Hyland’s Not Affected by FDA Advisory for ZICAM® Intranasal Products

Do Hyland’s homeopathic products with zinc cause anosmia (loss of sense of smell)?

Hyland’s delivers its three cold medicines with zinc orally (Cold Tablets with Zinc, Sniffles ‘n Sneezes 4 Kids, and Cold Relief with Zinc 4 Kids ). There is no association in the medical literature with oral zinc causing anosmia nor are there any confirmed cases of oral zinc medicines causing anosmia. Hyland’s, in fact, has not received any complaints or serious adverse events for any of its cold medicines with zinc.

Hyland’s uses zinc in several of its medications. Are those products going to be recalled as well?

No. Hyland’s products are not affected by the warning issued to Matrixx. Hyland’s does not manufacture products that use an intranasal delivery system (medicines applied directly to the inside of the nose). FDA’s web site specifically notes that its Warning Letter does not affect Zicam’s oral zinc products (medicine taken via the mouth).

How much zinc is in the Hyland’s cold products?

Hyland’s cold products that include zinc gluconate use homeopathically prepared zinc in a dilution of approximately 2X, which means 1 part zinc gluconate to 100 parts diluent.

Are homeopathic medicines regulated by FDA?

Yes, they are regulated by FDA. Under the “Compliance Policy Guide,” FDA sets the standards under which homeopathic medicines can be marketed and also established FDA’s authority to pull homeopathic products off the market if necessary.

How often has a homeopathic drug been recalled?

Homeopathic drugs have been regulated by FDA since 1938. To the best of our knowledge, this is the first time that FDA has had to act against a homeopathic drug on the market because of safety concerns. That is an extraordinary safety record for any class of drugs.