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Thursday, June 13, 2024 | Back issues
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Supplement Makers Lose Fight Against FDA

WASHINGTON (CN) - A federal judge ruled against diet-supplement makers who challenged the FDA's adoption of new manufacturing regulations, which include maintaining and testing equipment, keeping records of complaints and keeping "adequate" and "readily accessible" bathrooms.

U.S. District Judge Beryl Howell found that the regulations "did not exceed the FDA's statutory authority, are not impermissibly vague under the due process clause, and are not arbitrary and capricious under the [Administrative Procedure Act]."

The complaint was filed in 2009 by the Alliance for Natural Health U.S., Duke Pearson and Sandy Shaw and the Coalition to End FDA and FTC Censorship.

Pearson and Shaw said they would lose royalty income from their supplement formulas, as manufacturers would have to cough up more money to comply with the new standards. They said the regulations were arbitrary and capricious, vague and exceeded the FDA's authority.

But Judge Howell rejected the argument that the Food, Drug and Cosmetic Act did not give the FDA authority to regulate dietary supplements, which the Act describes as "a 'product ... intended to supplement the diet' that contains ... 'a vitamin, a mineral, an herb or other botanical, an amino acid, or dietary substance for use by man to supplement the diet by increasing the total dietary intake.'"

He also threw out their claims that recordkeeping and quality control aspects of the regulations overstepped the government's power, agreeing with the FDA that "it has not imposed any standards for which there is no current and generally available analytical methodology."

Howell also dismissed claims that qualifiers such as "adequate" and "suitable" were vague and arbitrary under the APA.

The Alliance of Natural Health says it represents practitioners, medical doctors, scientists, consumers and patients who make, sell, distribute and recommend dietary supplements.

Pearson and Shaw describe themselves they're supplement designers and best-selling authors.

The Coalition to End FDA and FTC Censorship says its purpose is "advocating that federal government agencies not block consumer access to accurate representations concerning the existing science on the role of nutrients in treating and preventing disease."

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