additive regulation, FDA withdrew its relevant "regulatory guidance." | Federal Register, Vol. 60, April 19, 1995, p. 19597 |
| December 1995 | FDA issued a proposed rule to increase flexibility of label claim language and refine other NLEA provisions in response to citizen petitions. | Federal Register, Vol. 60, December 21, 1995, pp. 66206-66227. |
| December 1995 | FDA issued a proposed rule concerning food label requirements for nutrient content claims, health claims and statements of nutritional support for dietary supplements. | Federal Register, Vol. 60, December 28, 1995, pp. 67176-67184 |
| December 1995 | FDA issued a proposed rule concerning the definition for "high potency" claims for dietary supplements and the definition of "antioxidant" when used in nutrient content claims of dietary supplements. | Federal Register, Vol. 60, December 28, 1995, pp. 67184-67194 |
| December 1995 | FDA issued proposed rules governing the labeling of dietary supplements with respect to the statement of identity, nutrition labeling and ingredient labeling. | Federal Register, Vol. 60, December 28, 1995, pp. 67194-67224 |
| March 1996 | FDA issued a final rule on health claims and label statements concerning folate and neural tube defects. | Federal Register, Vol. 61, March 5, 1996, pp. 8752-8781 |
| April 1996 | FDA declared that DSHEA does not apply to dietary supplements intended for use in animals other than humans. | Federal Register, Vol. 61, April 22, 1996, pp. 17706-17708 |
| August 1996 | FDA issued a final rule providing for a health claim for sugar alcohols and nonpromotion of dental caries. The health claim may be used with eligible foods and dietary supplements. | Federal Register, Vol. 61, August 23, 1996, pp. 43433-43447 |
| September 1996 | FDA issued a proposed rule spelling out the procedure by which companies would notify FDA of dietary supplement products bearing statements of nutritional support. | Federal Register, Vol. 61, September 27, 1996, pp. 50771-50774 |
| September 1996 | In response to DSHEA's new dietary ingredient provisions, FDA published a proposed rule that would establish the procedure for premarket notification of a new dietary ingredient. | Federal Register, Vol. 61, September 27, 1996, pp. 50774-50778 |
| January 1997 | FDA issued a final rule on required warning statements and packaging requirements for iron-containing dietary supplements and drugs. | Federal Register, Vol. 62, January 15, 1997, pp. 2218-2250 |
| January 1997 March 1997 |
FDA issued a final rule providing for a health claim for soluble fiber from whole oats and reduced risk of coronary heart disease. The health claim may be used with eligible foods and dietary supplements. FDA amended the final rule in March 1997 to clarify the regulation. | Federal Register, Vol. 62, January 23, 1997, pp. 3584-3601
Federal Register, Vol. 62, March 31, 1997, pp. 15343-15344 |
| February 1997 | Acting on DSHEA's provision that HHS may prescribe good manufacturing practices for dietary supplements, FDA issued an advance notice of proposed rulemaking in February 1997 announcing that it was considering whether to institute rulemaking to develop current good manufacturing practice regulations for dietary supplements and dietary supplement ingredients. | Federal Register, Vol. 62, February 6, 1997, pp. 5700-5709 |
| May 1997 | FDA proposed to extend the health claim on the association of soluble fiber and reduced risk of coronary heart disease to include soluble fiber from psyllium husks. | Federal Register, Vol. 62, May 22, 1997, pp. 28234-28245 |
| June 1997 | FDA proposed rules on dietary supplements containing ephedrine alkaloids. | Federal Register, Vol. 62, June 4, 1997, pp. 30678-30724 |
| July 1997 | FDA published a final rule in which the agency did not modify the definition of "imminent hazard to the public health" in 21 CFR 2.5. | Federal Register, Vol. 62, July 23, 1997, pp. 39439-39440 |
| September 1997 | FDA issued a final rule amending food labeling regulations concerning statements of identity and nutrition labeling of dietary supplements. The rule also revokes Compliance Policy Guide 530.400 (CPG 7121.02). Effective date: March 23,1999. | Federal Register, Vol. 62, September 23, 1997, pp. 49826-49858 |
| September 1997 | FDA published a final rule amending food labeling requirements for nutrient content claims, health claims, and statements of nutritional support for dietary supplements. Effective date: March 23, 1999. | Federal Register, Vol. 62, September 23, 1997, pp. 49859-49868 |
| September 1997 | FDA published a final rule amending the definition of "high potency" claims for dietary supplements and amending the definition of "antioxidant" for use in nutrient content claims for dietary supplements. Effective date: March 23, 1999. | Federal Register, Vol. 62, September 23, 1997, pp.49868-49881 |
| September 1997 | FDA responded to comments on a final rule establishing a uniform date of January 1, 2000, for compliance with food regulations issued between January 1, 1997, and December 31, 1998. Effective date: December 27, 1996. | Federal Register, Vol. 62, September 23, 1997, pp. 49881-49883 |
| September 1997 | FDA issued a final rule on notification procedures for statements on dietary supplements. Effective date: October 23, 1997. | Federal Register, Vol. 62, September 23, 1997, pp. 49883-49886. |
| September 1997 | FDA issued a final rule on premarket notification for new dietary ingredients. Effective date: October 23, 1997. | Federal Register, Vol. 62, September 23, 1997, pp. 49886-49892. |
Commission on Dietary Supplement Labels