Endnotes

(Some of these have deep gory details that only a nut would want.)

[1] Ray Grogan  October 31, 1997  /  (2005 address)  2608 Court St /  Iowa City  IA 52245-4801 USA  //  (319) 321-5685  //  raygrogan@hotmail.com

[2] FDA. Oral prenatal drugs containing fluoride for human use. Federal Register  Oct 20, 1966; 31(204):13537. Amendment to 21 CFR  3.53: (a) The food and Drug Administration finds that there is neither substantial evidence of effectiveness nor a general recognition by qualified experts that prenatal drug preparations containing fluorides are beneficial to tooth development in the fetus or in the prevention of dental caries in the offspring. (b) Any such drug preparation that is so labeled, represented, or advertised will be regarded as misbranded and subject to regulatory proceedings unless such recommendations are covered by a new-drug application, including substantial evidence of effectiveness, approved pursuant to section 505 of the Federal Food, Drug, and Cosmetic Act. (cont’d).

[3] The first version of “no claims” hit the drug press within a month: American Druggist  Nov 7, 1966. Under the headline “FDA moves against prenatal fluorides”, the story says, “In the ... action, which involves about 20 products, FDA ordered an end to claims that, because of their fluoride content, the preparations in question aid in the development of teeth in a fetus, or help prevent cavities from occurring after the infant is born.” Just recently, the notion is the same, coming from the people who keep prenatal fluoride illegal: In Leverett’s trial of prenatal fluoride he states that the FDA moved to “... ban manufacturers of fluoride supplements from making claims that the products would prevent caries in the offspring of women who took the supplements during pregnancy.” (My emphasis.) Note that both the law above and the articles about it specifically say that it is claims about the fetal teeth that are the problem. Neither say just having fluoride in a product labeled for pregnancy is illegal.

[4] Another, later FDA ruling that is probably relevant: FDA Drug Bulletin Dec 1973. “No US RDA has been set for essential nutrients that are not appropriate for addition to general purpose foods for dietary supplements. These nutrients include choline, vitamin K, chlorine, fluorine, manganese, potassium, sodium, and sulfur. They may be added to special dietary foods such as infant formulas and to other foods for use solely under medical supervision to meet nutritional requirements in specific medical conditions.” I am not sure if this says fluoride is OK for pregnancy or not. It looks like it would be, but notice the catch 22. It would have to be for a specific medical condition, i.e., specify pregnancy on the label, which would run into the older law. Also note how fluoride is singled out. The US RDA list of OK nutrients still does not include some trace elements for pregnancy (such as the 3 just below) that are in some prenatal products. More recently, fluoride almost got it’s “RDI” along with chromium, selenium, and manganese, but was pulled from the list at the last minute. I looked, and could not find out why (I bet a six-pack it was the dental lobby). (It should be noted that there are at least 6 different sets of government guidelines on nutrition, the RDA’s, the US RDA’s, the MDR’s, the ESSADI’s, the AI’s, and the RDI’s. I am not clear on the differences.)

Although the FDA won’t let drug makers talk about prenatal fluoride, the ban apparently does not apply to themselves. Here is a little bit out of one of their own publications: “If babies receive fluoride from the start (even when still in the womb), while their teeth are still developing, and continue to do so all through formation of both their baby teeth and the permanent set, stronger teeth will erupt, teeth that are more resistant to attack by decay-causing bacteria. ” FDA Consumer Jan-Feb 1992 page 134. An article on how to have healthy teeth by Dodi Schultz.

[5]American Druggist  Jan 7, 1963, page 30. The fluoride claim says “To supplement the nutritional elements necessary for the formation of sound and healthy teeth in the unborn child.” (Note the claim they’re so upset about doesn’t even mention fluoride per se. Other nutrients in the product, such as vitamins A and D, are also essential for teeth formation.)

[6] Like the 1980 RDA’s for pregnancy still do not give anything extra for many trace elements, such as copper, manganese, fluoride, chromium, selenium, and molybdenum. Back in 1967 the Filibon prenatal has both copper and manganese, and the FDA did not get on them about that. I have seen all of these nutrients in prenatal vitamins.

[7] For example, a fine pompous attack/threat on prenatal fluoride was made in 1963 by none other than Joseph Muhler, the inventor of Crest toothpaste (he made millions on the patent). “This [adding fluoride to prenatal vitamins] is undoubtedly the greatest abuse of fluoride therapy ...which may ultimately result in drastic restrictions being placed on the use of fluorides by the federal government ... [and an increase in antifluoridationist activity].” J Amer Pharm Assoc Mar 1963; N.S.3(3):133-4. (At the time, some dentists were leading the pro-fluoridation movement, mostly against other dentists who were leading the anti-fluoridation movement. It was a stalemate. Fluoridated water prevents about 50% of tooth decay; and toothpaste prevents about 20%. I think dentists already knew intuitively what would be more widely known later, that prenatal fluoride would stop almost 100% of cavities.

[8] Here is a direct quote: “... dental research experts have played a crucial role in advising the FDA on the efficacy of fluoride products. In the 1960’s the FDA Advisory Committee on Fluorides was composed of a number of experts, including Herschel Horowitz, at the National Institute of Dental Research (who is with us today), and Earnest Newbrun, at the University of California at San Francisco. ...  Are there any FDA restrictions on the use of fluorides? The answer is “yes, particularly with regard to indications. In general, the FDA has only approved claims to prevent and treat all kinds of dental caries, whether due to conventional or stress conditions, on coronal or root surfaces, in infants, in children, in teenagers, and in adults of all ages - with one exception.... This relates to claims that ingested fluoride will prevent caries in pregnant women or that prenatal fluoride will augment postnatal fluoride benefits in their offspring. ... Both the FDA and ADA concur on the proof of safety of ingested fluoride, whether from drinking water or from supplements, with regard to pregnancy.” Grodberg MG. Professionally applied and prescribed fluoride products. Journal of Public Health Dentistry 1992; 52(6):346-9.

There is also a quote to tie in a third dental lobbist in making prenatal fluoride illegal: “Dr. Carlos would like to separate NIDR from past misdeeds. In 1966, NIDR dentists, including Dr. Carlos, organized and largely staffed the FDA ad hoc committee that declared PNF mislabeled. NIDR then had all the committee records destroyed so they could say, “the FDA did it”. Since 1962, Dr. Carlos’ NIDR has used its considerable power to keep children’s teeth fluoride deficient: contrary to established principles of nutrition, a priore reasoning, six classical water fluoridation studies, and ten fluoride tablet supplement studies.” Glenn FB, Glenn WD. Efficacy of prenatal fluorides reaffirmed: authors’ reply. Letters. ASDC Journal of Dentistry for Children  Mar-Apr 1988; pg 94-5.

Now, for a quick jump to the ~present to see how the dental lobby treats prenatal fluoride, here is what happened a few years ago: At a conference Herschel Horowitz communicated very effectively with silence. One of the papers to be read (by JA Hargreaves) had mentioned the studies of Dr. Glenn in a review of fluoride experiments. I called Dr. Hargreaves, and he said he was having a health problem and could not attend, but “Hersch” would give his paper. When Hersch got to the offending paragraph (see below), you could have heard a pin drop in that auditorium. Hersch paused dramatically, then skipped the paragraph and went on reading the paper. During the rest of the workshop - which was specifically about fluoride supplements - everyone pretty much followed Horowitz’s example and just did not talk about prenatal fluoride or Dr. Glenn. Here is the offending paragraph: “Glenn [list of cites] examined immunity conveyed by a fluoride supplement during pregnancy. Although suggesting that pre-natal fluorides are beneficial in reducing dental caries, concerns about uncontrolled aspects of her studies were expressed by Edelstein (1979) and others and the findings that Glenn published need to be repeated using sound scientific principles.” (At the same meeting Horowitz also announced that the ADA had accepted fluoride vitamin combinations [after 30 years of denial] in order to get some control over their ads via the ADA seal of approval.) Horowitz HS. Unpublished remarks as remembered by Ray Grogan at a workshop 4/23/1991 UNC Chapel Hill, Changing patterns in systemic fluoride intake.

Just a few weeks ago (Oct 17-19, 1997, ECC conference, Washington DC) Horowitz et al were at it again. The conference was on nursing caries (a type of tooth decay that ravages the baby teeth). If there is any time fluoride might help these teeth, it would be prenatally, or maybe infancy. The former is illegal, and the latter was taken away by the ADA. In two days of jabbering, with no good solutions suggested, the only mention of prenatal fluoride was by Dr. W. Darby Glenn, and they basically cut him off and did not answer his questions. (My memory again.)

[9] What I call claims, such as Adeflor Prenatal’s “...to help provide an optimum amount of fluoride during the period of tooth development in the fetus.”

[10] No frank claims, as above. For example, Filibon with Fluoride (prenatal tablets) by Lederle (1967 PDR pg. 706) makes no mention whatsoever of teeth, cavities, etc. It just says the fluoride is there, and watch out for too much.

[11] In the pharmacy journals there are a few articles about how well the fluoride products were selling. In American Druggist there’s “12 Vitamin-Fluorides Marketed in 1962” (Jan 1963, pg 31), and an ad for Natalins with fluoride nearby. A few years earlier (Aug 21, 1961, pg 33) there is a good general article on fluoride and some of the new products (mostly pediatric, but the article cites Critchton-Browne’s prenatal recommendation).

[12] You can find two different versions of antifluoridationist activity. (Not counting a third version from the anti’s.) From people who study social change, it was an interesting case where science and common sense lost to ignorance and fear. When they tell the story, they almost snap to my opinion, that it was largely a stage show between pro and anti dentists. They do note that the anti’s were led by a small and secretive group of dentists from out of town. And they note the dental profession should be expected to be ambivalent about something that would cost them business. (For a quick summary, see Rogers’ Diffusion of Innovation, the 1963, page 15. The dental details are in the Journal of Social Change 1961; 17(4):1-82). On the other hand, when the dentists tell the story, you don’t get the part dentists played in the anti  groups. (For example, see Newbrun’s version in Journal of Public Health Dentistry 1996; 56(5 spec rv.): 246-52). If you go on the Internet today, it is full of anti-F dentists. There are 6 points that both the antifluoridationists and the dental lobby agree on completely: (1) fluoridated water is a big spooky controversy, (2) to fluoridate or not should be decided by the general public, (3) dental decay is not important and is going away anyway, (4) fluorosis is a big problem, (5) minimize the fact that fluoride supplements work great, and (6) that prenatal fluoride should remain illegal forever.