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

Public Health Service
Food and Drug Administration


Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 98021-4421
Telephone: 425-486-8788
FAX: 425-483-4996

June 25, 2004


In reply refer to Warning Letter SEA 04-39

Ryan R. DeLuca, President
Higher Power, Inc.
361 Steelhead Way
Boise, Idaho 83704


Dear Mr. DeLuca:

This letter is in reference to your firm’s marketing and distribution of ASN Canthaxanthin capsules and Universal Canthaxanthin tablets. The Food and Drug Administration (FDA) has reviewed your web site at the following address: This review shows serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) in the labeling of these products. You can find the Act and implementing regulations through links on FDA’s Internet home page at

Under the Act, articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man are drugs [Section 201(g)(1)(B) of the Act]. Furthermore, articles other than food that are intended to affect the structure or any function of the body of man are drugs [Section 201(g)(1)(C) of the Act]. Your web site claims that your products ASN Canthaxanthin capsules and Universal Canthaxanthin tablets are useful in the prevention of sun damage, genetic damage, and skin cancer. The Internet labeling of your products bears the following claims:

These claims cause your products to be drugs as defined in sections 201(g)(1)(B) and 201 (g)(1)(C) of the Act. Because these products are not generally recognized as safe and effective when used as labeled, they are also new drugs as defined in section 201(p) of the Act. Under section 505 of the Act, a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA).

Even if the labeling for these products did not contain claims which cause them to be drugs, these products are adulterated cosmetics. Your Internet web site promotes these products for coloring the skin. The Act defines the term “cosmetic” at section 201 (i)(1) to include articles intended to be introduced into the human body for altering appearance. The following web site statements establish that these canthaxanthin products are intended for use to alter the skin color to simulate a suntan:

The above claims establish that the canthaxanthin products you are currently marketing on your web site are intended to impart color to the skin, thus making them cosmetic products.

The Act defines the term “color additive” at section 201 (t)(1)(B) as a material which, when added or applied to a food, drug, or cosmetic, or to the human body or any part thereof, is capable (alone or through reaction with another substance) of imparting color thereto. Canthaxanthin is a color additive. Color additives are deemed to be unsafe unless they are used in accordance with a color additive regulation that specifies the conditions under which the color additive may be safely used, including the purposes for which it may be used and the product category or categories to which it may be added [Section 721 (a) of the Act]. There is no color additive regulation currently allowing for the use of canthaxanthin to impart color to the skin or, for that matter, for the use of canthaxanthin in a cosmetic product for any purpose.

Based on the above, the canthaxanthin products you are marketing on your web site are adulterated under section 601(e) of the Act, in that they bear or contain a color additive, namely canthaxanthin, which is unsafe within the meaning of section 721(a) of the Act. It is a violation of section 301(a) of the Act to introduce or deliver for introduction into interstate commerce any cosmetic that is adulterated.

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

We request that you take prompt action to correct these violations. Failure to promptly correct these violations may result in enforcement action being initiated by the Food and Drug Administration without further notice. The 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 the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify and make corrections to assure that similar violations will not recur. If the corrective action cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be implemented.

Your reply should be sent to the Food and Drug Administration, Attention: Lisa Althar, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have any questions regarding this letter, Ms. Althar can be reached at (425) 483-4940.



Charles M. Breen
District Director

This page was posted on November 25, 2004.

Links to Recommended Companies

  • Compare drug prices and save money at verified online pharmacies.
  • Evaluates the quality of dietary supplement and herbal products.
  • Discount prices, huge inventory, and superb customer service.
  • OnlyMyEmail: Award-winning anti-spam services.
  • 10 Types: Website design, development, and hosting with superb technical support.