The year 2003 witnessed an increasing level of involvement by the U.S. Congress in matters dealing with the regulation, quality, safety and claims for herbs and other dietary supplements. In March 2003, Sen. Richard Durbin (D-IL) introduced the Dietary Supplement Safety Act (S. 722) into the U.S. Senate proposing significant changes to the regulation of herb and dietary supplements. In July, the House Committee on Energy and Commerce held a two-day hearing on safety issues related to the controversial herb ephedra (Ephedra sinica Stapf, Ephedraceae). In July, Senators Tom Harkin (D-IA) and Orrin Hatch (R-UT) introduced the DSHEA Full Implementation and Enforcement Act of 2003 (S. 1538), to promote full enforcement of the Dietary Supplement Health and Education Act of 1994 (DSHEA). Then, in October Rep. Susan Davis (D-CA) introduced the Dietary Supplement Access and Awareness Act (HR 3377) which proposes to prohibit "high-risk" supplements to minors and other restrictions on supplements. In November, an amendment was attached to the Agriculture Bill that would grant the U.S. Food and Drug Administration (FDA) $1 million in additional funding to enforce existing provisions of DSHEA, including $500,000 for enforcement of provisions related to ephedra. Four other bills have implications for herbs and other supplements (Table 1).
At the close of Congress in December, these bills were still "on the table," although it is possible that they will be amended or given another designator number when Congress reconvenes in January 2004. The following is a brief summary of each bill and their potential impact on the herb and dietary supplement industry.
Dietary Supplement Safety Act (S 722)
DSHEA Full Implementation and Enforcement Act (S 1538)
Dietary Supplement Access & Awareness Act (HR 3377)
Amendments to Agriculture Bill for $1.25 million to FDA for DS enforcement
The Dietary Supplement Information Act (HR 724)
The Access to Medical Treatment Act (HR 2085, S 1410)
The Dietary Supplement Tax Fairness Act (HR 2627)
The Anabolic Steroid Control Act of 2003 (S 1780)
Davis, Waxman, Dingell
Durbin, Harkin, Hatch
Burton, Pallone, Paul
Biden, Grassley, Harkin, Hatch
Dietary Supplement Safety Act
Among numerous other provisions Sen. Durbin’s bill (S. 722) would require FDA pre-approval for any substance in a supplement that meets the proposed definition of "stimulant" (see Table 2). It would also require mandatory adverse event reporting for serious adverse events and a FDA review and audit of such events. A serious adverse dietary supplement experience, as defined by the Act, means an experience that results in (1) death; (2) a life-threatening condition; (3) inpatient hospitalization or prolonged hospitalization; (4) a persistent or significant disability or incapacity; (5) a congenital anomaly, birth defect, or other effect regarding pregnancy, including premature labor or low birth weight; or (6) requires medical or surgical intervention to prevent one of the outcomes described above.1
S. 722 is primarily a response to mounting concerns in Congress and elsewhere over the safety of ephedra as well as other controversial ingredients that have been misrepresented and sold as dietary supplements (e.g., androstenedione, a.k.a. andro).
In his press release announcing the submission of the bill, Sen. Durbin said, "A small number of products – primarily stimulants and steroids masquerading as herbal compounds – have proven lethal to consumers. My bill provides that before you can sell these high-risk products, you must prove they are safe. This bill will save lives and restore America’s confidence in the use of dietary supplements."2
However, some herb industry leaders are not so sure. "By requiring that all stimulants, except conventional foods such as coffee, tea, etc. as well as OTC drugs containing caffeine, be subjected to FDA pre-market approval procedures, interpretation of this provision suggests that even green tea (Camellia sinensis (L.) Kuntze, Theaceae) dried extract in dietary supplement dosage forms would be subject to FDA pre-market approval – a scenario which is both absurd and entirely unnecessary," Loren D. Israelsen, executive director of the Utah Natural Products Alliance (UNPA), a trade group representing large supplement manufacturers, primarily in Utah, wrote to the author on Jan. 6, 2004.
In an email sent in July 2003 to UNPA stakeholders, Israelsen claims that the provisions in S. 722 are "a dramatic and punitive attempt to rewrite DSHEA and impose unnecessary and impractical requirements on many safe and useful supplements. … In particular, the bill proposes what appears to be extraordinarily burdensome requirement for adverse event reporting, which has no precedent under food or drug law. Not only is this requirement punitive but it would subject virtually every supplement company to tremendous economic and legal liability in trying to comply with these proposed provisions."3
In an open letter, constitutional attorney Jonathan Emord called S. 722 "redundant." He wrote, "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 too distant future. Those regulations grant FDA broad authority and will address any outstanding safety issues in connection with dietary supplements."4
Predictably, S. 722 is being opposed by industry trade groups – American Herbal Products Association (AHPA), the Council for Responsible Nutrition (CRN), the National Nutritional Foods Association (NNFA), UNPA, as well as some major supplement manufacturers – all of whom have joined a coalition to work in Congress to oppose S. 722 and S. 3377 and support S. 1538. The newly formed Coalition to Preserve DSHEA (CPD) is being run chiefly by large supplement companies, with trade organizations as nonvoting members. CPD reportedly will be spending funds on specific, earmarked projects but will have no ongoing infrastructure and no administrative overhead, according to NNFA Executive Director/CEO David Seckman.5
1. Adverse Event Reports (AERs). All serious adverse experiences with dietary supplement (DS) are to be investigated and reported to FDA within 15 days. FDA will conduct a clinical evaluation of each serious AER. All DS manufacturers must annually submit a report to the FDA with respect to all AERs received by the company. Sources of AERs can include the following: direct from consumers plus “any other means” (i.e., information without regard to the source, foreign or domestic, derived from these sources: commercial marketing experience, post-marketing investigations, post-marketing surveillance, clinical studies, case reports in the medical literature, and unpublished scientific papers, presumably those in possession of the company, that is, those that the company may have sponsored but not published).
2. Post-market Surveillance. The Department of Health and Human Services (HHS) and/or the FDA may order a company to conduct post-market surveillance if they determine there is a reasonable possibility that a use or expected use of a DS by a significant number of consumers may result in serious adverse experiences.
3. Safety reviews for possibly dangerous DS. A clinical evaluation by FDA on one or more serious AERs may indicate that a DS or a dietary ingredient (DI) appears to present a significant or unreasonable risk of illness. HHS/FDA may require manufacturers of the DS or DI to submit to FDA data demonstrating that the DS or DI is safe in order for the DS/DI to remain on the market.
4. Approval/disapproval of continued marketing. As soon as practicable, FDA shall review the data and determine if the DS is safe and if continued marketing is approved, or, whether the DS is unsafe and continued marketing is disapproved.
5. Stimulants. The newly proposed definition of “stimulant” is a DI that has a stimulant effect on the cardiovascular system or the central nervous system of a human by any means, including speeding metabolism, increasing heart rate, constricting blood vessels, and/or causing the body to release adrenaline.
6. Pre-market approval for stimulants. No one shall sell a DS containing a stimulant unless an FDA approval of that DS is in effect. FDA shall approve applications for pre-market approval for a stimulant DS if the manufacturer demonstrates the DS is safe under ordinary or frequent conditions of use. In the case of a combination of stimulants in a DS, FDA shall consider the interaction of the various stimulants to assess and conclude a safety determination. This law does not affect caffeine used as a food or a drug. The provisions in this section will take effect 2 years after the date of enactment of the act.
7. Steroid Precursors. Section 201 of the Food, Drug and Cosmetic Act would be amended to read, “Other than tobacco or a product that bears or contains an anabolic steroid (including a substance that is chemically or pharmacologically related to testosterone but not including an estrogen, progestin or corticosteroid.)” That is, the definition of “dietary supplement” would automatically preclude tobacco (as is currently the case in DSHEA) plus anything that would be interpreted as an “anabolic steroid,” which is defined as “Anything that promotes muscle growth or is advertised or used to promote muscle growth.” Such products would be subject to regulation under the Controlled Substances Act.
DSHEA Full Implementation and Enforcement Act of 2003
On July 31, Senators Harkin and Hatch, the principle sponsors of DSHEA (with former Rep. Bill Richardson [D-NM]), introduced the DSHEA Full Implementation and Enforcement Act of 2003 (S. 1538) (Table 3).6 The bill is a response to concerns expressed by industry associations that many of the problems with dietary supplements heralded by the media and highlighted in congressional hearings are the result of FDA’s inadequate enforcement of DSHEA. According to the NNFA’s Seckman, S. 1538 is basically a funding bill for 2004.5 The proposed law would increase funding to the FDA to more fully enforce the provisions of DSHEA ($20 million for fiscal year 2005, growing up to $65 million in 2008). S. 1538 also proposes $30 million in funding in 2004 for the Office of Dietary Supplements (ODS) at the National Institutes of Health, an agency created by DSHEA "for expanded research and development of consumer information on dietary supplements" and "such sums as may be necessary for each of the fiscal years 2005 through 2008." The bill also proposes that the Secretary of the U.S. Department of Health and Human Services submit to Congress an annual "Accountability Report on the Regulation of Dietary Supplements," which would require that FDA provide Congress with a detailed accounting of its activities and resources spent in the area of regulating dietary supplements (DS).
1. Increased funding for FDA to implement DSHEA: • Additional $20 million in fiscal year 2004, growing to $65 million in 2008.
2. Increased funding for Office of Dietary Supplements (ODS) for research and consumer education on dietary supplements. • Additional $30 million in 2004 with further monies incrementally until 2008.
3. The Secretary of HHS will submit to Congress an annual “Accountability Report on the Regulation of Dietary Supplements,” which will include the following provisions on the implementation and enforcement of DSHEA:|
1) The total funding and number of full-time equivalent personnel in the FDA dedicated to: a) dietary supplement (DS) regulation over the prior fiscal year. b) administering adverse event reports (AERs) as they relate to DS regulation over the prior fiscal year. c) enforcement of DS labeling and claims requirements over the prior fiscal year and an explanation of their activities. d) good manufacturing practice (GMP) inspections of DS manufacturers over the prior fiscal year and an explanation of their activities.
2) The number of GMP inspections of DS manufacturers by the FDA over the prior fiscal year and a summary of the results.
3) The number of new ingredient reviews and safety reviews related to DS and the results of those reviews.
4) An explanation of all enforcement actions taken by the FDA and HHS related to dietary supplements over the prior fiscal year, including the number and type of actions.
5) The number of DS claims for which the FDA requested substantiation from the manufacturer over the prior fiscal year, and the agency’s response.
6) The number of DS claims determined to be false, misleading, or nonsubstantiated by the FDA over the prior fiscal year.
7) The research and consumer education activities supported by the ODS.
8) Any recommendations for administrative or legislative actions regarding the regulation of DS.
9) Any other information regarding the regulation of DS determined appropriate by the Secretary of HHS or the Commissioner of FDA.
Dietary Supplement Access and Awareness Act
On October 28, Rep. Susan Davis introduced the Dietary Supplement Access and Awareness Act (HR 3377), which, among other provisions, would prohibit the sale of DS to minors under the age of 18 if such supplements were deemed by the FDA to pose a significant risk to minors (Table 4).7 The bill is co-sponsored by Representatives John Dingell (D-MI) and Henry Waxman (D-CA), two powerful representatives who have long held critical views of the supplement industry. The bill proposes to classify DS into two categories – those that are nutritionally based conventional supplements like vitamins and minerals and those others that are not normally associated with nutrition (e.g., herbals). The proposed act would deal with the latter category, not vitamins and minerals. In one of the most controversial provisions, the bill would require that manufacturing companies submit adverse event reports received for all supplements containing herbs, amino acids and other related ingredients two times annually to the FDA. Industry leaders characterize this part of the bill as burdensome, unreasonable, and unprecedented, particularly with respect to requirements for the pharmaceutical industry.
In a bulletin to AHPA members, AHPA President Michael McGuffin wrote, "AHPA has long stated its belief that submission of serious adverse event reports should be mandatory for supplements, but it appears as if this bill fails to provide the protections to industry that are established by law for adverse event submissions by drug companies. Also, the idea of a product registration is one that may deserve discussion and cost evaluation, but Representative Davis should first explain why the proposed semi-annual burden for supplements should exceed the annual burden for drugs. In addition, the subjective nature of FDA decision making for each of their proposed new authorities must be challenged."8
The bill was referred to the House Committee on Energy and Commerce, chaired by Rep. Billy Tauzin (R-LA), who held the hearing on ephedra in July, and who later said his vote for DSHEA in 1994 was an error.
|1. Applies only to herbs, amino acids, and other ingredients described in DSHEA as “dietary substance(s) used by man to supplement the diet by increasing the total dietary intake”; vitamins and minerals excluded. 2. All manufacturers and processors of these dietary supplements must provide to FDA, and update every 6 months, the following: a) a list of all products; b) labeling for each product; c) a listing of all “major ingredients ... including active ingredients, as applicable”; d) at the discretion of FDA, a quantitative listing of all ingredients; 3. Manufacturers and distributors of these products, unless specifically waived by FDA, must report serious adverse events to FDA within 15 days of receipt, to investigate any such reports, and to maintain certain records; 4. FDA would have new authority to order a manufacturer to conduct post-market surveillance of supplements for which there is “a reasonable possibility...[of] serious adverse health consequences”; 5. FDA would have new authority to require a manufacturer to demonstrate safety of a supplement if the agency has “reasonable grounds for believing” that the supplement presents a significant or unreasonable risk of illness or injury or is an imminent hazard to public health or safety; 6. FDA would have new authority to establish criteria for determining that a supplement may pose a significant risk to minors and for deeming the act of selling such product to minors as misbranding. 7. The bill would provide funding to educate health professionals on reporting adverse health experiences associated with DS to FDA and to educate consumers about informing health professionals on the DS and drugs they take. 8. The bill would also change the Food, Drug and Cosmetic Act, as amended by DSHEA, which states that the burden of proof is on the federal government to demonstrate that a supplement is adulterated or unsafe.|
Other bills introduced into Congress in 2003 may directly or indirectly affect herbs and other dietary supplements. Most of these bills are in committee and have an uncertain fate at this time.
• The Dietary Supplement Information Act (HR 724). This bill was also introduced on February 12 by Rep. Davis. It intends to require registration of all dietary supplement products with FDA, establish an AER system requiring annual reporting of minor AER, establish broad inspection authority by FDA of supplement companies’ records, and require the 1-800-MEDWATCH phone number be placed on all supplement labels (a move previously required by the State of Texas for all ephedra products marketed in that state).9 The reporting of minor AERs is currently a requirement for new drugs only, and is not required for over-the-counter drugs, and, reportedly this bill would not guarantee dietary supplement manufacturers the protections that current federal regulations give to pharmaceutical companies with similar obligations. The bill has no co-sponsors and has been referred to the House Committee on Energy and Commerce.10
• The Access to Medical Treatment Act (HR 2085 & S 1410). These bills have been introduced in the House by Rep. Peter DeFazio (D-OR) on May 1411 and the Senate by Sen. Harkin on July 15.12 If passed, the legislation would allow treatment by a licensed healthcare practitioner using any medical modality that the patient requests, including a treatment that is not approved, certified, or licensed. It would require a practitioner administering such treatment to report both the adverse and positive effects observed while administering an unconventional medical treatment for a life-threatening medical condition. The House bill currently has four co-sponsors and has been referred to the Committee on Energy and Commerce; the Senate version also has four co-sponsors and has been referred to the Committee on Health, Education, Labor and Pensions.
• The Dietary Supplement Tax Fairness Act (HR 2627) was introduced on June 26 by Representatives Dan Burton (R-IN), Frank Pallone (D-NJ), and Ron Paul (R-TX). The bill would amend the Internal Revenue Code to treat amounts paid for foods for special dietary use, dietary supplements, and medical foods as medical expenses for purposes of the medical expense deduction. It currently has three co-sponsors and has been referred to the Committee on Ways and Means.13
• The Anabolic Steroid Control Act of 2003 (S 1780) was introduced October 23 by Senators Joseph Biden (D-DE) and Hatch.14 The bill applies to substances that, once ingested, metabolize into anabolic steroids and "would amend the Controlled Substances Act to clarify the definition of anabolic steroids and to provide for research and education activities relating to steroids and steroid precursors." The intent of the bill is to treat the hormone androstenedione (andro) and similar chemicals as controlled substances. While this might appear to be a relatively simple issue on the surface, the question that arises for herbs is whether an herbal material containing natural sterols and related compounds might be inappropriately relegated to the status of controlled substances. The bill has three co-sponsors and is currently referred to the Judiciary committee. The bill appears to be strongly supported by a large coalition of medical and sports organizations concerned about the availability of dietary supplements containing anabolic steroid precursors and ephedra.
At this time it is not clear which of these bills, if any, will prevail in the ensuing political process that has the inevitable effect of subtly and often significantly changing the intentions of the initial sponsors of the bills. Sen. Durbin has indicated that he is not interested in accepting any significant changes or compromises to his bill and would rather reintroduce it in the new session of Congress, which started this year. As for the future of the Hatch-Harkin bill, a step in its intended direction has already taken place: On November 6, Senators Harkin and Hatch, with the support of Sen. Durbin, were successful in getting a rider added to the Agriculture Bill in which $1 million in new funding was appropriated to FDA for enforcement of DSHEA. As a compromise to enlist the support of other members, another provision sponsored by Sen. Durbin, and co-sponsored by Harkin and Hatch, was attached to the bill providing for an additional $250,000 to be earmarked for FDA enforcement actions related directly to ephedra.
Regardless of the outcomes of the legislative process, it is quite clear that powerful forces are converging with the intention of changing the way dietary supplements, particularly herbs, are regulated. One group wants to see full enforcement of the existing regulations while the other wants to seriously amend the existing regulatory landscape. If either or both prevail, the future of herbal regulation will definitely be different from the experiences of the past decade.
1. 108th Congress. US Senate. Dietary Supplement Safety Act of 2003 (S 722). Mar. 26, 2003. Available online: <http://thomas.loc.gov>.
2. Durbin R. Durbin moves to prevent sale of dangerous dietary supplements like ephedra: bill would require manufacturers to prove stimulants are safe prior to sale, would no longer allow steroids to be considered dietary supplements, and would bolster FDA’s enforcement authority [press release]. Mar. 26, 2003. Available online: <http://durbin.senate.gov/~durbin/new2001/press/2003/03/2003328821.html>.
3. Israelsen LD. Email to author, July 2003.
4. Emord J. Dietary Supplement Safety Act of 2003 [letter], undated.
5. Seckman D. Personal communication to author, Dec. 15, 2003.
6. 108th Congress. US Senate. DSHEA Full Implementation and Enforcement Act of 2003 (S 1538). July 31, 2003. Available online: <http://thomas.loc.gov>.
7. 108th Congress. US House of Representatives. Dietary Supplement Access and Awareness Act (HR 3377). Oct. 28, 2003. Available online: <http://thomas.loc.gov>.
8. AHPA Update. Waxman/Dingell/Davis introduce new supplement bill legislation: targets herbs and other non-nutritive ingredients. Silver Spring, MD: American Herbal Products Association. October 31, 2003.
9. 108th Congress. US House of Representatives. Dietary Supplement Information Act (HR724). Feb. 12, 2003. Available online: <http://thomas.loc.gov>.
10. Anon. 2003 – the year in review: regulations and legislation. The AHPA Report. Jan. 2004.
11. 108th Congress. US House of Representatives (HR 2085). Access to Medical Treatment Act. May 14, 2003. Available online: <http://thomas.loc.gov>.
12. 108th Congress. US Senate. Access to Medical Treatment Act (S 1410). July 15, 2003. <http://thomas.loc.gov>.
13. 108th Congress. US House of Representatives. The Dietary Supplement Tax Fairness Act (HR 2627). June 26, 2003. Available online: <http://thomas.loc.gov>.
14. 108th Congress. US Senate. Anabolic Steroid Control Act of 2003 (S 1780). Oct. 23, 2003. Available online: <http://thomas.loc.gov>.
15. Israelsen LD. DSHEA 10 years later. What happened? Las Vegas, NV: National Nutritional Foods Association Annual Convention; July 2003.