Nutraceutical Corp again challenges ephedra ban

By Clarisse Douaud

- Last updated on GMT

Nutraceutical Corporation is not giving up its fight for banned
herbal, ephedrine, and has filed a petition for rehearing in front
of the entire tenth circuit of the US Court of Appeals, following a
federal appeals court decision in August.

The decision pendulum has been swinging back and forth over the controversial sports performance and weight loss herbal. A Utah judge blocked FDA action against Nutraceutical in April 2005, which a federal appeals court then overturned in August.

Nutraceutical's latest petition specifically faults the three-judge federal appeals panel for using "the same risk-benefit comparison standard in post-market review of dietary supplements that is reserved for pre-market review of drugs."

The ongoing controversy over ephedra, stemming from case reports linking the herbal with serious adverse events, has given critics of the supplements industry ammunition. Unlike pharmaceuticals, which must go through a series of pre-market approvals, finished dietary supplements need no pre-market approval. Under the Dietary Supplement Health and Education Act (DSHEA), which is part of the Food and Cosmetics Act, only ingredients not marketed in the US before October 1994 must be approved by the FDA before use in consumer products.

The industry has indicated that supports measures to protect consumers within the existing framework, and most major players have expressed their support of a recently introduced bill that would make serious adverse events reporting to the FDA by companies mandatory.

In her judgement in April 2006, Judge Tena Campbell sided with Utah-based Nutraceutical that the FDA did not prove a daily dosage of 10mg or less of ephedra results in an unreasonable risk of illness or injury.

But the FDA appealed this decision and, in August, the US Circuit Court of Appeals in Denver came down on the FDA's side.

In its new appeal, Nutraceutical argues the FDA's assessment of "unreasonable risk" is too rigid and gives the agency license to declare any dietary ingredient adulterated.

The company also challenges the court's interpretation of food adulteration. "FDA's rule produces the absurd result of causing raw, crushed ephedra sinica herb to be unlawful when placed in a gelatin capsule, but legal when placed in a tea bag,"​ it wrote in the appeal.

It calls such risk analysis subjective, and claims that they set a negative precedent for the federal agency's jurisdiction over the entire herbal and supplement industry.

Related news

Show more

Related products

show more

Explore Probiotic Adventure in Weight Management

Explore Probiotic Adventure in Weight Management

Content provided by CJ BIO | 02-Sep-2024 | White Paper

Curious about how you can deliver standout solutions? Dive into our trend report for valuable insights into current weight management market trends and...

The solutions to botanical supply chain challenges

The solutions to botanical supply chain challenges

Content provided by Ayana Bio | 05-Jun-2024 | Infographic

Many botanicals continue to face supply chain challenges, from the surging demand for stress-relieving adaptogens and immune-support ingredients to the...

BIONAP : HARVESTING THE FORCE OF NATURE

BIONAP : HARVESTING THE FORCE OF NATURE

Content provided by BIONAP BIOACTIVE NATURAL PRODUCTS | 30-May-2024 | Product Brochure

Nature's power is a gift, one that BIONAP knows how to use responsibly. From the very beginning of our work to the last detail, Biodiversity is what inspires...

MOROSIL:INGREDIENT OF THE YEAR

MOROSIL:INGREDIENT OF THE YEAR

Content provided by BIONAP BIOACTIVE NATURAL PRODUCTS | 07-Mar-2024 | Product Brochure

MOROSIL™ has won as Ingredient of the Year in the category Weight Management at 2023 Nutraingredient USA. MOROSIL ™ is a standardized extract derived from...

Related suppliers

Follow us

Products

View more

Webinars