EMORD & ASSOCIATES P.C.

Senate Bill 722 ("SB 722") was introduced on March 26, 2003 by Senator Richard Durbin (D-IL). SB 722, if passed, will amend the Federal Food, Drug and Cosmetic Act to require manufacturers of dietary supplements and packers and/or distributors whose names appear on the label of a dietary supplement to report to FDA serious adverse experiences associated with the consumption of the supplement. If passed, SB 722 would require supplement manufacturers and/or packers or distributors whose names appear on the label of the supplement to develop written procedures for surveillance, receipt and evaluation of the information concerning adverse dietary supplement experiences. Upon receipt of a report of a serious adverse dietary supplement experience manufacturers would be required to investigate the incident and report it to FDA as soon as possible, but in no event later than 15 days after obtaining the information.

Under SB 722 FDA is responsible for conducting a clinical evaluation of each reported serious adverse experience. If FDA’s clinical evaluation indicates that the dietary supplement presents a significant or unreasonable risk of illness, FDA can require that the manufacturer of the supplement submit to FDA data demonstrating the supplement is safe. FDA is then required to review the data and issue a determination as to whether the dietary supplement is safe and can continue to be marketed or that the supplement is unsafe and cannot continue to be marketed.

SB 722, if passed would require periodic adverse dietary supplement experience reporting. The Bill would require supplement manufacturers to submit annually to FDA (or at shorter intervals as FDA may require), all information received concerning adverse dietary supplement experiences not reported pursuant to the serious adverse experience requirements. The Bill also authorizes FDA to require supplement manufacturers to conduct postmarket surveillance if there is a reasonable possibility that the use of the supplement by a significant number of consumers may result in serious adverse experiences.

Next, SB 722 amends the Federal Food, Drug, and Cosmetic Act by defining the term stimulant. A stimulant is any dietary ingredient that has a stimulant effect on the cardiovascular system or the central nervous system of a human by means of speeding metabolism, increasing heart rate, constricting blood vessels or causing the body to release adrenaline. If passed, all stimulant-containing dietary supplements would be subject to FDA premarket approval. FDA would have 180 days after receiving an application to approve or disapprove it.

Finally, SB 722 amends the Act to exclude a product that contains an anabolic steroid (including a substance that is chemically and pharmacologically related to testosterone, but not including estrogen, progestin or corticosteroid) from the definition of a dietary supplement.

The most worrisome effect of SB 722 is the shift in the burden of proof. Under DSHEA, it is FDA’s burden to prove that a product on the market is unsafe. With the serious dietary supplement adverse experience reporting requirements in SB 722, the burden of proof is shifted from FDA to the manufacturer of the product. Under SB 722 FDA can, based on a single serious adverse experience, require a manufacturer provide the agency with data to prove that the product is safe. If that data is insufficient, FDA can remove the produce from the market. The shift in the burden of proof effectively guts DSHEA in practice and in spirit.

Next, SB 722 will add unnecessary expense to manufacturer and distributors of dietary supplements. In cases where FDA suspects there is a reasonable possibility that the use of the supplement by a significant number of consumers may result in serious adverse experiences it can require a manufacturer to engage in postmarket surveillance. The preparation of such surveillance will be time consuming and costly. Under the Bill, manufacturers have 30 days to draft a surveillance plan and will likely have to hire qualified personnel to draft the plan and to conduct the surveillance.

Manufacturers and distributors of stimulant-containing dietary supplements face the added expense of having such products pre-approved by FDA. Manufacturers and distributors that receive a complaint of a serious adverse experience face the expense of providing FDA with proof that the product is safe.

Finally, SB 722 is redundant. FDA already has the authority conveyed by SB 722. Indeed, FDA has the authority to remove, seize, condemn and destroy products that are misbranded, adulterated or otherwise present an unreasonable risk of harm to the public. Under DSHEA a manufacturer cannot market a dietary supplement unless it is safe; if FDA determines that the product or an ingredient in the product is unsafe, it has statutory authority to remove it from the market. Further, FDA has statutory authority to regulate the types of ingredients that can be included in dietary supplements. Finally, the proposed current good manufacturing practices will become final rules in the not to distant future. Those regulations grant FDA broad authority and will address any outstanding safety issues in connection with dietary supplements.

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