Enforcement on Standard Homeopathic Co.'s Hyland's Teething Tablets marks FDA's second action in 18 months against a major U.S. homeopathic firm.

Standard, one of the largest U.S. homeopathic businesses, voluntarily recalled all lots of the Hyland's product and began overhauling its manufacturing when FDA issued a consumer alert after officials found inconsistent amounts of belladonna in the tablets.

Standard says it is working with the agency and expects to return the teething product to the market in 2011.

Mary Borneman, Standard's communications manager, said Oct. 28 the Los Angeles firm initiated the recall as a "precautionary measure" because no adverse events are "conclusively linked to this product."

FDA, however, said it "has received reports of serious adverse events in children taking this product that are consistent with belladonna toxicity." Because the substance can cause serious harm at larger doses, the amount of belladonna in products must "be carefully controlled," FDA said Oct. 23.

According to information Standard posted on its website before the recall, a 10-pound child would need to ingest 1,000 Hyland's Teething Tablets "to exhibit even the first possible side effect of belladonna."

In July 2009, following Matrixx Initiatives' voluntary recall of zinc-containing Zicam intranasal gels, Standard CEO J.P. Borneman observed that homeopathic products have a strong track record of adhering to FDA compliance policy (Also see "Safety, Convenience Propel Homeopathic Firms' Push For Market Share" - Pink Sheet, 20 July, 2009.).

Borneman also said he was aware of questions about the safety of the Zicam intranasal gel delivery system – direct application to the interior of the nose. Further, he pointed out that although Zicam is a homeopathic drug, Matrixx's marketing was "not closely associated" with homeopathy.

Matrixx has not returned its recalled products to the market due to FDA's concerns about the intranasal application of zinc (Also see "Zicam Lawsuits Multiply, But Matrixx Is Confident History Will Repeat Itself" - Pink Sheet, 29 June, 2009.).

Standard’s problems may be easier to surmount than Matrixx's.

Belladonna can cause serious harm at larger doses and the amount in products must "be carefully controlled." – FDA

Manufacturing Controls Faulted

FDA's release stated that an inspection at Standard indicated "substandard control of the manufacturing operation." The firm agreed to conduct the recall after consultation with FDA officials.

FDA also noted that like other homeopathics, it has not evaluated Hyland's Teething Tablets for safety or efficacy and is not aware of any proven clinical benefit offered by the product. The agency's Center for Drug Evaluation and Research said its investigation of the firm and its manufacturing is ongoing.

Further, the agency said it has received reports of children consuming more tablets than recommended because the containers do not have child-resistant caps.

CDER staff explained that while FDA does not impose "a regulation broadly requiring homeopathic OTC drug products to have child-resistant packaging," the U.S. Consumer Product Safety Commission can require child-resistant packaging of hazardous household chemicals, including drug products.

Borneman said Standard initiated a project prior to the recall to add a child-resistant cap to Hyland's Teething Tablets. The feature will be included when the product returns to the market, she said in an e-mail.

She added Standard will consult with FDA on the manufacturing overhaul before resuming shipment of the product. "The company has the intention of meeting all the requirements" FDA sets for its products, Borneman said.

Standard Touts Homeopathic Safety

According to a Sept. 24, 2010, post on Standard Homeopathic's website noting the safety of Hyland's Teething Tablets, Hyland's homeopathic medicines are manufactured "within a validated process, as with any FDA-regulated drug, to ensure an accepted level of consistency in product output."

The firm states its teething and other products are prepared in accordance with the Homeopathic Pharmacopoeia of the U.S., which "has been recognized by the FDA since 1938 as the official compendium (or formula book) for homeopathic medicine in the U.S." Active ingredients in homeopathic products "are diluted to the point that the risk of toxicity is extremely low," according to the release.

Standard says it includes "approximately 0.0002 mg" of belladonna alkaloids in its teething product to ease the redness, inflammation and discomfort of a child's gum. The product also contains calcarea phosphorica to support teeth formation, chamomilla for its actions on irritability commonly associated with teething pain and coffea cruda for its actions on wakefulness and increased urination.

The firm's website also includes a December 2009 release on Hyland's Calms Forté sleep-aid receiving a Better Nutrition’s 2009 Best of Supplements Award, chosen in a survey of health food storeowners and consumers and from natural product sales data. The product contains active botanicals passiflora, avena sativa, humulus lupulus and chamomilla, according to Standard.

By Malcolm Spicer

Inspection, AERs Prompt Hyland's Teething Tablets Recall

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