pad

Antioxidants in Cancer Therapy-Review of Literature

U. S. Department of Health and Human Services U. S. Food and Drug Administration Center for Food Safety and Applied Nutrition Office of Nutritional Products, Labeling and Dietary Supplements

April 1, 2003

Letter Regarding Dietary Supplement Health Claim for Antioxidant Vitamins and Risk of Certain Cancers

Jonathan W. Emord Emord and Associates, P.C. Suite 600 1050 17th Street, N.W. Washington, D.C. 20036

Dear Mr. Emord:

This letter is a follow-up to the Food and Drug Administration's February 11, 2003, letter, pursuant to the opinion and order issued December 26, 2002, by the U.S. District for the District of Columbia in Whitaker, et al. v. Thompson, et al., Civil No. 01-1539, and your response dated February 13, 2003.

As you know, the United States withdrew its notice of appeal in this matter on March 28. The purpose of this letter is to formalize the contingent understanding we reached in mid-February.

In its opinion and order, the Court instructed FDA to draft one or more "short, succinct, and accurate disclaimers" for the health claim: "Consumption of antioxidant vitamins may reduce the risk of certain kinds of cancer." Slip Op. at 37; see Order at 1-2.

As we explained in our February 11 letter, FDA considered the two disclaimers suggested by the Court, as well as a number of others, and concluded the following three alternative disclaimers best meet the criteria specified in the Court's decision:

Some scientific evidence suggests that consumption of antioxidant vitamins may reduce the risk of certain forms of cancer.

However, FDA has determined that this evidence is limited and not conclusive.

Some scientific evidence suggests that consumption of antioxidant vitamins may reduce the risk of certain forms of cancer.

However, FDA does not endorse this claim because this evidence is limited and not conclusive.

FDA has determined that although some scientific evidence suggests that consumption of antioxidant vitamins may reduce the risk of certain forms of cancer, this evidence is limited and not conclusive.

Your February 13 letter indicated that your clients accept these disclaimers, and that the various petitioners in this matter wish to have the option of using any of three disclaimers on their products with the antioxidant vitamin claim.

FDA intends to exercise its enforcement discretion with respect to antioxidant vitamin dietary supplements containing vitamin E and/or vitamin C when:

(1) one of the above disclaimers is placed immediately adjacent to and directly beneath the antioxidant vitamin claim, with no intervening material, in the same size, typeface, and contrast as the claim itself;

(2) the supplement does not recommend or suggest in its labeling, or under ordinary conditions of use, a daily intake exceeding the Tolerable Upper Intake Level established by the Institute of Medicine (IOM) of 2000 mg per day for vitamin C and 1000 mg per day for vitamin E (see May 4, 2001, letter at 4-6 and references cited therein).

Antioxidant vitamin supplements bearing the claim and one of the disclaimers are still required to meet all applicable statutory and regulatory requirements under the Federal Food, Drug, and Cosmetic Act, including the applicable requirements for health claims.

Sincerely,

Christine L. Taylor, Ph.D. Director Office of Nutritional Products, Labeling and Dietary Supplements Center for Food Safety and Applied Nutrition

- - - - - - - - - - - - - - - - - - - - - - - - - - - - -



Antioxidants in Cancer Therapy; Their Actions and Interactions With Oncologic Therapies

Davis W. Lamson, MS, ND and Matthew S. Brignall, ND

Abstract

There is a concern that antioxidants might reduce oxidizing free radicals created by radiotherapy and some forms of chemotherapy, and thereby decrease the effectiveness of the therapy. The question has arisen whether concurrent administration of oral antioxidants is contraindicated during cancer therapeutics.

Evidence reviewed here demonstrates exogenous antioxidants alone produce beneficial effects in various cancers, and except for a few specific cases, animal and human studies demonstrate no reduction of efficacy of chemotherapy or radiation when given with antioxidants. In fact, considerable data exists showing increased effectiveness of many cancer therapeutic agents, as well as a decrease in adverse effects, when given concurrently with antioxidants.

Alternative Medicine Reviews, 1999;4(5):304-329


pad
padIntroduction and Conflicting Views
pad
Antioxidant Use in Cancer Therapy
pad
References
Vitamin A (Retinoids) and Carotenoids
Vitamin C
Overview of Cancer Therapeutic Agents
Vitamin E
Melatonin
Selenium
Co Q10
NAC and Glutathione
Flavonoids
Combining Antioxidants
Current Attitudes & New Approaches
Conclusions - Antioxidants in Cancer Therapy
pad
padAntioxidant Supplementation on Chemotherapeutic Efficacy:systematic review
pad
Cancer Treatment Reviews, 8/07
pad
pad
pad
padAntioxidant Supplementations in Men Reduces Incidence CA
pad
JAMA,11/04 Archives of Internal Medicine
pad
pad
padReferences
pad
180 studies examined
pad
pad
pad
padUse of Antioxidants & Cytotoxic Treatments
pad
Ralph Moss Talk, July, 2001
pad
Cancer (Adjuvant) Therapy
Mega-Dose Vitamins/Minerals in Treatment
Chemo & Supplements:Adriamycin/Vit E/Fish Oil
Antioxidants enhance cytotoxicity of chemotherapy:Colorectal Ca
pad
padDietary Antioxidants & Chemotherapy
pad
Nutrition and Cancer 37(1):1-18, 2000
pad
Dietary Antioxidants- Conclusions from an Overview
Dietary Antioxidants in Swedish Women
Serum Cartotenoids/Breast Cancer
Chemotherapy w Antioxidants
Vitamin supplementation Reduced Toxicity Pemetrexed/Vit Bs
pad
pad
padAntioxidants Resolve Rtx Adverse Effects
pad
Am J Gastroenterol, 2001
pad
pad
padReview of Italian Studies on Veg/Fruit/Antioxidants
pad
Eur J of Nutritoin, 2001
pad
pad
pad
padMultiple Antioxidants Improve Efficacy
pad
Paper was published and presented at NOAT, 2000 (See Meeting Summaries)
pad
pad
padSystemic Screening of Total Antioxidants in Dietary Plants
pad
J. Nutr. 132:461-471, 2002
pad
pad
pad
padHigh Oxidation/Low Antioxidant Levels...
pad
Cancer, 6/02 Plus direct communication with the author
pad
pad
padHerbs, Vitamins & Antioxidants w/Cancer Treatments:TCM
pad
Subhuti Dharmananda, Ph.D., Director, Institute for Traditional Medicine
pad
pad
pad
padGarlic (Allium sativum) & Pharmacokinetics of Docetaxel
pad
Clin Cancer Res, 8/06
pad
pad
padArticle References
pad
Alternative Medicine Reviews, 1999;4(5):304-329.
pad
pad
pad
padMolec targets of dietary agents 4 prvntn & thrpy of cancer.
pad
Biochem Pharmacol, 5/06
pad
pad
padHigh Doses of Antioxidants Do NOT decrease efficacy of Chemo
pad
Letter by Dr. Abram Hoffer (part I)
pad
pad

Remember we are NOT Doctors and have NO medical training.

This site is like an Encylopedia - there are many pages, many links on many topics.

Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.