In the dietary supplement industry, most people are quite familiar with the Food and Drug Administration and the Federal Trade Commission. In broad terms, the FDA governs and monitors ingredients, safety, manufacturing and labeling of products, while the FTC monitors product advertisements whether in print ads, press releases, infomercials, testimonials, or on Web sites, radio or TV. But there is also a third agency to watch when marketing certain dietary supplements or foods: the Drug Enforcement Agency, with information available at www.dea.gov.
One recent example of DEA action is the proposed prohibition on selling foods containing even small amounts of hemp or cannabis, or more specifically, the active constituent, THC.
There is a generally cooperative relationship between the DEA and the FDA, with a great deal of collegial exchange and regular meetings between the DEA's Office of Diversion Control and the FDA's Center for Drug Evaluation and Research and other divisions. In addition, the DEA sometimes requests a formal opinion letter from the FDA; for example, about 18 months ago the DEA formally requested the FDA's opinion on the use of ephedrine hydrochloride in dietary supplements. The determination that EHCl was a drug led to a large seizure of weight loss supplements. Often the FDA and the DEA will join forces in a seizure action.
The FDA also advises the DEA as to which drugs should be "scheduled." While enforcement of the U.S. Controlled Substances Act is the responsibility of the DEA, the FDA also plays a critical role, primarily at the new drug application stage. The FDA flags new drugs that have the potential for addiction and abuse, based on all the available scientific evidence.
As the federal authority for regulating all controlled and noncontrolled prescription drugs from a health and safety perspective, the FDA's authority is contained in the federal Food, Drug and Cosmetic Act. Thus, controlled substances are subject to regulation by both the FDA and the DEA. Together, the FFDCA and the CSA provide a framework for safeguarding the health and safety of consumers; and collaboratively, the DEA and the FDA strive for consistent application of federal laws.
GHB—Dietary Supplement Or Date-rape Drug?
Starting in 1997 and through 2000, the FDA warned the public about a group of products sold as dietary supplements for bodybuilding, weight loss, mood enhancement and sleep inducement. These products have been determined to pose a significant public health hazard. They are chemically related to gamma butyrolactone and 1,4 butanediol, which are commonly used in the production of industrial chemicals such as cleaners, adhesives and paint thinner. When ingested, these substances, plus gamma hydroxybutyric acid, can generate feelings of sedation, or euphoria and intoxication. They can also cause dangerously low respiratory rates leading to respiratory distress, unconsciousness to the point of coma, vomiting, seizures and even death.
These substances also increase the effects of alcohol and are even more dangerous when consumed with other central nervous system depressant drugs. Because of these effects, GHB, GBL and BD have been used in drug-facilitated sexual assault and other crimes of violence—thus the name "date-rape drug." All three of these drugs are odorless and invisible when dissolved in water, often making victims unaware that they have been drugged.
While these products are listed as party drugs on Internet sites, advertised in muscle-building magazines and sold as dietary supplements, the FDA considers many of them to be unapproved new drugs and has conducted seizures to prevent their sale to consumers, and any further illnesses or deaths.
GBL and 1, 4 BD were once readily available as dietary supplements with product names such as Revivarant, Blue Nitro, Insom-X, Remforce, Firewater, Invigorate, SomatoPro, Serenity, ThunderNectar and NRG3. But the scientific community has repeatedly warned against using these GBL and BD products for supplement purposes because of the drugs' toxic effects. GBL, GHB and BD have been linked to at least 122 serious illnesses reported to the FDA, including three deaths. In February 2000, the FDA issued a warning against dietary supplements containing GBL and BD and asked for a voluntary recall of all such products.
At least one death and likely numerous assaults can be attributed to drugs sold by individuals recently arrested in a DEA enforcement action called "Operation Webslinger"—comparable to the joint FDA/FTC Web sting called Operation Cure.all. The DEA reported that Operation Webslinger had a swift and national impact on date-rape drug availability, with drug users conceding in chat rooms that the operation had brought "an end to an era" in Internet drug trafficking of such products. But the evening news demonstrates that the date-rape drug is, sadly, still occasionally in use.
HGH Must Promote Human Growth Medically
Many human growth hormone dietary supplements are on the market, most of them "precursor-HGH," and this is another substance for which the FDA and the DEA combine enforcement powers. What many in the supplements industry don't realize is that HGH is a drug to treat conditions like stunted growth, and is not to be used as a supplement for massive muscles. Precursors to HGH for anti-aging are technically legal as dietary supplements, although actual hormones are not. But beware of the real thing: The distribution of HGH (1) without a prescription, and (2) which does not have an approved new drug application under Section 505 of the FDCA, is a felony. Section 303 (f) of the act provides that:
- Except as provided in paragraph (2), whoever knowingly distributes, or possesses with intent to distribute human growth hormone for any use in humans other than the treatment of a disease or other recognized medical condition and pursuant to the order of a physician, is guilty of an offense punishable by not more than 5 years in prison, such fines as are authorized by title 18 of the U.S. Code, or both.
- Whoever commits any offense set forth in paragraph (1), and such offense involves an individual under 18 years of age, is punishable by not more than 10 years imprisonment, such fines as are authorized by title 18, or both.
- Any conviction for a violation of paragraphs (1) and (2) of this subsection shall be considered a felony violation of the Controlled Substances Act for the purposes of forfeiture under section 413 of such Act.
- As used in this subsection, the term "human growth hormone" means somatrem, somatropin or an analogue of either of them.
- The Drug Enforcement Administration is authorized to investigate offenses punishable by this subsection.
Note that this last section provides that offenders will be facing both agencies, the FDA and the DEA.
New Legislation Targets Steroid Precursors
"Anabolic steroid" is defined by federal regulation (21 CFR §1300.01) as "any drug or substance, chemically and pharmacologically related to testosterone, . . . that promotes muscle growth." In the 1980s and '90s, abuse of anabolic steroids, particularly by young athletes, became a national problem, including products advertising that actual testosterone was included. Trafficking in steroids had become increasingly common, and as the market expanded, use of steroids was seen in younger and younger populations, with sources including doctors, trainers and foreign suppliers. Even in 1989, a Government Accounting Office report on the problem included one survey indicating that 20 percent of athletes in five colleges surveyed used steroids. It also reported on the significant side effects of steroid use, and thus the GAO supported federal and state efforts for more control over steroid distribution and use.
However, a recent problem for some dietary supplement manufacturers and marketers is that some members of Congress want to greatly expand the powers of the Anabolic Steroid Enforcement Act by including even the most distant of precursors, many of them permissible anti-aging nutrients. House Resolution 207, the "Anti-Andro Bill," was introduced Jan. 7 by Reps. John Sweeney, R-N.Y., and Tom Osborne, R-Neb., with seven co-sponsors. (Osborne is a former University of Nebraska football coach). This piece of legislation seeks to amend the CSA by reclassifying testosterone precursors as controlled substances through automatically adding them to the Anabolic Steroid Control Act. This resolution would not limit sale by age, or even make such substances prescription only. Instead, as controlled substances, HR 207 would make it illegal for people of all ages to sell or buy supplements containing any precursor of a steroid, no matter how safe.
The issue, from the perspective of dietary supplement producers, is that the legislation is too broad, reclassifying all precursors and metabolites of steroids no matter how indirect or far removed from actual controlled substances—even six degrees of separation. The authority to add new substances to controlled substances schedules had been in the hands of the U.S. attorney general on a case-by-case basis founded on scientific review. By circumventing this procedure, HR 207 attempts to reclassify all precursors by a blanket act of Congress. It would outlaw many well-known and safe substances like DHEA, used not by young bodybuilders but by mature Americans for anti-aging. Specifically, many dietary supplements contain DHEA and 7-Keto DHEA (a mere metabolite of a steroid). If eventually the bill passes, many supplement products would need to be reformulated.
Although HR 207 seems to be dying in committee, a version of it could be resurrected in the next legislative session. That should be carefully watched by members of the supplement industry as yet another bill or amendment that would undermine the Dietary Supplement Health and Education Act—whether this is the goal or not.
Susan D. Brienza is an attorney in the Denver office of the Washington, D.C.-based law firm Patton Boggs LLP. She specializes in regulatory compliance, FDA law (including DSHEA) and FTC law. She may be reached at [email protected].
This column is not meant and should not be construed as a legal opinion or legal advice, but rather is intended to provide general principles and some examples as to various aspects of FDA, FTC and USDA law.
Natural Foods Merchandiser volume XXIV/number 7/p. 34