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Why prenatal vitamins do not have fluoride

Here is a typical ~neutral position on prenatal fluoride:

(by Marjorie Greenfield, M.D.)

 

“Fluoride

 

Although fluoride protects developing teeth from cavities, the use of supplemental fluoride in pregnancy is controversial. Some studies have shown that children whose mothers received fluoride during their pregnancies developed fewer cavities; others found no benefit*. It's not known whether fluoride poses any risk to the fetus. As a general rule, it's best not to take fluoride beyond the small amount added to city water supplies.” [My emphasis.]

 

(*Here “no benefit” refers to Leverett’s study, which found 92% of the prenatal fluoride kids cavity free. That sounds like a pretty good benefit, but compared to 90% cavity-free from infant fluoride, it was not. “Ethics” would not let them withhold fluoride from the control group. Other articles use the phrase "no claims" one of which triggered my response below.)

Link to Dr. Greenfield's page http://www.drspock.com/article/0,1510,5124,00.html

No Claims?

 

            There is something that bugs me[1]. It is just an obscure phrase in papers about an obscure subject, but it grates on me. The subject is prenatal fluoride, and the phrase has to do with an old (1966)  FDA ruling[2]. The phrase that I think is completely misleading is saying the FDA only said the makers of prenatal fluoride could no longer make claims[3]. To me that sounds like prenatal fluoride could still be made and sold, it just couldn’t say anything good about fluoride. That is simply not the reality. When they made that law it was (and is) enforced to mean a product could not contain fluoride if it had the word pregnancy on the label[4]. That is a whole different story. That makes prenatal fluoride flat out illegal. So either somebody is reading the law wrong, or every body who writes about it is saying it wrong. The 1966 law on prenatal fluoride is not just “no claims”, it is an absolute ban.

 

            The rationale for interpreting the law as a ban might be that “pregnancy” in the label implies the nutrients listed are important for pregnancy. For example, an ad[5] for Natalins w/ Fluoride (Mead Johnson) makes two separate claims. One is for the nutrients in general, and the cite is essentially the RDA’s that say preggies need more of various nutrients. The second claim is for fluoride, which has a cite (but the cite doesn’t say much). OK so far, but not all the nutrients in prenatal vitamins are on the RDA list. It seems that other nutrients[6] besides the “preggie RDA’s” crop up from time to time on prenatal vitamins and nobody makes a peep, let alone raises a ruckus[7] like the dental lobby does when someone tries to put in fluoride. It was the dental lobby that made prenatal fluoride illegal[8].

 

            Let’s look at what the “no claims” law did to the availability of prenatal fluoride. In the table you can see that in 1967 there where 19 prenatal vitamins with fluoride that listed their brands in the PDR that year. Of these 19, 7 gave product information, and of these 4 made claims[9] the fluoride would be helpful, and 3 did not[10]. Whamo, the law hits, and in the next year’s edition those 19 products drop to 5, and none of them gave any product information, let alone made claims. Within another year or so all of them are wiped clean, except a few tricksters we’ll come back to.

 

            These prenatal vitamins with fluoride were becoming pretty popular[11]. In their short life (4 years, from 1962 until they were outlawed in 1966) I think they captured about 15% of the pregnancy market. (A historical note is that about 1960 is when people realized fluoridation wasn’t going to go much farther. That is another long, weird story[12]. I think some people had heard all about the wonders of fluoride, and were a little miffed that it was still being denied when they became pregnant. At the very least their doctors were following the story.)

 

            Most of the prenatal vitamins with fluoride just disappeared after the new law, but let’s take a look at the tricks used by a few to survive. This will also help prove that the law was more than just “no claims”. The vast majority of these products tried to go by the letter of the law and just not make any frank claims. This was not good enough: all of the products that tried saying fluoride and pregnancy, but nothing more, were goners. There were, however, 4 strategies that worked to some degree:

 

            1. Obscurity.  The “Natalets - F” by Saron never gave product information, and just sort of lurked in the background. They are listed, just as a brand, in the PDR until 1980. (The PDR has 4 indexes in the front, listing by company, by brand, by product category, and by ingredient; then a short picture section; then the bulk of the book is a listing of product info, in alphabetical order by company. If you only list by brand, the only way you could be seen is if some one knew your brand name, and they still could not find out anymore about your product.) Less obscure (since they are a big brand from a big company) was “Natabec w/ Fluoride” by Parke-Davis. They started the “brand list only” routine in 1969, combined with strategy #3 below. They were there almost 20 years, until 1988. (They did not have folic acid, perhaps to help disguise themselves, but I think that may be why they chose to bail out. See the note about folic acid in #2.)

 

            2.  A rose by another name.  “Adeflor M” by Upjohn in 1968 looks like a kiddie vitamin in the label, but has exactly the same nutrients and quantities as their “Adeflor Prenatal” the year before.  Eventually (I am not sure when) they stopped giving product information (things probably got cheesy with their giving 3 year olds all that iron, calcium, and folic acid), but they survived in the brand listings until at least 1985. Interestingly, this product survives to this day. It now is sold by Kenwood (Bradley), and I have not seen detailed product info. Somewhere along the way they shed its folic acid. I am happy there is a choice for prenatal fluoride and that a company is making money (it costs about 10% more than a normal $30 prenatal), but folic acid is important in pregnancy. In early pregnancy a lack of it can cause neural tube defects and later in pregnancy a lack of it causes anemia.

 

            3.  Stealth.  “Natalins Plus” sounds and looks like Mead Johnson’s regular prenatal, Natalins, perhaps with a little something extra. They added fluoride, there’s the plus, but they took away pregnancy! There is not a word about pregnancy on the label. It is for adults (children over 12), and look how they stretch the language to avoid saying “for pregnancy” and also avoid giving the excess nutrients to others: “Contraindications: Natalins Plus tablets should be used only by those people for whom supplemental vitamins, fluoride, calcium, and iron are all appropriate.” Natalins had left out folic acid originally (this is 1969), but by 1972 had slipped it in, at a very low dose (.1 mg). Mead quit this stealth strategy in 1975. (I will spare you my weird theory on why.) One interesting quirk of the stealth strategy is how far they had to go. One of the PDR listings (see #1 above) is by what the drug product is used for. Since the PDR is paid advertising, to have a fluoride product listed in the “pregnancy” category would break the law (as enforced). In 1966, the relevant heading was pregnancy, and the relevant sub heading was vitamins and minerals. In 1967 the headings were changed. Under “prenatal nutrition”, it says to “see under pregnancy”. There is still a pregnancy heading, but under various nutrients (like calcium), it says “see nutritional therapy”. Then, under nutritional therapy, there is no pregnancy or prenatal subheading  (but there are “pediatric” and other subheadings). The prenatal vitamins are just listed mindlessly. Even with all this accommodation, the stealth products (Natabec w/ F, Natalins Plus, Natalets F) are still not listed, here or in any category. In a few years (1971) the PDR went back to more rational listings.

 

            4.  Connect-the-dots.  This is a modern day strategy. “Bone Nourisher” is an over-the-counter product sold by L&H Vitamins. It provides calcium, fluoride, and other minerals for bones and teeth. They avoid the law against prenatal fluoride by saying it is for anyone, "including teenage girls and nursing mothers".  Note the gap - pregnancy.  ("Health Newsline", Sept/Oct 1994; 7(5):39.) Fluoride is legal for any group of people - grandmothers, newborns, apple pickers, truck drivers - any one except the group that is the most likely to need it: pregnant women.

 

 

 

            I think all of the nutrients in prenatal vitamins are important to the occasional woman who is deficient, but I don’t think any come close to the importance of fluoride. My guess is something like 95% of pregnant women are deficient in fluoride. And the value of giving your child a nice set of teeth is just immeasurable. The extra cost of fluoride in a vitamin tablet is zero. And fluoride does no harm (most measures, such as birth weight, show a slight positive trend from fluoride). Where’s the beef? There is obviously demand for prenatal fluoride, or these companies would not be so creative to find ways around an unfair law. These companies must know their business, and they must know what the law means. They survive only by not saying “pregnancy” and “fluoride” on the same label. That is a very stiff definition of “no claims”.

 

            So, what is the right way to say what really happened because of that law? It’s a little long, but how about something like this:  “In 1966 the FDA ordered an end to claims that fluoride in pregnancy could help prevent cavities in the unborn child. However, that law was enforced to prevent any product for pregnancy from listing fluoride as an ingredient on its label, even without any claims. This over-zealous enforcement took the fluoride out of about 20 prenatal vitamins. Prenatal vitamins are by far the most convenient and popular form of supplemental nutrition in pregnancy. To this day fluoride is still not a part of prenatal vitamins.”

 

 

 

 


 



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 RogersDiffusion 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.

 

Prenatal vitamins with fluoride in the PDR during the 1960’s

 

 

Product name

Company name

1967 PDR

1968 PDR

Notes

 

 

Brand Index

Product info

Claim[i]

Brand Index

Product info

Claim

 

 

 

 

 

 

 

 

 

 

Adeflor  Prenatal

Upjohn

B

1123

yes

B

*

 

*Fake: in 1968 morphed into Adeflor M with no claim, on page 1163[ii]

Capre-Flor

Marion

B

 

 

B

 

 

B in 1970, X by 1972

En-Cebrin w/ F

Lilly

X

 

 

X

 

 

 

Engran w/Fluoride

Squibb

B

 

 

X

 

 

 

Filibon w/ F

Lederle

B

706

no

X

 

 

 

Flornatal[iii]

Sherman

B

 

 

X

 

 

 

Flura-Pren

Kirkman[iv]

X

 

 

X

 

 

 

GravaVite F

Hoyt

X

 

 

X

 

 

 

Natabec w/ F

Parke-Davis

B

914

yes[v]

X

 

 

Returned as fake prenatal ~1969[vi]

Nataflur

Reid-Provident

B

 

 

X

 

 

 

Natalets-F

Saron

B

 

 

B

 

 

B until at least 1980; X by 1982.

Natalins w/ F

Mead Johnson

B

823

yes

X

 

 

Returned as fake prenatal in 1969[vii]

Obid-F

Ingram

B

 

 

X

 

 

 

Obnatal - F

Boyle

B

555

no

X

 

 

 

Obron F

Roerig

B

994

yes

X

 

 

 

Palminate F

Palmedico

X

 

 

X

 

 

 

Pramet w/ F

Abbott

B

520

no

X

 

 

 

Pre-Flur

Tutag

B

 

 

X

 

 

 

Prenflor

Drug Ind

B

 

 

B

 

 

X in 1970

Prenatal-Federal w/ F

Federal

B

 

 

X

 

 

 

Pre Obin F

Person & Covey

X

 

 

X

 

 

 

Prevam w/ F

US Vit & Pharm

B

 

 

X

 

 

 

Stuart Prenatal - F

Stuart

B

 

 

B

 

 

X in 1970

Vio-Prenate w/ F

Rowell

B

 

 

X

 

 

 

 

 

 

 

 

 

 

 

 

Totals:  

24

19

7

4 yes

3 no

5

none

 

3 B’s hangers-on, 2 B’s long term, 3  fake prenatals

 

In the Brand index column, “B” means listed, “X” means it was not.  In Product info column, the numbers are the page numbers where the product is described. In the claims column, a “yes” means there is an explicit claim about fluoride or that the product will help the unborn child’s teeth.

 

Prenatal vitamins with fluoride that are known, but not listed in the PDR: Flur-Add by Bernkopt and Flor-Pren by Argus. (See Wurdack  J Amer Phar Assoc  Feb 1965; N.S.5(2):95-102). There were also generic fluoride products. There were also prenatal products with “occult” (not listed) fluoride, mainly from the use of bone meal as a source of calcium. In Feltman’s list (Northwest Medicine  June 1956; 55:663-4) there were 7 products that provided about .2 mg F.



 

 

 

 

 

 

 

Basics of prenatal fluoride http://raygrogan-ivil.tripod.com/pnf

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