Controversial Products in the Natural Foods Market
by Rob McCaleb
President, Herb Research Foundation
The New Hope Communication's annual Winter Networking Conference
was held February 1-4. in Breckenridge Colorado. For those unfamiliar
with the Conference, it is one of the most enjoyable, relaxed
and fun events in the natural products industry. The program is
getting better every year, and oh yes, the skiing isn't too shabby.
At this year's conference, I led a diverse group of retailers,
distributors and natural product manufacturers in a roundtable
discussion of controversial products in the marketplace. While
there was not time for a thorough discussion of all such products,
we probably at least named the major items. The products which
generated the most interest and questions were (in no particular
order) stevia, ephedra,
melatonin and sugar,
including especially
organically grown sugar. It is interesting that the major topics
of controversy are uppers, downers, diet pills and sweeteners,
the same kinds of products which are controversial in the mass
market
In the first two sessions, attorney Bill Appler discussed
the nature of regulatory controversies, which he said, come and
go. The hot topic last year may well not survive into this year.
He also updated us on the ongoing deliberations about ephedra.
Ephedra was at risk of being
banned from sale over the counter
by several states, including Texas. After
a meeting with industry representatives, the FDA seemed to be
leaning toward a position remarkably similar to that which the
industry has already taken. AHPA recommended to its members over
a year ago, that they label ephedra products with appropriate
warnings and limit the maximum dose, both per unit, and per day.
Many companies have already complied. Ephedra is still controversial
to retailers, however, because the products are not widely considered
to be very healthful. Some felt that the use of fast-acting stimulants
and diet pills was contrary to the principles of those committed
to healthful lifestyles, proper nutrition and exercise. Others
pointed out that consumers demanded and expected them to carry
these products and that it was a consumer choice to use or not
to use them.
Melatonin is another product which was questioned on issues
of consumer safety, and also the question of whether this is the
kind of product which "should" be offered in the natural
foods store. Melatonin is, after all, a synthetic hormone. Some
scientists and physicians have questioned its safety, especially
for long term use. There is no evidence that it is unsafe,
actually, only questions because it has not been used for very
long. Some are suggesting that the dose should be lower than those
currently common on the store shelves. Today's products are usually
3 mg, with some doctors now suggesting that they should be below
1 mg.
Sugar, in general, is also a product which still generates
controversy in natural food stores, from the standpoint of "should
we be selling this at all?" Organic sugar is controversial
only because, reportedly companies who have been polluting for
years are now selling organic sugar. Some feel this "now
we're green" position is just a marketing scam and should
not be supported. Organic food guru Tom Harding thinks otherwise.
He points out that conventional sugar production is very toxic
to the environment, and this is a good trend, which should be
encouraged. As the market grows, he hopes that more sugar-producing
companies will shift production into organic, even if they are
currently major polluters. Wouldn't we rather they be "former
polluters"?
Stevia is a subject which always generates many questions,
for a number of reasons. People were particularly interested in
the current legal status of this embattled herb, which has been
under FDA import alert since 1991 as an "unsafe food additive".
Actually, according to the HRF, numerous scientists, and tens
of millions of consumers throughout the world, especially in Japan,
the herb is safe and intensely sweet, which could make it a popular
non-caloric sweetener. That's the problem, apparently, because
someone (FDA won't say who, but it's a big company) doesn't
want it on the market, and convinced FDA to ban it. Now, the Dietary
Supplement Health and Education Act of 1994 has forced FDA to
allow it in dietary supplements. The agency says it's still illegal
to use it as a food ingredient, placing them in the rather stupid
position of saying it's safe if labeled as a supplement, but not
when sold in or as a food. This would seem to violate the famous
"Hee Haw" rule implemented by former FDA Commissioner
Frank Young. Dr. Young implored his managers not to place the
agency in a position which made it appear foolish by violating
obvious common sense. The rule was reportedly prompted by the
FDA's case against ginseng capsules years ago. A judge told the
Agency that the position that ginseng was safe as a tea but dangerous
in a capsule was ridiculous. Now they say stevia is safe in a
capsule, but not in a tea, unless the tea is labeled as a dietary
supplement. Go figure...
Stevia is now available in the form of teas, powdered leaves
and liquid extract, for dietary supplement use, of course. Even
before the import ban was lifted, the liquid extract was available
as a cosmetic masque (you were supposed to mix it with clay and
put it on your face--uh huh, right).
Diet teas are another perennially controversial product. Some
are based on ephedra (ma huang) or its major active principle
ephedrine, caffeine (often from kola nuts=bissy nut, guarana,
tea or mate) and sometimes aspirin or willow bark. They are supposed
to be "thermogenic" causing us to burn fat faster. There
is some scientific support for this. Whether or not they do, stimulants
are appetite suppressants, and this may be a more relevant effect.
Ephedrine works exactly like the FDA approved appetite suppressant
phenylpropanolamine (PPA) which is the active ingredient in Dexatrim.
Other diet products, especially diet teas, are based on laxatives
and diuretics. These are controversial because they may only produce
temporary, illusory weight loss through dehydration. Additionally,
stimulant laxatives like senna and cascara sagrada are not healthy
for regular use, because they are habit-forming and can cause
side effects, sometimes life-threatening. Like anything which
causes water loss from the body, they can deplete electrolytes
and potentially cause cardiovascular problems including increases
in blood pressure. Obese people who suffer from hypertension would
have more risk than the general population, but daily use of stimulant
laxatives is a bad idea. As one retailer commented "Even
allopathic doctors and pharmacists know this isn't good for you.
What are we doing selling this stuff?"
Here's the entire list of controversial products mentioned
in the roundtable:
- Comfrey - contains liver toxins called pyrrolizidine
alkaloids. Some feel it's safe for most people, others see no
point in taking any risk if other herbs can offer similar benefits.
Roots have more alkaloid than leaves, and young leaves more than
older leaves.
- Chaparral - also implicated as a liver toxin, but without
strong evidence. Reported cases of human toxicity are complicated
and rare, no liver toxic compounds have been identified, and the
FDA, which has done some feeble testing with cultured liver cells
but no classic toxicology testing, has been unable to come up
with compelling evidence of harm.
- Stevia - the embattled sweet herb, banned for 4 years
based on a "trade complaint" (ie from a company, not
a toxicologist), is now available as a dietary supplement. Looks
safe.
- Ephedra - after over 5,000 years of human use, the
herb is controversial because of abuse in diet and energy products
and the use of strong concentrates in products. Some products
contain synthetic ephedrine, just like asthma drugs.
- Laxative diet teas - can be habit-forming and produce
unhealthful side-effects. Weight loss from such products may be
mostly by dehydration, hence not lasting.
- Stimulant diet teas - mostly ephedra, caffeine sources
and sometimes willow or aspirin. They probably are appetite suppressants,
and may stimulate fat burning. Some individuals should not touch
them, for others there are questions about safety and healthfulness.
- Cleansing programs - many are based on stimulant laxatives,
which can be habit-forming. The concept that we need to use laxatives
to "clean out" is controversial.
- Hemp - more products are appearing using the seed oil,
which lacks the intoxicating components of the plant, also known
as marijuana. No toxicity concerns, but the plant is controversial
for obvious reasons.
- Kombucha "mushroom" products - evidence of
benefits is weak. Concerns have been raised about safety of growing
your own. The "brew" produced by this complex of microorganisms
contains mostly vinegar, sugar, a bit of alcohol and caffeine.
- Kava kava - becoming popular as a sleep aid and anti-anxiety
agent. Concerns are about potential regulatory issues (no problems
so far) and possible abuse.
- Grape seed extract / Pine bark extract / "Pycnogenol"
- are confusing to consumers. What are the differences? Is one
better? Grape seed extract predominates in the European market,
while pine bark extract is stronger in the USA, probably because
of better marketing.
- Evening Primrose Oil / Black Currant Oil - are sources
of the fatty acid gamma linoleic acid or GLA, beneficial to the
cardiovascular system and reportedly effective for PMS and inflammatory
conditions. FDA tried to claim that they were "unsafe food
additives" but never had a shred of evidence of harm. The
Agency lost (badly and repeatedly) in court.
- Melatonin - synthetic hormone to induce sleep. Long
term safety is uncertain, but it is produced naturally in our
bodies.
- Tryptophan - still off the market because of a quality
problem with one manufacturer which led to illness and some reported
fatalities. No one expects it to return to the market, but under
the Dietary Supplement Health and Education Act of 1994 it would
apparently be considered a safe and legal supplement unless FDA
could prove otherwise.
- Chromium picolinate - widely sold in diet and muscle-building
products. Does it work? It's an "insulin potentiator"
which may improve some metabolic factors, but needs more research.
- Beta carotene - the recent report by NIH that it doesn't
help and may increase cancer risk (in smokers) is raising questions
among consumers. The weight of evidence seems to support this
antioxidant, and there are serious questions about the study,
which combined beta carotene with vitamin A (retinol) at toxic
levels, then gave it to smokers who are already at risk. Nature
provides vitamin A (in fruits and vegetables) in the form of 90%
beta carotene, and at lower doses than those used in the study.
- Single amino acids - including tryptophan, phenylalanine,
aspartic acid and others, are controversial because they are isolated
and taken in high doses. Safety may be a concern.
- Germanium - rose to popularity, then declined as cases
of toxicity were reported. Germanium is only healthful in very
low doses.
- Selenium - same issue as germanium, complicated by
the fact that areas with high selenium levels in the soil produce
selenium-rich vegetables. In those areas supplementation is not
necessary and could be hazardous.
- Organic Sugar - is this just a way to "sugar-coat"
something that really isn't healthful? Is the "green marketing"
aspect exploitive? See above for details
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