NOTE: This article is a bit dated, from 1997, and there are some changes. For example, stevia can now be sold legally as a "dietary supplement" but not as a "food additive." This peculiar distinction is due to the dietary supplement law (DSHEA) which allows supplements sold before 1994 to remain on the maket unless the FDA can prove they are unsafe. FDA still won't allow stevia to be sold as a food ingredient or sweetener, but the distinction is nearly meaningless, as stevia "supplements" are now sold in green packets that look a whole lot like the pink and blue packets that contain sweeteners. The FDA's stubborn position, though, prevents stevia to be used to sweeten soft drinks or foods, where this safe natural plant extract could replace the less healthful chemical sweeteners now used.
Also, PPA has now been banned in diet products and cold remedies. Ironically, PPA was the only diet aid approved as "safe and effectie" by FDA. Oops. Now it seems that PPA has been causing bleeding in the brain in some of those using it, and reports of this serious toxicity have been know for 20 years. Ironically, ephedra and other herbal supplements are now the only legal diet aids available without a prescription.
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: