Roy Jobson
Roy Jobson

Simply Slim, sibutramine and synephrine

With tens of thousands of unregistered complementary medicines on the market, it’s interesting and surprising that the Medicines Control Council (MCC) recently ordered one product, Simply Slim, to suspend all sales and marketing until the MCC had had an opportunity to assess the product in terms of its safety, quality and efficacy. The decision was made at the very last Council meeting of the last incumbents on January 27 2010. A new Council has since been appointed. Perhaps we will see a few more of these products being scrutinised and not simply (sic) being made available to a largely uninformed public who are unaware of the pharmacological effects of a variety of active ingredients in these products.

Simply Slim certainly had a high profile and was widely advertised and marketed through a series of distributors. The initial advertising stated that the product would assist with weight loss without needing dietary changes or without exercise being necessary. This brought it foul of the Advertising Standards Authority and an ad-alert was issued against the company. The advertising was changed and the website subsequently included “wellness” information such as exercise programmes and eating plans.

A number of persons, however, were experiencing unusual side-effects after taking the product. This prompted a pharmacist to have the product independently tested — and the presence of sibutramine was found. Sibutramine was not listed as an ingredient of Simply Slim. Sibutramine is a Schedule 5 substance which means that it can only be made available on prescription from a medical doctor. The reason a doctor would prescribe sibutramine is because it has been proven to promote weight loss. It’s little wonder then that Simply Slim was so successful for many users. What the medical doctor prescribing sibutramine would know — and your average lay person distributor of Simply Slim would not know, is that there are contra-indications to the use of sibutramine. This is when the substance may not be used at all. These contra-indications include:

History of major eating disorders or psychotic illness; coronary artery disease, congestive cardiac failure, tachycardia, arrhythmias, uncontrolled hypertension, hyperthyroidism, prostatic hypertrophy, phaeochromocytoma, closed-angle glaucoma, epilepsy; history of drug or alcohol abuse; children under 18 years; porphyria. (South African Medicines Formulary)

A significant warning is that sibutramine should be avoided in combination with any substance likely to increase a person’s blood pressure. Synephrine is a constituent of “bitter orange” or “bigarade orange” (Citrus aurantium) which is listed as an ingredient of Simply Slim. Synephrine is likely to cause an increase in blood pressure and has been implicated in serious adverse reactions such as heart attack and stroke in Canada and elsewhere in the world. A case report was even reported in the South African Medical Journal in 2008 of a body builder who had a heart attack while using a combination of substances which included synephrine.

A combination of sibutramine and synephrine would probably make Simply Slim even more risky than when either substance is taken alone.

Department of health spokesperson Fidel Hadebe erroneously stated that synephrine is a Schedule 5 substance. This was unfortunately repeated in the Pharmaceutical Society of South Africa’s notice to its members concerning Simply Slim. A form of synephrine, meta-synephrine or m-synephrine, also known as phenylephrine is a Schedule 1 substance which does not require a prescription.

A number of weight loss products on the market contain synephrine and may well pose a risk to the public if persons with a predisposition to hypertension or other medical conditions take them. Consumers should check labels for bitter orange, Citrus aurantium or synephrine. Another name used for synephrine is oxedrine.

The sellers of Simply Slim have in the mean time announced that they are going to launch a new product. This sounds rather suspicious — but could also be interpreted as an admission that the previous product may well have been adulterated with sibutramine or had other shortcomings. We can only assume that the MCC will require evidence that the new version/product is safe, effective and of good quality before it will allow it to be registered as a medicine or made available to the public.

It is in the public’s best interest that the complementary medicines call-up notice should be rescinded. This misguided notice has enabled myriad products, including Simply Slim, to be marketed to unsuspecting consumers without any regulatory oversight and with no protection for the consumer. It was only after problems started surfacing that any action was taken against Simply Slim. A proactive rather than a retroactive, reactive system is urgently required — in fact this is the statutory duty of the MCC.

It would be interesting if any of those who were misled by Simply Slim could obtain recompense through the Consumer Protection Act and whether the apparently still-to-be-appointed National Consumer Commission would take action against the company and its directors and impose appropriately hefty fines. It could be a precedent-setting opportunity for the commission to establish its credibility and show that it is a body with teeth.

  • http://ionian-enchantment.blogspot.com Michael Meadon

    Good post, thanks. It’s high time the MCC starts regulating alt medicines and “supplements”.

  • Judith

    And “all medicines” must include everything including traditional ones

  • Lance

    Interesting post, if somewhat misinformed. Sibutramine did show up in SOME samples of Simply Slim, and not ALL samples of the product.

    Tests conducted by the SABS and other reputable and credible laboratories all indicated negative for Sibutramine, until recently. There is a great deal of suspicion surrounding the sudden appearance of Sibutramine in Simply Slim, as this is not part of the formulary of the product. It is believed that Simply Slim counterfeit product has been placed in the market with the distinct purpose of stopping Simply Slim.

    In addition, there are six forms of synephrine. Simply Slim contains para-synephrine, a natural product that is in daily use, and as stated earlier, is found in everyday products like Pineapple Juice and Marmalade. The “p”-form is generally referred to as ephedra’s “calmer chemical cousin” because it increases the body’s metabolic rate or ability to burn calories, without producing negative side effects on the central nervous system and the cardiovascular system.

    Your suspicion regarding Simply Slim’s announcement of a new product is unfounded. The counterfeiting of Simply Slim has necessitated that Simply Slim bring out their product with additional security features to ensure customer safety.

    And before you knock it, speak to the many people whose lives were so positively affected through the efficacy of Simply Slim.

  • Albert

    WELL SAID !

  • MLH

    I do wish the medical fraternity would start promoting more about what diet medication actually does to the body.
    I took Nobese for a few years, which obviously did me no good. I was eventually able to wean myself off it.
    But only when a doctor told me about 20 years on, that my metabolism had virtually completely shut down, did I begin to wonder what part the Nobese played.

  • Harris

    @Lance
    What absolute nonsense. The products that tested positive were purchased from Simply Slim distributors, who in turn got their stock directly from head office. Also, your argument that the synephrine in Simply Slim is “the ‘calmer chemical cousin’ because it increases the body’s metabolic rate or ability to burn calories, without producing negative side effects on the central nervous system and the cardiovascular system”, is contrary to scientific evidence. See World Health Organization’s Pharmaceuticals Newsletter: http://www.who.int/medicines/publications/newsletter/PN_3_2007.pdf

  • roy

    @Lance

    Thanks for the comments. In my view Simply Slim merely took advantage of a regulatory hiatus. It made medicinal claims and meets the definition of a medicine. It has also been called up as a medicine (as have all slimming agents)in terms of Regulation 25.2(32.3). It should have been registered in terms of the Act — not the flawed ‘complementary medicines call up’.

    I am interested in pineapple juice containing synephrine. Do you have a reference?

    Pineapples (Ananas comosus) are not the same at all as ‘pineapple oranges’ — a variety of sweet oranges (Citrus sinensis) which may well contain synephrine.

    Please note that we do not ‘generally’ refer to chemicals such as synephrine being ‘calmer cousins’ of other chemicals. This is misleading. But then the original advertising of Simply Slim also said ‘no chemicals’ — huh?

    Please do a clinical study rather than make a vague statement of ‘many people’ who apparently benefited from Simply Slim. You can [sorry, have to by law] apply to the MCC’s Clinical Trials Committee for approval.

  • Nici

    Simply Slim worked wonders on all people I personally know who used it.
    Most of the complaints came from people who never read the pamphlet inside the box.
    I believe that if you drank your 3 litres of water every day, you would not have had any of these symptoms. Also, if u read the warnings of possible lowered bloodpressure etc, and u still use it, I don’t think it’s fair to blame SS for your ignorance…
    I love SS and would use any new product again without any doubt…just hope it cheaper this time…

  • Lorraine

    Clearly Harris and Roy are scientists/pharmacists and not nutritionists Lance. Clearly you Lance know what you are talking about! If you study nutrition many of these “chemicals” occur naturally in various food substances. Particularly those of a plant origin…fruits, berries, vegetables, nuts etc. It is why these foods are good for us, as opposed to junk food! It is a well known fact that water and lemon juice on rising and retiring, or pineapple juice, as part of a healthy diet, promotes weightloss (Roy and Harris, read up on nutrition!) Others contain “compounds” known for their antioxidant properties or the ability to counteract free radicals.

    The problem with scientists Lance, is that if is natural, they cannot manufacture it, nor can they make money from it, nor can they schedule it and ensure that the distribution chain is limited to pharmacists only. A bunch of greedy con artists if you ask me! And hypocritical too, as they rush to market with the latest wonder drug without concluding their own trials… look at the osteoarthritis drug debacle in recent years… which had people dying of heart attacks and strokes before they withdrew it! LOL….
    I support Simply Slim (the original)Great product, no side effects, only available from agents. Make sure you used the product with the hologram packaging and not the one with the girl in a hat! The packaging of the counterfeit product has black on it instead of gold and was sold in PHARMACIES!

  • Lorraine

    As an addendum regarding the possibility of a clinical study. I would like to volunteer. I know of at least four other people (regular gym-goers and healthy eaters mind you) besides me who used this product with great success! I lost 11kgs in 4 months. It did not suppress my appetite, I had dry mouth and heart flutters only for the first three days. I followed the regime of six weeks on, two weeks off. I continued healthy eating and weight training(although not as intense as it was holidays). I continued to lose in the weeks off. I did not lose water, I lost inches of stubborn fat pockets that had been resistant to seriously heavy weight training and cardio. And I must add in all the right places. My body fat percentage has dropped, I have lost no muscle mass/inches, and achieved greater definition and cut. I feel fitter, more energetic and happy to have finally shed the stubborn kilos. I am back to the weight of my late 20s (I am 42 and had suffered a sluggish metabolism from stress, career, overwork, and lack of sleep.) I now sleep like a baby, wake up energised, and the healthy eating (no SS) continues to produce weight loss. I have a stockpile and will continue a SS maintenance plan of one week on per month. I have only a further three kilo’s to reach goal.

  • Lance

    @Harris – apologies for the delay in posting this reply. My references are the American Botanical Council – http://www.herbalgram.org, Bitter Orange Peel and Synephrine, by Mark Blumenthal. Full link:
    http://abc.herbalgram.org/site/DocServer/Bitter_Orange_Peel_and_Synephrine.pdf?docID=221
    @ Roy – I think I may have erred here and it may be Pineapple Oranges as per the linked article above.

  • Bernita

    The biggest problem is that the Sibutramine is not noted as one of the ingridients of the product, and as the product was only avialable through agents how was the product “hi-jacked” unless the SS agents found alternate suppliers to increase their margin, in both instances SS has to take responsiblity. However, if you take the product and start suffering side effects, surely you need to also be responsible and accountable for your own well being and stop taking it. There is a guarteed money back promise on this product. I do think that the suppliers and distributors of slimming products take advantage misleading people who want a quick fix. There is no quick fix that lasts. Lifestyle changes are necessary and these can be assisted with some of the products. Government needs to take responsibility for the loophole as there have been countless high profile media reports on these products and the like. Thank goodness something is being done about one of them at least with all the monies these companies make surely it should be mandatory for their products to be tested and given the stamp of approval by the relevant regulatory body, and then have to be subjected to quarterly audits of their products just like the financial services industry. If the agents are making a return of just over 59% GP how much does the manufacturer and distributor make? There must be more than enough money to subject to gov testing.

  • Me

    I used SS and it did not work for me, I am 4kg heavier than before my 3 boxes of SS. I had terrible side effects and Christal the agent that sold 2 boxes to me told me that the side effects will go away well it did not, I could not sleep was very moody and depro at times, I craved sugar (I normally do not eat sweets) I think SS took advantage of us to make a quick buck, I for one would like my money back. SS did fraud and they should be hold accountable for what they did selling a product to desperate people wanting the lose weight so they can get rich I mean buy it for R350 and resell for R590 I am now so upset with my friend selling me this product even more so that she is a nutritionist, saying that she endorse the product as it is 100% Healty.
    Let me know where and when can I start my legal action with SS…….false advertising, withhold serous drug information on the information pamphlet…..the list can go on and on…..see SS in court!

  • Pieter

    I am a pharmacist that formulates, designs and manufactures “complementary medicines” as a bussiness policy I stay out of the marketing and selling of the products that we manufacture. I do however do all in my power to ensure that the clients that I formulate / manufacture for stays on the right side of the law, this often is a diffficult task as most “sellers” do not know the law and are only interested in making a buck while they can, in those cases I walk away from it as I do not want to jeopardise my whole company. A problem that I have encountered often in the past few years is clarity on the law, no one seems to know, everyone makes reference to the act, ammendments, addendums, draft regulations, etc. Why is this not available on the DOH website as a final working version for everyone to see, that would clear a lot of confusion. I am also a great believer in regulating the manufacturer as most sellers and marketers have no pharmaceutical / medical / nutritional / health backgrounds and are therefore unable to make informed decisions with regards the legality of complementary medicines, a regulated manufaturer would however be forced to act within the law, and the illegal products would not be manufactured and sold, they would in fact never become available for sale to do any damage. It would clear the shelves of “ripoffs” and give good nutrition and solid supplements the credit that they deserve.

  • roberta

    Does anyone have an update on SS? Has the MCC lifted the ban on this product, and does the ‘newer’ version of the product show decreased side effects? This was very topical when the product was banned, but comments and news have died out. Thanks!

  • Esther Hartley

    Hi have not been able to use dieting products due to the fact that it would give me more heartpulpitations and lead to hyperventilations. I used SS very sucessfully had no pulpitations infact it stopped the palpitations and as I have given up all hope to ever loose weight again sucessfully I was pleasantly surprised with SS. I lost 10kg in first month had enless energy. Slept well felt good looked great! lost another 3kg came down from 42 dress size to 36/38 wearing jeans that I been dreaming for years to wear. Im now trying the NEW SS but the old SS product was definately much more effective. kind regards Esther Hartley

  • Pieter

    Roberta, have you tried contacting MCC? I am wondering who manufactures for Simply Slim, or is still an imported product?

  • http://google SHELA

    I used the original SS and lost 10kg in my first month with no side effects and had plenty of energy and enjoyed a good nights rest. Wish I could get in touch with someone who has had positive results using the new SS product. I see they also have a guarantee money back clause