Luden's Echinacea Throat Drops Are Not Dietary Supplements, FDA Says

FDA continues to hold the position that throat or cough drops cannot be classified as dietary supplements, according to a Nov. 4 "courtesy" letter to Hershey Foods recently made available by the agency. Luden's Throat Drops/Herbal Echinacea Supplement with echinacea, rose hips and vitamin C "does not appear to meet the statutory definition of a dietary supplement...and therefore, can not be marketed as a dietary supplement," FDA says (1see box, p. 8). Hershey launched the extension to the Luden's line in August (2see story, p. 6).

FDA continues to hold the position that throat or cough drops cannot be classified as dietary supplements, according to a Nov. 4 "courtesy" letter to Hershey Foods recently made available by the agency. Luden's Throat Drops/Herbal Echinacea Supplement with echinacea, rose hips and vitamin C "does not appear to meet the statutory definition of a dietary supplement...and therefore, can not be marketed as a dietary supplement," FDA says (¹ ). Hershey launched the extension to the Luden's line in August (² (Also see "Luden's Natural Herbal Throat Drops TV Spots Breaking In January" - Pink Sheet, 13 Dec, 1999.)).

"The term 'dietary supplement'...means a product (other than tobacco) intended to supplement the diet that bears or contains a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any of the above ingredients," FDA explains.

"Dietary supplements are intended for ingestion" in tablet, capsule or liquid form, the agency adds. The Luden's Throat Drops product "is not 'intended for ingestion,'" the agency notes, explaining the term "ingestion" means "enteral administration into the stomach and gastrointestinal tract."

"That your product is intended to deliver its contents prior to introduction into the gastrointestinal tract to exert its effect is evidenced by the statement of identity for the product that describes it as 'throat drops,'" FDA tells the company. Hershey introduced Luden's Throat Drops in December 1998.

While courtesy letters are strictly advisory, many firms do make the recommended changes. Nature's Life, for example, relabeled its throat lozenges as a food after receiving a similar "courtesy" letter from FDA for its Zinc Lozenges and Zinkers products (³ (Also see "Nature's Life Relabeling Zinc Lozenges As Food Following "Courtesy" Letter" - Pink Sheet, 8 Mar, 1999.)). FDA also has sent essentially the same letter to Herbalife for its Zinc & Echinacea Throat Lozenges (⁴ (Also see "Herbalife Zinc Throat Lozenges Are Not Dietary Supplements, FDA Says" - Pink Sheet, 14 Dec, 1998.)).

FDA also recently told American Specialty Health & Wellness its Melatonin Lozenges do not meet the definition of "dietary supplement" for the same reason. The Oct. 1 courtesy letter cites the firm's statement the "product is a sublingual lozenge (to be placed under the tongue) for rapid absorption" as evidence it is intended to deliver its contents prior to introduction into the GI tract.

The letter also takes issue with the company's use of the structure/function claim "During times of stress and infection, the body's need for B-vitamins increases" for Vitamin B-Complex, stating it is a drug claim suggesting the product is intended for use to treat or prevent infections. In addition, the letter notes the firm's claim for Folic Acid to "prevent neural tube birth defects in their babies" is a health claim and not a structure/function claim.

San Diego-based American Specialty Health & Wellness received a previous courtesy letter from FDA in October 1998 for structure/function claims submitted for a number of its products including Zinc Chewable, Yin Essentials, Yang Essentials and Women's Harmony. The firm also has been cited in a courtesy letter for making cholesterol reduction claims for several products.

FDA also continues to send out courtesy letters in response to cholesterol reduction claims. A Nov. 8 letter to Atkins Nutritionals cites the claim "Provides natural dietary support for the lowering of elevated cholesterol." The agency's Oct. 29 notice to Nordic Naturals cites the claim "Lowered LDL cholesterol," and Sept. 24 and 28 letters to E'Ola International list similar claims for two of the company's products. All are drug claims implying the products treat or prevent hypercholesterolemia, FDA says.

In addition, Nutritional Specialties was told by the agency its LifeTime Choles-Control Standardized Red Rice Yeast Extract cannot be legally sold in the U.S. as FDA awaits a ruling on its appeal of a federal court decision to set aside the agency's ban of the product.

"At this time, FDA believes that products containing red yeast rice or Monascus purpureus that contain lovastatin are unapproved new drugs that are in violation of the FD&C Act," the Nov. 10 courtesy letter states.

Other types of claims targeted by FDA in recent advisory letters include "Relief of seasonal allergies," "Lowering of elevated blood pressure," "Relief of mild depression," "Address the issues of PMS, post- and peri-menopause and bone density loss" and "Aids in combating obesity." One letter, to Fremont, Calif.-based Maxi-Health Herb Products, says the claim "Alleviate the negative side effects associated with chemotherapy and/or radiotherapy" is a drug claim in that "the product is represented as an adjunct to mitigate the side effects of recognized disease therapies."