Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
Central Region
Cincinnati District Office

 

6751 Steger Dr
Cincinnati, OH 46237-30977
Telephone: 513-679-2700
FAX: 513-679-2761

June 8, 1999
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

William S. Gandee, President
Natural Revelations, Inc.
2050 S. Arlington Rd
Akron, OH 44306

Ref. No. CIN-WL-99-209

Dear Mr Gandee:

This letter is in reference to your firm's marketing and distribution of the product "Nature's Gel". The label for this product states that it contains menthol, eucalyptus oil, and capsicum as the active ingredients.

Labeling claims in the brochure titled "NATURE'S GEL" include:

The Nature's Gel label states that it is for "*Arthritis *Bursitis *Simple Backache *Muscle Aches *Rheumatism *Sprains *Strains *Sport Injuries *For Prevention Use Prior To Exercise."

Based on its intended uses cited above, Nature's Gel is an external analgesic drug (section 201(g) of the Federal Food, Drug and Cosmetic Act [the Act]). Even though there is no final monograph (FM) for this class of OTC drug products, the agency on November 7, 1990 published a Final Rule establishing that certain ingredients in OTC drug products are not generally recognized as safe and effective and are misbranded. This Final Rule states that after May 7, 1991, any OTC drug product with eucalyptus oil which is intended for use as an external analgesic is subject to regulatory action if marketed in the United States (21 CFR 310.545(10(ii)) as a new drug (section 210(p) of the Act) and may not be legally marketed in the United States since it is not approved (section 505 of the Act). Additionally, this drug remains an unapproved new drug if reformulated without Eucalyptus based on its claims. This drug is misbranded (section 502(f)(1)), because it's labeling fails to bear adequate directions for use.

The Nature's Gel label does not indicate that Natural Revelations, Inc. is only the distributor and not the manufacturer. This causes the product to be misbranded under Section 502(b) of the Act.

This letter is not intended to be an all-inclusive review of all labeling and products that your firm markets. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and its implementing regulations. (This includes all labeling and promotional materials).

We request that you take prompt action to correct these violations. Failure to promptly correct violation may result in enforcement action being initiated by the Food and Drug Administration without further notice. The Federal Food, Drug and Cosmetic Act provides for the seizure of illegal products and for injunction against the manufacturer and/or distributor of illegal products.

Please notify this office in writing within fifteen (15) working days of receipt of this letter as to the specific steps you have taken to correct the stated violations. You should also include an explanation of each step being taken to identify and make corrections to assure that similar violations will not recur. If corrective action cannot be completed within 15 working days, please state the reason for the delay and the time within which the corrections will be completed.

Your reply should be sent to Lawrence E. Boyd, Compliance Officer, Food and Drug Administration, 6751 Steger Dr, Cincinnati, OH 45237-3097.

Sincerely,
/s/
Henry L. Fielden
District Director

This page was posted on August 20, 2006.

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