Dietary Supplements

FDA To Ban Sale of Dietary Supplements Containing Ephedra

Is “re-regulation” of the dietary supplement industry on the horizon?
Bioterror detention for non-compliance?

In a precedent setting action the FDA announced on December 30, 2003 that it will issue a rule to ban the sale of dietary supplements containing ephedra. The FDA also said it is sending letters to 64 firms which distribute or manufacture dietary supplements containing ephedra telling them that the FDA will begin enforcing the ban as soon as the rule becomes final; thereby, apparently precluding any phase out of banned product inventories after that date.

The FDA, which for years has proposed restrictions on the marketing of dietary supplements containing ephedra, is basing its action on a RAND corporation study that the FDA commissioned. Based on the results of the study, the FDA has concluded that ephedra containing dietary supplements represent an “unreasonable risk of injury or illness” under the federal Food, Drug & Cosmetic Act. The letter to the distributors states that FDA will begin enforcing the rule 60 days after it becomes effective. The 60 day delay is to allow for congressional review or as it is more commonly called “congressional veto.” According to an FDA Q&A release, the proposed rule will be published in the Federal Register in “a few weeks” for public comment. The Q&A does not state when FDA anticipates that it will issue a final rule. In addition to the 60 day congressional veto period, completion of the rule making process will probably take several months.
Since 1997 the FDA has considered proposals to place limits on the use of ephedra in dietary supplements, but FDA action has been limited by the restrictions in the 1993 Dietary Supplement Health and Education Act, commonly known by its acronym DSHEA. Under DSHEA products marketed as dietary supplements are generally subject to a much lesser degree of FDA oversight than products that are marketed as food or drugs. Several public interest groups have vehemently opposed DSHEA and it is expected they will use ephedra as a spring board to call for broad changes in the law.

The FDA’s Q&A also stated that it did not classify ephedra containing dietary supplements as an “imminent hazard to the public health,” because the classification of a substance as an “imminent hazard” is subject to a much higher legal standard than the “unreasonable risk” classification, and the FDA was “less confident” that an action under the imminent hazard standard would be sustainable. Use of the “imminent hazard” standard would have expedited the rule making proceeding to ban ephedra’s use.

Comment:
Not addressed in the FDA’s materials is the possibility of the agency taking action under the administrative detention authority that was given it in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the “Bioterrorism Act”). Although the FDA has delayed at least until March 2004 final rules implementing its detention authority, such rules are not required by the Bioterrorism Act as a prerequisite for the FDA using its detention authority. As readers of prior issues of Food & Marketing Law Update know, the FDA’s detention authority is an in-house administrative action that does not require rule making or initial judicial approval. The standard for exercising this authority is stated in the Bioterrorism Act is that the FDA has credible evidence or information indicating that an article of food, which includes dietary supplements, presents a threat of Serious Adverse Health Consequences Or Death To Humans Or Animals, fondly known to us and the people who have seen Zackler & Associates' Bioterrorism Act presentation as SAHCODHA. The threat need not be related to bioterrorism. Whether or not anyone at FDA ever raised the issue of administrative detention, it’s pretty clear to us that although an “imminent hazard” might be SAHCODHA, an “unreasonable risk” is not.

 

FDA Issues New Policy Statement Concerning Health Claims on Dietary Supplements & Food

In a new effort to comply with the District of Columbia Court of Appeals decision in Pearson v. Shalala the FDA has issued a new policy statement concerning “qualified” health claims that can be put on the labels of dietary supplements and food products. In Pearson the Court held that the First Amendment limited FDA’s regulation of truthful health claims on the labels of dietary supplements.

Essentially, the FDA’s new policy has created a category of “enforcement discretion” for health claims that do not meet the FDA’s existing requirement that health claims be substantiated by “significant scientific agreement.” The new category is based on the “weight of the scientific evidence”. The FDA’s policy describes this test as: “The test is not whether the claim is supported numerically (i.e., whether more studies support the proposed claim than not), but rather whether the pertinent data and information presented in those studies is sufficiently scientifically persuasive.”

In order to trigger enforcement discretion, the health claim must be submitted to the FDA through its existing petition process for health claims. Presumptively, the FDA will exercise (non-) enforcement discretion, if it determines that although the claim is not supported by “significant scientific agreement,” it is supported by the weight of the scientific evidence. The FDA has reserved the right to later exercise enforcement discretion against a health claim if it determines that the weight of subsequent scientific evidence shifts against the claim.

Don’t rush to file your petition with the FDA. The Office of Nutritional Products, Labeling and Dietary Supplements, which will be administering the program, has stated that qualified claims will not be reviewed by the agency until an implementation phase is completed that could take as long as six months.

This rather peculiar policy is based on the FDA’s position that the FD&C Act only allows it to approve health claims that meet the significant scientific agreement test and therefore, the FDA cannot “approve” health claims that a meet a lesser standard.

It remains to be seen whether this new policy will satisfy the plaintiff’s contention that prior FDA initiatives failed to comply with the requirements of Pearson. Even if the policy itself meets Pearson’s requirements, there will probably be issues whether the FDA is honestly administrating the new policy. We expect more visits to the courthouse before this is all over.

The FDA’s new policy also stated that it is adopting the FTC’s “reasonable consumer” standard for determining whether a claim is misleading instead of the statutory “misleading in any particular” standard. We’ll have to wait and see how the FDA interprets this new standard and what effect, if any, it has on FDA enforcement actions. However, it’s a very good bet that your marketing department's definition of a reasonable consumer won't be the same as the FDA's.

Meanwhile, the FDA has approved a new health claim for products with D-tagalose, which is commonly called tagalose. Tagalose has been added to the “does not promote tooth decay” health claim that the FDA has already approved for products sweetened with sugar alcohols such as sorbitol. As with many FDA regulations there is a catch. Because tagalose is classified as a sugar, products that contain it cannot be labeled as “sugar free.” On the other hand, products which contain tagalose will not have to list their sugar alcohols content in the Nutrition Facts. The amended regulation approving the new health claim for tagalose contains several examples of model claims.

Zackler & Associates can advise you concerning utilization of the new FDA policy to expand marketing opportunities for your food and dietary supplements.

 

NATIONAL FOOTBALL LEAGUE BANS EPHEDRINE USE

The National Football League has banned the use of the dietary supplement ephedrine by its players. The FDA has linked the stimulant to at least 80 deaths.

Under the ban, which will be included in the league’s anti-steroid policy, players will be subject to year-round random testing for ephedrine. Further, the league will ban teams and players from endorsing manufacturers or distributors of ephedrine-based products. Many athletes have used ephedrine-based supplements for both weight loss and energy boosting. The National Collegiate Athletic Association and the International Olympic Committee have long banned the use of ephedrine supplements by its athletes.

 

STARBUCKS ACCUSED OF SPIKING TEA WITH EPHEDRINE

The Council for Education and Research on Toxics, a Los Angeles based public interest group, has filed suit against Starbucks Corp., claiming that Starbucks has secretly spiked its Tazo Chai Tea with ephedrine since 1996. The lawsuit claims violations of the California Health & Safety and Business & Professions Codes. The Council seeks to enjoin Starbucks from adding ephedrine to the tea and to force Starbucks to pay restitution to the State of California.

While ephedrine is legal for use in dietary supplements, the FDA has not approved ephedrine’s use in food or beverage products under its “Generally Regarded As Safe (GRAS)” regulations.

Starbucks has strongly denied the allegations. “We have tested Chai Tea for the presence of ephedrine and the results have been conclusively negative,” said Starbucks spokesperson Audrey Lincoff. “Ephedrine has never been used as an ingredient in Tazo’s Chai Tea or any other Tazo product. There are no basis to the claims raised by the plaintiff and we intend to vigorously defend the lawsuit.”

 

FDA ISSUES WARNING OVER LIPOKINETIX

The FDA has warned consumers to immediately stop using the dietary supplement Lipokinetix®, marketed by Syntrax Innovations, Inc. The warning was issued after FDA received multiple reports of liver damage from consumers who were taking the supplement. Lipokinetix is marketed as a weight loss product. Its contains the ingredients norephedrine, caffine, yohimbine, diodothyronine and sodium usniate. All reported liver injuries appeared in consumers between the ages of 20 and 32. Onset of damage took as long as three months to occur. Symptoms included nausea, weakness or fatigue, abdominal pain or any change in skin color.