FDA & USDA Related Articles

FDA Reopens Comment Period for Nutrient Content & Health Claims

The FDA has published a Federal Register notice for comments concerning proposed changes in the requirements for nutritional and health claims on the labels of food products. This request for comments relates to proposals dating back to 1995 concerning the requirements for health and nutritional claims. The FDA has asked for comments on the following topics.

  • FDA regulations currently require that a product contain at least 10% or more of a nutrient’s daily reference value (DRV) per serving in order to make the claim that the food is a “good” source of that nutrient (e.g., vitamin A or fiber). The FDA is considering two possible exemptions to the 10% requirement. One proposal is to exempt fruit and vegetable product and enriched bread and cereal products. The other proposal would exempt products whose DRV caloric percentage does not exceed the DRV percentage of the nutrients. For example, a food that contains 8% of the DRV for vitamin A per serving could be labeled as a good source of vitamin A if the food’s calorie DRV per serving does not exceed 8%.
  • FDA regulations currently prohibit the use of health claims on foods that exceed certain levels of “bad” nutrients such as cholesterol or fat. The FDA is considering an alternative of allowing health claim to be made on otherwise disqualified foods if affirmative disclosure statements are also made concerning the “bad” nutrients in the food.
  • The use of the word “may” in health claims as an alternative to the use of disclaimers in qualified health claims which state that health properties of a food can be dependant upon other factors such as exercise. The FDA is also seeking comment on elimination of the word “may” from unqualified health claims in order to correctly represent to consumers that the unqualified health claim is based on significant scientific agreement.
  • Currently the terminology that can be used to describe a product’s nutritional benefits is limited to specific words such as “good source,” “high,” “little,” and “contains.” Terms that are not expressly allowed by FDA regulations have to be approved by the FDA through a petition process. The FDA wants to see if the restrictions on the approved terminology can be loosened without creating significant consumer confusion.
  • FDA has requested consumer study data pertaining to the use of “abbreviated” health claims. Under the proposal the various qualifiers that now must appear in a health claim could be moved to a separate panel on the label. The FDA has also requested comment on how the use of abbreviated health claims may impact the use of “may” in connection with qualified health claims as discussed above.

The comment period closes on July 6, 2004.

 

BIOTERROR UPDATE: FDA Issues Final Detention Rule

The FDA has issued its final rule pertaining to the detention authority given it under the Bioterrorism Act of 2002. The rule, which is similar to the proposal first put forth by the FDA in 2003, provides:

  • FDA can now administratively detain any food for up to 30 days (7 days for perishable food) if an FDA employee has reason to believe that the food presents a threat of a “serious adverse health consequence or death to humans or animals,” also called SAHCODHA.

  • Any detention order must be approved by an FDA District Director prior to issuance

  • The SAHCODHA threat need not be due to an act of terrorism (e.g., undeclared allergens in a food could be the basis for detention).

  • Under the Bioterror Act, food includes dietary supplements and food contract substances such as packaging. It does not include meat or poultry products that are subject to the exclusive jurisdiction of the USDA

  • The FDA may order the food to be detained on site or at a “secure facility.” In either case, while under detention the food cannot be moved for any purpose, including destruction, without FDA authorization.

  • Once a detention order is issued, the FDA will have four days to commence a federal court procedure to seize perishable detained food. (When food is detained, it remains the property of the owner. Seizure essentially transfers legal title to the food from the owner to the government.)

  • The rules provide for the appeal of a detention order. Appeals notices are filed with FDA District Director and an FDA Regional Director will hear the appeal. Appeals of detention orders for perishable foods must be filed within 2 days and appeals of detention orders for non-perishable foods must be filed within 10 days.

  • We anticipate that every time a detention order is issued, FDA inspectors will also ask for production of all tracking records. Based on these records, the FDA may issue additional detention orders to ingredient suppliers and/or customers the food processor or distributor whose products have been detained.

With the issuance of this final rule, we are still waiting for the FDA to issue a “final” or “interim final” rule pertaining to the Act’s tracking requirements. The FDA has previously issued “interim final” rules pertaining to the two other sections of the Bioterrorism Act that affect FDA regulation, namely facility registration and import pre-notification.

 

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.