BIO Mary Nash Stoddard on Twitter

PRESENTING: MARY NASH STODDARD - Co-Founder of the massive international anti-aspartame movement in the mid 1980's, following the brain tumor death of her forty two year old husband, Mike. Ms. Stoddard suffered a life threatening aspartame-related blood disorder in 1985, whereupon, The NutraSweet Co. offered her an all-expense paid vacation for two anywhere in the world, if she would agree to be tested by their doctors. She declined, with the blessing of her doctor, and the rest is history. She has conducted multi-national lecture tours and is a popular visiting professor at colleges, universities and medical schools. "Deadly Deception - Story of Aspartame" is a toxicology sourcebook, edited by Ms. Stoddard, documenting the harmful effects of the world's most toxic artificial sweetener. The companion one hour "Deadly Deception" video is further documentation - taped at a prestigious scientific conference. Stoddard's efforts, over more than two decades, led to the present rejection of the sweetener by many of the food and beverage giants of industry, as they rush to distance themselves from the liabilities associated with use of a neuro-toxic substance in their products. She has testified in court as an Expert Medical Witness and like her counterpart, Erin Brokovitch, helped with a number of lawsuits on behalf of consumers. Her powerful message has reached millions around the world through the airwaves on radio and television, in print and through popular personal appearances. Honors, Awards, Societies: • Expert Medical Witness [1992-present] * Guest Presenter Gulf War Veterans Annual Conference - [Las Vegas 1999] * Visiting Professor: U. T. Southwestern Medical School [1997] * Visiting Professor: American University School of Journalism [1999] * Visiting Professor: University of North Texas at Denton Dept. of Science [1990 and 2005] • Visiting Professor: University of Houston Bioneers Conference [2006] * Invited speaker: Hebrew Univ. Jerusalem - [1997] * Keynote speech: Mexican Government's Annual Conference on Sweeteners [1999] * Appointed Judge - State of Texas [1977-1984] * Broadcast Journalist - [1965-present] * President's Council on Food Safety - [1998-1999] * International Lecture Tours - [1996-present] * Testimony Senate Committee Hearing on Safety of Aspartame - Washington [1987] * Panelist at National News Conference Announcing Dr. John Olney's Brain Tumor/Aspartame Connection - Washington D.C. [1998] * Inducted Member Texas Radio Hall of Fame [2002-present] Representative of the Texas Rice Growers Association [Miss Rice] Board member: Irving Symphony Orchestra Board Member: Irving Community Theater Founding Board Member Radio Station KNON [public radio], Dallas Charter member City of Dallas Citizens Safety Committee Board Member Dallas Mayor’s Fee Task Force Vice President Operation Get Involved, [liaison committee of the D.P.D.] Board member Dallas Homeowners League President Save Open Space Texas Steering Committee Presidential Election Award for Public Service - Mexican Government State of Texas Board of Adjustment

Thursday, April 28, 2016


Sent: Sunday, January 12, 2003 11:12 PM To: Subject: Docket # 02P-0317 Recall Aspartame as a Neurotoxic Drug: File #4: Reported Aspartame Toxicity Reactions  Subject: Docket # 02P-0317  To: FDA Dockets Submittal

Q.  What are the reported reactions to aspartame ingestion? How often are such effects seen? 

Answer We will limit our discussion in this FAQ to reported toxicity reactions to aspartame ingestion.  Controlled studies showing problems with aspartame ingestion will be discussed in another FAQ. 

Toxicity reactions to aspartame can be divided into three types:  1.  Acute toxicity reactions occuring within 48 hours of ingestion of     an aspartame-containing product.  2.  Chronic toxicity effects occuring anywhere from several days of     use to appearing a number of years (i.e., 1-20+ years) after the     beginning of aspartame use.  3.  Potential toxicity effects that would be nearly impossible for     the user to recognize the link to aspartame.  In an epidemiological survey which appeared in the Journal of Applied Nutrition (Roberts 1988), 551 persons who have reported toxicity effects from aspartame ingestion were surveyed.  The adverse effects found cover a subset of reported acute and chronic toxicity effects from aspartame. What follows is a listing of the adverse health effects which were found.
# of                                              people  (%) Eye - Decreased vision and/or other eye problems     140   (25%)     (blurring, "bright flashes," tunnel vision) - Pain (one or both eyes)                          51    (9%) - Decreased tears, trouble with contact lens,     46    (8%)     or both - Blindness (one or both eyes)                    14    (3%)  Ear - Tinnitus ("ringing," "buzzing")                 73   (13%) - Severe intolerance for noise                    47    (9%) - Marked impairment of hearing                    25    (5%)  Neurologic - Headaches                                      249   (45%) - Dizziness, unsteadiness, or both               217   (39%) - Confusion, memory loss, or both                157   (29%) - Severe drowsiness and sleepiness                93   (17%) - Paresthesias ("pins and needles," "tingling")   82   (15%)     or numbness of the limbs - Convulsions (grand mal epileptic attacks)       80   (15%) - Petit mal attacks and "absences"                18    (3%) - Severe slurring of speech                       64   (12%) - Severe tremors                                  51    (9%) - Severe "hyperactivity" and "restless legs"      43    (8%) - Atypical facial pain                            38    (7%)  Psychologic-Psychiatric - Severe depression                              139   (25%) - "Extreme irritability"                         125   (23%) - "Severe anixiety attacks"                      105   (19%) - "Marked personality changes"                    88   (16%) - Recent "severe insomnia"                        76   (14%) - "Severe aggravation of phobias"                 41    (7%)  Chest - Palpitations, tachycardia (rapid heart action), 88   (16%)     of both - "Shortness of breath"                           54   (10%) - Atypical chest pain                             44    (8%) - Recent hypertension (high blood pressure)       34    (6%)  Gastrointestinal - Nausea                                          79   (14%) - Diarrhea                                        70   (13%)     Associated gross blood in the stools (12) - Abdominal pain                                  70   (13%) - Pain on swallowing                              28    (5%)  Skin and Allergies - Severe itching without a rash                   44    (8%) - Severe lip and mouth reactions                  29    (5%) - Urticaria (hives)                               25    (5%) - Other eruptions                                 48    (9%) - Aggravation of respiratory allergies            10    (2%)  Endocrine and Metabolic - Problems with diabetes:  loss of control;       60   (11%)     precipitation of clinical diabetes;     aggravation or simulation of diabetic     complications - Menstrual changes                               45    (6%)     Severe reduction or cessation of periods (22) - Paradoxic weight gain                           34    (5%) - Marked weight loss                              26    (6%) - Marked thinning or loss of the hair             32    (6%) - Aggravated hypoglycemia (low blood sugar        25    (5%)     attacks)  Other - Frequency of voiding (day and night), burning   69   (13%)     on urination (dysuria), or both - Excessive thirst                                65   (12%) - Severe joint pains                              58   (11%) - "Bloat"                                         57   (10%) - Fluid retention and leg swelling                20    (4%) - Increased susceptibility to infection            7    (1%)  -------------------  There are other clinical reports in the scientific literature of aspartame-caused toxicity reactions including Blumenthal (1997), Drake (1986), Johns (1986), Lipton (1989), McCauliffe (1991), Novick (1985), Watts (1991), Walton (1986, 1988), and Wurtman (1985). 

Many pilots appear to be particularly susceptible to the effects of aspartame ingestion.  They have reported numerous serious toxicity effects including grand mal seizures in the cockpit (Stoddard 1995). Nearly 1,000 cases of pilot reactions have been reported to the Aspartame Consumer Safety Network Pilot Hotline (Stoddard 1995). This susceptibility may be related to ingesting methanol at altitude as suggested in a letter from Dr. Phil Moskal, Professor of Microbiology, Biochemistry, and Pathology, Chairman of the Department of Pathology, Director of Public Health Laboratories (Moskal 1990), or it may simply be that some pilots tend to ingest large quantities of aspartame during a flight.  Whatever the case, numerous warnings about aspartame dangers have appeared in piloting journals including:

The Aviation Consumer (1988),
Aviation Medical Bulletin (1988),
Pacific Flyer (1988),
CAA General Aviation (1989),
Aviation Safety Digest (1989),
General Aviation News (1989),
Plane & Pilot (1990),
Canadian General Aviation News (1990),
National Business Aircraft Association Digest (NBAA Digest 1993),
International Council of Air Shows (ICAS 1995), and Pacific Flyer (1995). 
Both the U.S. Air Force's magazine "Flying Safety" and the U.S. Navy's magazine, "Navy Physiology" published articles warning about the many dangers of aspartame including the cumulative deleterious effects of methanol and the greater likelihood of birth defects.

The articles note that the ingestion of aspartame may make pilots more susceptible to seizures and vertigo (US Air Force 1992).  Countless other toxicity effects have been reported to the FDA (DHHS 1995), other independent organizations (Stoddard 1995), and independent scientists (e.g., 80 cases of seizures were reported to Dr. Richard Wurtman, Food (1986)).

Frequently, aspartame toxicity is misdiagnosed as a specific disease. This has yet to be reported in the scientific literature, yet it has been reported countless times to independent organizations and scientists (Stoddard 1995).  In other cases, it has been reported that chronic aspartame ingestion has triggered or worsened certain chronic illnesses.  Nearly 100% of the time, the patient and physician assume that these worsening conditions are simply a normal progression of the illness.  Sometimes that may be the case, but many times it is chronic aspartame poisoning.  According to researchers and physicians studying the adverse effects of aspartame, the following list contains a selection of chronic illnesses which may be caused or worsened by the chronic, long-term ingestion of aspartame. (Stoddard 1995)*:      
Brain tumors              
Multiple sclerosis     
Chronic fatigue syndrome     
Parkinson's Disease       
Mental retardation        
Birth defects             
Arthritis (including Rheumatoid)     
Chemical Sensitivities    
Attention Deficit Disorder      
*Note: In some cases such as MS, the severe symptoms mimic or exacerbate the illness,             but do not cause the disease. 
Also, please note that this is an incomplete list.  Clearly, ingestion of a very slow poison (as discussed in other FAQs) is not beneficial to anyone who has a chronic illness. 

Finally, potential toxicity effects from aspartame including brain cancer (as seen in pre-approval research) and effects on fetal brain and nervous system development will be discussed in other FAQs. 
How often are such effects seen? 
Until recently approximately 90% of aspartame sales were in the United States (Monsanto 1994).  Other countries are now being inundated with aspartame, but it will be some time until they begin to feel the full effects of aspartame toxicity on the general population. 

Since the U.S. has some history of significant use, we will limit the discussion to the frequency of effects in the U.S.  There have been well over 7,000 aspartame toxicity reactions officially received by the U.S. Food and Drug Administration between 1982 (after aspartame was first approved) until 1995 (DHHS 1993, DHHS 1995). From this figure, we can estimate the number of actual toxicity reactions observed. 

FDA officials believe that as little as 1% of the serious adverse drug reactions are reported to the FDA (Kessler 1993).  Using a reported rate of 1%, we would estimate that there have been 700,000 recognized aspartame toxicity reactions in the U.S. since 1982.  However, there are a number of significant adjustments that must be made before we can accept this estimate. 

1.   Most physicians are aware of the Adverse Reaction Monitoring System (ARMS) and are encouraged by the FDA to report serious adverse drug reactions (Kessler 1993).    
2.   Physicians are not encouraged by the FDA to report aspartame toxicity reactions to the FDA (Food 1995).  The lay public is generally unaware of ARMS and much less likely to     report adverse reactions to the FDA.  Therefore, this would lower the estimated reporting rate below 1%.  Let us make a     small adjustment and estimate a 0.88% reporting rate.
3.    It was pointed out by James Turner, Esq. in a letter to the then FDA Commissioner, Frank Young, that no program to monitor aspartame     toxicity reactions was created until February 1984, two years after aspartame approval began (Turner 1984).  This would probably add at least 1,200 reported reactions (probably much more), so that we should use 8,200 toxicity reaction reports. 

In addition, a Freedom of Information act request determined that the regional FDA offices had been told that only "serious" complaints should be forwarded to the FDA headquarters (Turner 1984). 
"Serious" complaints were complaints where the illness was severe enough to require the attention of a physician.  Since this happened between 1984 (when the monitoring system began) and 1985, we can estimate an additional 300 toxicity reactions would have been reported for a total of 8,500. 

3.  In 1987, it was brought out at U.S. Congressional Hearings that the FDA had been transferring aspartame toxicity reaction calls     to the AIDS Hotline (Stoddard 1987).  In addition, it was reported     by James Turner, Esq. of Community Nutrition Institute (CNI) and Mary Nash Stoddard of Aspartame Victims and Their Friends, that there were numerous cases of people calling the FDA to report     toxicity reaction and they were told that there was no connection     between aspartame and adverse reactions and no other information was taken by the FDA.  While this may not effect the reporting rate     after the start of 1988, it would significantly affect the reporting rate before that time.  Let us make another small adjustment and estimate a 0.78% reporting rate. 

4.   Perhaps the biggest reduction in the reporting rate comes from the fact that Commissioner Kessler's estimated 1% reporting rate for adverse drug reactions involves only "serious" adverse reactions.  The rate for reporting *all* drug reactions (if such     reporting was done) would almost certainly be no more than 0.5%. Therefore, if we cut our current estimated reporting rate of 0.78% in half, the estimated reporting rate for *all* toxicity reactions to aspartame (including serious or mild) would be no more than 0.39%. 

5.   During the first couple of years that aspartame was on the market, there was publicity that would likely have increased the reporting rate.  However, since the FDA did not have a monitoring system in place until February 1984, the estimated increased number of reports will not be that much.  I will reduce the number of reports by 1,000 to 7,500 to take this into account.

6.   We now have approximately 7,500 reports at an estimated reporting rate of 0.39%.  This totals approximately 1.9 million *recognized* aspartame toxicity reactions in the U.S. between 1982 and 1995.

7.   These reactions run anywhere from mild to very serious illnesses. It is very important to understand, however, that 1.9 million represents only those toxicity reactions that have been discovered by users and/or healthcare practitioners.  Quite often, I encounter case histories were people suffered for a long time and did not make the connection.  For example: "I have suffered from Migraines for years. As soon as I gave up     Nutrasweet my migraines disappeared. All those Cat Scans, MRI's for nothing."     "Since I last wrote my brother has been off nutrasweet since then.  My brothers' lupus symptoms completely went away. My brother has been a physician for over 10 years. His doctor (a specialist) who has been treating him has seen the significant difference and wants to write a research paper on this .. my brothers physician has now started     prescribing getting off nutrasweet for his other patients."  Therefore, I believe that in addition to the estimated 1.9 million people in the U.S. who have recognized aspartame toxicity reactions in themselves (from serious to mild), there are many times that number who are suffering from some of the symptoms mentioned above and that they do not recognize that chronic aspartame use is the cause or at least a contributory factor.  I would estimate that *at least* 7.6 million others are suffering from some symptoms related to aspartame use (many mild symptoms, but many serious ones as well) and do not recognize the connection.  In addition to the estimated 1.9 million recognized reactions and 7.6 million unrecognized reactions in the U.S., it is very important to note that aspartame has been used in significant amounts in the U.S. for a relatively short time.  A U.S. Department of Agriculture report noted that it wasn't until approximately 1987 that aspartame was used in significant amounts in the U.S. (USDA 1988).  Therefore, aspartame had been used for only nine (9) years in signficant amounts through 1995.  When one considers that the damage from aspartame is often silent and cumulative (much like chain-smoking cigarettes), one can see that a couple of generations of aspartame use might be disasterous!  The FDA and NutraSweet have claimed that the number of reported adverse reactions have declined substantially since the mid- 1980s (Pauli 1995, Butchko 1994).  In addition, the FDA recently claimed that the number of reported toxicity reactions for 1995 was only 11 (WSJ 1996)! 

8.   It is important to realize that during the mid-1970s the FDA was investigating wrong-doings of the aspartame manufacturer and stated the facts exactly as they found them:       "[The manufacturer] lied and they didn't submit the real nature of their observations because had they done that it is more than likely that a great number of these studies would have been rejected simply for adequacy. What Searle did, they took great pains to camouflage these shortcomings of the       study.

9.   As I say filter and just present to the       FDA what they wished the FDA to know and they did other terrible things.

10. For instance animals would develop tumors while they were under study. Well they would remove these tumors from the animals."       [FDA Toxicologist and Task Force member, Dr. Andrian Gross (Wilson 1985)] 

11. During the late 1970s and early 1980s, a number of key government and FDA officials left their jobs to work with companies related to the aspartame industry (GAO 1986).  This included key FDA officials such as the head of the FDA Bureau of Foods becoming a Vice President of the National Drink Association and the FDA Commissioner becoming a high-paid consultant for the manufacturer's PR firm, Burson Marsteller (Gordon 1987). 

After this period of time, there was no scientific evidence and no amount of serious toxicity reports that could get the FDA to seriously consider funding independent, properly-conducted (e.g., chronic exposure) research.  That appearance of the FDA being under the total control of the manufacturer, Monsanto, continues to this day.  I include these comments about the FDA to demonstrate why no independent scientist familiar with the aspartame issue takes statements from the FDA such as "11 reported reactions in 1995" seriously.  There are many people, including myself who have received that many toxicity reaction reports in a single day during 1995.

The reality is that independent organizations have noted that aspartame toxicity reaction reports given to them have *increased* every year since the late 1980s (Stoddard 1995).  It is also important to note that in mid-1995, the FDA admited that it had stopped recording aspartame toxicity reactions (Food 1995). 

That may have something to do with why the numbers that the FDA reported to the Wall Street Journal (WSJ 1996) were so small!                        References Cited 
Aviation Consumer 1988. "SafeGuard," June 15, 1988.  Aviation Medical Bulletin 1988. "Pilots and Aspartame,"October 1988. 
Aviation Safety Digest 1989. "Aspartame -- not for the   dieting pilot?"
Aviation Safety Digest, ASD 142, Spring   1989 (Australia - 062/5841111).  Blumenthal, H.J., D.A. Vance, 1997, "Chewing Gum Headaches,"   Headache, Volume 37, Number 10, pages 665-666.  Butchko, Harriett H., Frank N. Kotsonis 1994. "Postmarketing   Surveillance in the Food Industry: The Aspartame Case   Study," in Nutritional Toxicology, edited by Frank N.   Kotsonis, Maureen Macky and Jerry Hjelle, Raven Press,Ltd., New York, c1994. 
CAA General Aviation (1989). Safety Information Leaflet,   April 1989, Great Britain. 
Canadian General Aviation News 1990. "Fit to fly" Canadian   General Aviation News, March 1990, page 28.  DHHS 1993. "Adverse Reactions Associated With Aspartame   Consumption," Department of Health & Human Services   Memorandum, April 1, 1993, Reprinted in preface of   "Bittersweet Aspartame: A Diet Delusion" by Barbara   Alexander Mullarkey, NutriVoice, DHHS 1995. Department of Health and Human Services. "Report on All Adverse Reactions in the Adverse Reaction   Monitoring System." (April 20, 1995).  Drake, M.E, 1986. "Panic Attacks and Excessive Aspartame Ingestion"   (Letter), Lancet, September 13, 1986, page 631.  Food 1986. Food Chemical News, July 28, 1986, page 44.  Food 1995. "Aspartame Adverse Reaction Reports Down in 1994   From 1985 Peak: FDA," Food Chemical News, June 12, 1995,   page 27.  GAO 1986. "Six Former HHS Employees' Involvement in   Aspartame's Approval," United States General Accounting   Office, GAO/HRD-86-109BR, July 1986. 
General Aviation News 1989. "NutraSweet...too good to be   true?" by Megan Hicks, General Aviation News, July 31,1989. 
Gordon, Gregory, 1987. "NutraSweet: Questions Swirl," UPI   Investigative Report, 10/12/87. Reprinted in US Senate   U.S. Senate Committee on Labor and Human Resources,   November 3, 1987 regarding "NutraSweet Health and Safety   Concerns." Document # Y 4.L 11/4:S.HR6.100, page 499. 
ICAS 1995. "Aspartame Side Effects: Fact or Fiction?"   International Council of Air Shows, February 1995.  Johns, Donald R., 1986. "Migraine Provoked By Aspartame," (Letter),
New England Journal of Medicine, Volume 314, August 14, 1986,    page 456.  Kessler, David A. 1993, "Introducing MEDWatch: A New   Approach to Reporting Medication and Device Adverse   Effects and Product Problems" Journal of the American   Medical Association 269:2765-68.  Lipton, Richard B., et al., 1989. "Aspartame as a Dietary Trigger of Headache," Headache, Volume 29, pages 90-92.  McCauliffe, D.P., K. Poitras, 1991.
"Aspartame-Induced Lobular   Panniculitis," Journal of the American Academy of Dermitology, Volume   24, page 298-300.
Monsanto 1994. "Monsanto Annual Report," 1994.  Moskal, Phil, 1990. Letter from Dr. Phil Moskal to George   Leighton, June 19, 1990, Reprinted in Deadly Deception Story of Aspartame: Compiled by the Aspartame Consumer Safety Network Founder, Mary Nash Stoddard, from volumes of available published information, (Odenwald Press 1998)
ACSN, P.O. Box 780634, Dallas, Texas 75378, (800) 969-6050. 
NBAA Digest 1993. "Operationally Speaking" by G. Dennis   Wright, Vice President of Operations.
NBAA Digest, Volume   6, Number 6, June 1993. Available from National Business   Aircraft Association, Inc., 1200 Eighteenth St., NW, Suite 200, Washington, DC 20036-2506, (202) 783-9000.  Novick, Nelson Lee, 1995. "Aspartame-Induced Granulomatous   Panniculitis," Annals of Internal Medicine, Volume 102, Number 2,   pages 206-207.  Pacific Flyer 1988. "This Could Save Your Life" Pacific   Flyer Aviation News, November 1988, 3355 Mission Ave.,   Oceanside, CA 92054.  Pacific Flyer 1995.
"ICAS Issues Warning To Its Members About Diet   Drinks," March 1995.  Pauli, George, 1995. FDA Center for Food Safety and Applied   Nutrition (CFSAN).
Radio broadcast: "Aspartame," The   Derek McGinty Show, WAMU Radio (88.5 FM), Brandywine   Building, The American University, Washington, DC 20016-   8082, (202) 885-1200, August 29, 1995. 
Plane & Pilot 1990. "Getting High" Plane & Pilot, January   1990, page 36-37. 
Roberts, H.J., 1988. "Reactions Attributed to Aspartame-Containing Products: 551 Cases,"
Journal of Applied   Nutrition, Volume 40, page 85-94. 
Stoddard, Mary Nash, 1995. Conversations between Mary Nash Stoddard of Aspartame Consumer Safety Network and   Mark D. Gold.  Turner, James, Leonard, Rodney, 1984.
Letter from Rodney E. Leonard   and James S. Turner of Community Nutrition Institute to Dr. Fank E.   Young, FDA Commissioner, September 13, 1984. 

Reprinted in   "Aspartame Safety Act," Congressional Record, Volume 131, No. 106, August 1, 1985, page S10841.  Turner, James, 1987. Testimony of James Turner, Esq.,Community Nutrition Institute before the U.S. Senate   Committee on Labor and Human Resources, November 3, 1987   regarding "NutraSweet Health and Safety Concerns."   Document # Y 4.L 11/4:S.HR6.100, page 316. 
US Air Force 1992. "Aspartame Alert." Flying Safety 48(5):   20-21 (May 1992).  USDA 1988. "1988 United States Department of Agriculture   Situation and Outlook Report; Sugar and Sweeteners."   Washington, DC: U.S. Government Printing Office, pp. 51.  WSJ 1996.  "Aspartame Critic Seeks More Research On Possibility of   Links to Brain Tumors," The Wall Street Journal, November 8, 1996.  Walton, Ralph G., 1986. "Seizure and Mania After High Intake   of Aspartame," Psychosomatics, Volume 27, page 218-220.  Walton, Ralph G., 1988. "The Possible Role of Aspartame in   Seizure Induction,"  Presented at "Dietary Phenylalanine   and Brain Function." Proceedings of the First   International Meeting on Dietary Phenylalanine and Brain   Function, Washington, D.C., May 8-10, 1987. Center for   Brain Sciences and Metabolism Charitable Trust, P.O. Box   64, Kendall Square, Cambridge, MA 02142. Reprinted in   "Dietary Phenyalalnine and Brain Function," c1988,   Birkhauser, Boston, MA USA, page 159-162.  Watts, Richard S., 1991. "Aspartame, Headaches and Beta Blockers"   (Letter to the Editor), Headache, March, 1991, Page 181-182. 
Wilson, Steve, 1985. "Sweet Suspicions," Television   broadcast and interviews regarding aspartame. Transcript in Congressional Record, Volume 131, No. 106, August 1,1985, page S10826-S10827.  Wurtman, Richard J., 1985. "Aspartame: Possible Effect on Seizure Susceptibility" (Letter), The Lancet, Volume 2, page 1060.

Mary Nash Stoddard


November 23, 2011

FROM: Miles McEvoy Deputy Administrator National Organic Program (NOP) 
SUBJECT: Request for Clarification of "Other Ingredients" in Processed Organic Products
November 23, 2011 Revision – Supersedes November 15, 2011 Version

The Organic Foods Production Act (OFPA) authorizes USDA to establish the National List of Allowed and Prohibited Substances. OFPA also grants the National Organic Standards Board (NOSB) the authority to recommend adding materials to or removing materials from the National List. The National List identifies substances that may and may not be used in organic crop and livestock production. In general, synthetic substances are prohibited for use in organic production unless specifically allowed, and non-synthetic (natural) substances are allowed unless specifically prohibited. For handling, the National List includes the non-organic substances that may be used in or on processed organic products. OFPA requires that the National List contain an itemized list of each permitted synthetic substance, including its specific use and application. The NOP recognizes that additional clarity is needed regarding non-agricultural ingredients used in processed organic products and listed under § 205.605.

When used as a formulated product, some substances on the National List may contain additional ingredients in various categories, including, but not limited to, carriers, stabilizers, and preservatives. Such "other ingredients" are sometimes referred to as inert ingredients, excipients, or incidental additives. For organic crop and livestock production, these "other ingredients" are specifically outlined in the regulations. For example, each ingredient in a livestock input material (e.g. medication, pesticide, feed additive) must meet one of the following criteria:
Nonsynthetic (natural) substance which is not prohibited on § 205.604. 
Allowed synthetic substances which is allowed on § 205.603. 
Synthetic inert ingredient which is allowed on § 205.603(e), if listed on the Environmental Protection
Agency (EPA) List 4-Inerts of Minimal Concern, and used in combination with allowed pesticide active
Excipient, only for use in the manufacture of drugs used to treat organic livestock if the excipient meets
one of the following criteria: ­ 
Identified by the FDA as Generally Regarded as Safe. ­ 
Approved by the FDA as a food additive. ­ 
Included in the FDA review and approval of a new animal drug application or new drug application.

Additionally, all agricultural ingredients listed in the ingredients list for feed additives and supplements must be organic.
1400 Independence Avenue, S.W. Room 2646-South, STOP 0268 Washington, DC 20250-0201

Request for Clarification of "Other Ingredients" in Processed Organic Products Page 2 of 2

For organic crop production, examples of products with multiple ingredients include blended fertilizers, pesticides with inert ingredients, and potting soil with wetting agents. However, each ingredient must meet one of the following criteria:
Nonsynthetic (natural) substance which is not prohibited on § 205.602. Synthetic substance which is allowed on § 205.601. Synthetic inert ingredient which is allowed on § 205.601(m), if listed on the Environmental Protection
Agency (EPA) List 4-Inerts of Minimal Concern , and used in combination with allowed pesticide active ingredients. For passive pheromone dispensers, substances on EPA List 3-Inerts of Unknown Toxicity are also allowed.

Currently, the allowance of "other ingredients" in substances on the National List for use in processed organic products is unclear. Several certifying agents and members of the organic trade have asked the NOP to clarify which "other ingredients" are allowed. Since OFPA requires that each non-agricultural ingredient be specifically allowed, and because the National List doesn't specifically list "other ingredients" commonly found in formulated products, the NOP is requesting that the NOSB specify whether these "other ingredients" are allowed.

NOP Request to NOSB
The NOP is requesting that the NOSB develop a policy on "other ingredients" in § 205.605 substances that is comparable to the comprehensive policy for crop and livestock materials. From this point forward, the NOP is requesting that the NOSB consider the presence of any "other ingredients" as part of their review processes. As substances on the National List come up for sunset review, or as new petitions are considered, the NOP requests that NOSB clarify whether any restrictions are warranted for "other ingredients" in § 205.605 substances. Any third-party technical report that the NOP provides will include information on any "other ingredients" commonly found in the substance under review.

The NOP is requesting that the NOSB specify any allowed "other ingredients" in the background section of their recommendations for substances recommended for listing on § 205.605, so that these allowances are clear to the organic trade, certifying agents, and the NOP. Any "other ingredients" that are not listed on § 205.605, or that are not referenced in the background section of the recommendation, would not be allowed in formulations of substances on § 205.605 that are used in or on processed products labeled as "organic" or "made with organic (specified ingredients or food group(s))".

The NOP recognizes that the NOSB may want to address the subject further in the future with a comprehensive policy for "other ingredients" that may be included in permitted handling materials. Some questions that could be addressed in a future recommendation could include the following:

1. Should all agricultural ingredients that are "other ingredients" be organically produced? 
2. Are synthetic preservatives allowed as "other ingredients?"

These steps will allow the NOP to clearly identify which formulated products are allowed under the processing section of the National List. Clear regulations will in turn allow certifying agents and the organic trade to consistently interpret these requirements. The NOP looks forward to working with the NOSB to continue to enhance the integrity of USDA organic products.

Mary Nash Stoddard