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SweetJade1980

S.B. 3002 Dietary Supplement Safety Act of 2010

For or Against DSSA 2010?  

11 members have voted

  1. 1. How do you feel about this newly proposed bill?

    • I support S.B. 3002 DSSA 2010
      4
    • I oppose S.B. 3002 DSSA 2010
      5
    • I am undecided about S.B. 3002
      2
    • I need more information about S.B. 3002
      0


Bill would force disclosure of ingredients and register with the FDA

Dietary Supplement Firms Fight McCain

That initial statement sounds relatively harmless, who doesn't want to know exactly what they are taking? Who takes a supplement without knowing what is in it? You are more likely to take a prescription drug in a white bottle with no indication of ingredients before you would take a supplement in the same dubious packaging. Although, you can always go online and find the ingredients of your particular prescription drug. However, most supplement manufacturers do label their products with all ingredients listed, especially if they follow GMP (Good Manufacturing Practice regulations). The only hangup I've seen is the listing of "natural flavorings." For someone with food sensitivities, that can be dangerous. Are we to assume it is flavored based on the name (i.e. strawberry banana) or could they use other flavors as well? That is something I would like full disclosure on, but the FDA allows that type of labeling.

The other concern is registering the products with the FDA, this seems to be where the opposition is coming from manufacturers and even retailers. This would require a lot of documentation on these industries, to the point where, yes, the smaller manufacturers and retailers may close down. The tactic used to make this part of the bill seem reasonable is that of the past and potential deaths resulting from suppelementation. Again, anything with that type of potential should be noted and regulated, but the overwhelming majority of supplements do no kill people and have minor side effects, especially when you compare those numbers to prescription drugs. Granted, there are substances that people can also be allergic too, which again is something that should be noted, but not a reason to remove it from the market.

Another major concern with this act would be the regulation of dosages. This is the one that is not outlined as specifically happening, but if the FDA has more power and with the record keeping, there is potential that they may do this in the future with the power this bill would give them. That would mean...all of us would be SOL if the FDA got it's hands on the supplements we use to help us detoxify, repair, reduce inflammation, etc all with the final goal of acheiving clear skin (and good health). So, for example, the FDA could limit us to taking only 100 mg of supplement, when we know it takes 2000 mg - 5000 mg for it to be effective. Of course, the rationale for that would be, that it is unneccessary to take such high amounts, the product might have side effects at such amounts, or that's a therapeutic dose needing to be regulated.

You are certainly welcome to your own view points on this, but if you would like more information, please review the links below:

Senat Bill 3002

Track Bill Progress

Your Right to Buy Supplements is Threatened by Senate Bill S.3002

9 Reasons Senate Bill 3002 Has To Go

By James Gormley, Senior Policy Advisor, Citizens for Health

More Info @ The Gormley Files

1. No phase-in period or “effective dateâ€. Since legitimate dietary supplement companies and health-food stores would not have even one day to come into compliance with the new law, they would effectively be breaking the law the day after S. 3002 is passed.

2. Registration of supplement licensors. S. 3002 would require outfits that license dietary supplements to register their “facilities†under the FDA Food Facility program established by the Bioterrorism Act of 2002. Including these requirements would go against the purposes of the Bioterrorism Act and would serve no useful purpose other than creating more bureaucracy and red tape.

3. Registration of health-food stores. S. 3002 is unclear as to whether the current retailer exception to the Bioterrorism Act registration requirement is intended to be honored for supplement retailers.

4. Product and ingredient registration. The product/ingredient registration process included in S. 3002 is unclear in its use of the terms “ingredients†and “labeling.†As worded, S. 3002 would apparently require duplicate, therefore unnecessary, registration of every product at every point in its distribution! This would be an incredible burden, one that would mandate annual updates, and one that would not protect any proprietary information that is not required on product labels but that that may be required to be submitted in the registration process.

5. Replacement of new dietary ingredient (NDI) requirements with an FDA positive list. FDA received information between 1996 and 1998 from dietary supplement trade associations to record ingredients believed to be marketed in the U.S. prior to the passage of DSHEA. If there is any lack of clarity as to what dietary ingredients are “old,†the agency should initiate rulemaking to formally adopt the ingredients directly submitted by the trade associations.

6. Retailer evidence of compliance. The bill’s proposal to require health-food stores to obtain evidence of compliance with product registration and NDI notifications is would be ridiculously burdensome and something that is not required for other regulated goods.

7. Civil penalties. The bill would establish new, unnecessary civil penalties despite the fact that current law already imposes adequate fines and penalties for violations of the Food Drug and Cosmetic Act.

8. Non-serious adverse event reports. The FDA itself has made it clear that it would not be helpful for the agency to receive boatloads of minor or trivial (and probably not substantiated) adverse event reports associated with dietary supplements. Under current law, dietary supplement companies are already required to maintain records of all adverse event reports for 6 years and the FDA has the authority to inspect these records at any time.

9. FDA recall and “cease distribution†authority. S. 3002, as well as other food safety legislation already introduced in the 111th Congress (such as S. 510), would provide FDA with authority to mandate products recalls when health risks are presented by marketed products, which is fine. However, what is not fine is that S. 3002 would obligate the agency to issue a “cease distribution†order for any supplement identified as adulterated or misbranded, even in the absence of any perceived health risk.

Edited by SweetJade1980

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Thanks for the post, SJ! The FDA is only about pharmaceutical industry profits, their main goal is not to honoustly educate people about alternatives. Hell, I've read so many stories about the way the FDA is on the leash of these pharmaceuticals, it's unbelievable. Recently they even kidnapped doctor Caton, a herbalist living in Nicaragua (source: naturalnews.com). He has great success treating cancer with natural medicines, but the FDA -surprise surprise- couldn't tolerate that. FDA = white collar mafia. Anyone with common sense should vote against this bill.

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I think it's a fantastic idea and long overdue. I want to know what is in them. I want to know that I am getting what I think I am getting.

Dosage levels won't be affected. There is a dosage indication for Tylenol, but you can take whatever amount you like.

Everyone demonizes the Pharm industries, but do you REALLY think supplement companies care about you?! Supplement business is huge! They scam people all the time. They make outrageous claims that everyone believes. It's all such a racket and sometime a scam. They are no better than pharm. For some reason people believe they care about them....why?

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I think the pharmaceutical industry feels threatened by the natural alternatives that are becoming more and more popular (ie. a little research on the internet can bring you many wonderful alternatives to a drug sold by a pharma company). Health food stores selling alternatives are springing up everywhere.

Wasn't it the FDA who (under the pressure of Pepsi who controlled the chemical sweetener Aspartame) illegalized Stevia and had the Stevia office raided and all paperwork inside burned? Wasn't that a bit extreme? Even though Stevia has been legal and used safely in all carbonated beverages in Japan for 80 years. But the FDA made it illegal for Stevia to be even used in the US because it competed with Aspartame.

So, although it would be nice to have supplements listing their ingredients (but they already do!!), I really think the FDA is under pressure from another large company in the background because someone is feeling threatened. Lots of paperwork for the tiny Health Food Stores means less interest in opening more health food stores. Therefore, less competition for the pharmaceutical companies.

Edited by Dotty1

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WE WON!! WE WON!! WE WON!! WE WON!! WE WON!!

McCain backed down :)

Anyway SJ, WELCOME BACK! And I just wanted to ask a few Q's if you don't mind because I know you are so in demand on the boards, I need to take this opportunity to ask some pressing questions I've been wanting to ask. :'(

I think I have SAHA (seborrhea, acne but no hirsutism im a guy):'(

Is there any specific supp I could take besides increasing Insulin Sensitivity?

Also re: 5-AR inhibitors, it can give male breasts and belly fat as a side effect. Any workaround on this? :'( I can only think of Aromatase Inhibitors but those in turn give hair loss :'( WHAT TO DO!!!?! :'(

Edited by rentstuff

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Okay, F*CK this crazy ass law. Wouldn't big pharma just LOVE to have natural supps out of the picture. You can't categorize all supplement companies into one big chunk and say that they cheat people out of their money and don't care about us? What would you rather take? Some synthetic drug that was created in a lab? Or a natural herb. I'd take a natural remedy ANYDAY. I have a great idea, why don't people do their research before ingesting a supplement. Go read a book, search good sources on the intenret, read health journals and magazines. I wouldn't take a supplement without HEAVILY researching it for the pros AND cons!

Edited by Polska Laska

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Okay, F*CK this crazy ass law. Wouldn't big pharma just LOVE to have natural supps out of the picture. You can't categorize all supplement companies into one big chunk and say that they cheat people out of their money and don't care about us? What would you rather take? Some synthetic drug that was created in a lab? Or a natural herb. I'd take a natural remedy ANYDAY. I have a great idea, why don't people do their research before ingesting a supplement. Go read a book, search good sources on the intenret, read health journals and magazines. I wouldn't take a supplement without HEAVILY researching it for the pros AND cons!

The picture you paint here is completely unrealistic and not factually accurate. The law isn't some crusade to "control" the supplement industry in order for big pharma companies to be able to make more profits. There is no conspiracy here.

Currently regulation of supplements lies with the states, and every state has different laws. Utah, in particular, has almost no regulation over the supplement industry. I could literally move to Utah, sell rice flower in pills for 100 bucks a bottle, and claim it did whatever I felt like claiming it did, as long as I marketed the pills as a dietary supplement. On top of that you can hide the exact ingredients in your supplement by labeling the ingredients as a "proprietary blend", and thus eliminate the need to pass on that vital info to consumers.

Pharmaceutical companies have to spend billions of dollars on drug research to prove that its safe for the public. Supplement companies by and large don't do any of this testing on their products, and at best may refer to some medical literature to prove that their supplements are indeed safe.

At a very minimum I think supplement companies should be required to list the ingredients on the bottle, and the products should have to go through some kind of approval process, even if it is just registering the ingredients in the bottle with the FDA.

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Okay, F*CK this crazy ass law. Wouldn't big pharma just LOVE to have natural supps out of the picture. You can't categorize all supplement companies into one big chunk and say that they cheat people out of their money and don't care about us? What would you rather take? Some synthetic drug that was created in a lab? Or a natural herb. I'd take a natural remedy ANYDAY. I have a great idea, why don't people do their research before ingesting a supplement. Go read a book, search good sources on the intenret, read health journals and magazines. I wouldn't take a supplement without HEAVILY researching it for the pros AND cons!

The picture you paint here is completely unrealistic and not factually accurate. The law isn't some crusade to "control" the supplement industry in order for big pharma companies to be able to make more profits. There is no conspiracy here.

Currently regulation of supplements lies with the states, and every state has different laws. Utah, in particular, has almost no regulation over the supplement industry. I could literally move to Utah, sell rice flower in pills for 100 bucks a bottle, and claim it did whatever I felt like claiming it did, as long as I marketed the pills as a dietary supplement. On top of that you can hide the exact ingredients in your supplement by labeling the ingredients as a "proprietary blend", and thus eliminate the need to pass on that vital info to consumers.

Pharmaceutical companies have to spend billions of dollars on drug research to prove that its safe for the public. Supplement companies by and large don't do any of this testing on their products, and at best may refer to some medical literature to prove that their supplements are indeed safe.

At a very minimum I think supplement companies should be required to list the ingredients on the bottle, and the products should have to go through some kind of approval process, even if it is just registering the ingredients in the bottle with the FDA.

I agree with everything you said, but the bolded parts especially. You wrote out what i was too lazy to say.

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Okay, F*CK this crazy ass law. Wouldn't big pharma just LOVE to have natural supps out of the picture. You can't categorize all supplement companies into one big chunk and say that they cheat people out of their money and don't care about us? What would you rather take? Some synthetic drug that was created in a lab? Or a natural herb. I'd take a natural remedy ANYDAY. I have a great idea, why don't people do their research before ingesting a supplement. Go read a book, search good sources on the intenret, read health journals and magazines. I wouldn't take a supplement without HEAVILY researching it for the pros AND cons!

The problem with that is: One, there aren't always credible and reliable sources or studies regarding a supplement. Two, there is no REAL way to be sure what is in the pill, because there's no regulation. They can say whatever they want. :rolleyes:

I demand to know what I am putting into my body.

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I have no idea what supplements people are purchasing but if they are sold in a reputable grocery/health food store, they are labeled. The only catch is the "proprietary blend" which will list the ingredients but not give us a specific amount for each ingredient, instead you get a total amount.

If CODEX were to become apart of the U.S. regulatory system, you could not take 100mg of Vitamin C at any frequency you choose because you are only limited to a certain number of pills per bottle. IF these fall under a prescription, you will run out of your prescription within a matter of days if you are taking 1000mg - 3000mg or more a day of Vitamin C. Not to mention the high level of cost either method will impose on the consumer. :naughty:

Sadly, it ain't over....

Ever hear of S. 510? Well, it's McCain's Food Safety bill (most bills may have some good intentions, but there's also the bad). Apparently, his focus will go back to this bill which has been stalled for a few months now. I haven't been able find this letter that is mentioned, but apparently, they are going to combine the Food Safety bill so that it includes parts of the DSSA:

McCain/Dorgan Anti-DSHEA bill dies… or does it?

Dietary Supplements, Clean Foods Next Victims of Fake "Safety" Bills

(you can sign the above petition if you like)

One more thing, I had a customer come up asking for a specific form of vitamin B6, Pyridoxamine. We looked at all the bottles on shelves and among the three main forms of B6 in nature, pyridoxamine was not one of them on our shelves. I was disheartened so I hopped on the Internet to see if any of the brands we carry offer this supplement. Sadly, what I found out is that since 2009 there has been an attempt to ban this supplement or the FDA has become successful in banning this product (only see one supplier).

I know we don't want to believe that this is about profit and control, but I am finding it hard to understand why the FDA would want to ban Pyridoxamine, when the FDA knows that it has powerful health benefits (breaks down AGEs, prevents diabetic neuropathy, etc). Reason...a drug company wanted to patent it and...because they realized it was a supplement being sold for less in stores, they had to devise a way to change that....

Currently LEF is the only company I've been able to find online that is selling this (through various retailers), until their supply runs out, and below is their write up about this:

FDA Seeks to Ban Pyridoxamine (July 2009)

(Stores are carrying the coenzymated form of B6, P5P, which has similar benefits)

Shame on You, FDA: Pyridoxamine and Health Freedom… and Truth!

(The above article also covers foods that have been under attack by the FDA)

All the best,

SJ

Edited by SweetJade1980

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I have no idea what supplements people are purchasing but if they are sold in a reputable grocery/health food store, they are labeled. The only catch is the "proprietary blend" which will list the ingredients but not give us a specific amount.

If CODEX were to become apart of the U.S. regulatory system, you could not take 100mg of Vitamin C at any frequency you choose because you are only limited to a certain number of pills per bottle. IF these fall under a prescription, you will run out of your prescription within a matter of days if you are taking 1000mg - 3000mg or more a day of Vitamin C. Not to mention the high level of cost either method will impose on the consumer. :naughty:

Sadly, it ain't over....

Ever hear of S. 510? Well, it's McCain's Food Safety bill (most bills may have some good intentions, but there's also the bad). Apparently, his focus will go back to this bill which has been stalled for a few months now. I haven't been able find this letter that is mentioned, but apparently, they are going to combine the Food Safety bill so that it includes parts of the DSSA:

McCain/Dorgan Anti-DSHEA bill dies… or does it?

Dietary Supplements, Clean Foods Next Victims of Fake "Safety" Bills

(you can sign the above petition if you like)

One more thing, I had a customer come up asking for a specific form of vitamin B6, Pyridoxamine. We looked at all the bottles on shelves and among the three main forms of B6 in nature, pyridoxamine was not one of them on our shelves. I was disheartened so I hopped on the Internet to see if any of the brands we carry offer this supplement. Sadly, what I found out is that since 2009 there has been an attempt to ban this supplement or the FDA has become successful in banning this product (only see one supplier).

I know we don't want to believe that this is about profit and control, but I am finding it hard to understand why the FDA would want to ban Pyridoxamine, when the FDA knows that it has powerful health benefits (breaks down AGEs, prevents diabetic neuropathy, etc). Reason...a drug company wanted to patent it and...because they realized it was a supplement being sold for less in stores, they had to devise a way to change that....

Currently LEF is the only company I've been able to find online that is selling this (through various retailers), until their supply runs out, and below is their write up about this:

FDA Seeks to Ban Pyridoxamine (July 2009)

(Stores are carrying the coenzymated form of B6, P5P, which has similar benefits)

Shame on You, FDA: Pyridoxamine and Health Freedom… and Truth!

(The above article also covers foods that have been under attack by the FDA)

All the best,

SJ

See, you completely ignore the most important part of the bill and instead post a bunch of conspiracy nonsense and other b.s. about how we will no longer be able to take the doses we want to.

You dismiss the whole proprietary blend thing as unimportant, when in face it is a big problem. As I said, I can sell ANYTHING I want to and claim it does ANYTHING I want it to as long as I sell it as a dietary supplement. Furthermore I wouldn't have to tell anyone what is in the product as long as I hit it behind the "proprietary blend" label. Maybe you have full faith that Whole Foods is some kind of altruist and would never sell you anything with a shady label or poor science too support the efficacy of the supplement. After all, they aren't one of the "evil" corporations that only care about money and profits? Oh wait, they are.

Also a proprietary blend doesn't have to list the ingredients or the amounts of the ingredients. A normal product label doesn't even have to list the amount of the ingredients, they just list them in order from highest to lowest concentration.

You may do some research on supplements before taking them, but I know plenty of people who don't do any research and will take whatever they find if they think it will help them. They are the ones who really get screwed by proprietary blend labeling.

Edited by Pimpstick

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So all those supplements found to have toxins like lead or mercury leaked into them would be under more strict observation? Sounds good to me.

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Okay, F*CK this crazy ass law. Wouldn't big pharma just LOVE to have natural supps out of the picture. You can't categorize all supplement companies into one big chunk and say that they cheat people out of their money and don't care about us? What would you rather take? Some synthetic drug that was created in a lab? Or a natural herb. I'd take a natural remedy ANYDAY. I have a great idea, why don't people do their research before ingesting a supplement. Go read a book, search good sources on the intenret, read health journals and magazines. I wouldn't take a supplement without HEAVILY researching it for the pros AND cons!

The problem with that is: One, there aren't always credible and reliable sources or studies regarding a supplement. Two, there is no REAL way to be sure what is in the pill, because there's no regulation. They can say whatever they want. :rolleyes:

I demand to know what I am putting into my body.

I'm with you on this. The supplement industry is making a killing off of people's ignorance. Just because "studies suggest..." doesn't always mean they'll work for that condition.

I, for one, think that there's absolutely nothing wrong in forcing them to label exactly everything in their supplements because frankly, I want to know what the hell I'm putting into myself. The only thing I can say I disagree with is having no phase in period - allowing companies time to actually print new labels and distribute them would only be fair.

And allergies are not a minor thing to consider in "natural flavorings" and such. A lot of people can die from allergic reactions. That's like saying their lives aren't as important because they're a small base of people - like they don't deserve some sort of protection - not to mention people who may not even KNOW they have an allergy until they take some supplements that unknowingly contain something that triggers a reaction.

I sort of feel that if they're trying so hard to fight this, it's because they have something to hide. If I was a brownie maker and some officials came to me and wanted me to disclose every single thing I put into them, I have nothing to hide, so I wouldn't really object - even if it irritated me because it'd consume a little of my time and perhaps my money. Now, if I was lacing my brownies with pot or something, I may try to prolong or fight it out so I don't get caught adding in things that I'm not reporting.

That, and there are a lot of studies that do sort of indicate that vitamins and supplements may not contain the entire amount that they're claiming they do. I remember reading a lot about that when I was still trying to take vitamins - before I realized it's actually a hell of a lot easier and better to just get it from food.

As it's already been said, the supplement industry has no more heart and concern for you than the pharmaceutical industry. In the end, they all just want your money. At least this way, you'll know what's in that supplement your interested in before you fork over your hard earned cash.

Edited by gMARIAs

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Ahh, OK...I understand the concern....I am not dismissing anything. I mentioned the points that I thought were important (i.e. natural flavorings, proprietary blends), but those points alone are not a reason to pass a bill that would alter other benefits that supplements provide us. You don't approve a bill if there is fault with it. Instead, you adjust the proposed bill so that your concerns are met, but they don't cause harm to the industry and most importantly...the consumer.

As it is now, you cannot saying anything about a supplement. You cannot make medical or disease claims, even if it they were true, or the FDA will crack down on you. It is already in effect and the FDA has done so to both supplement manufacturers (New Chapter, Garden of Life) and food manufacturers (General Mills, Dannon). Not because the products don't contain the ingredients listed that would be beneficial for a health condition, but because it would then be considered a drug...

I do not believe in conspiracy theories. I believe that knowledge is power and the more we as consumers know, the more informed we are, the better we can be at effecting change. So write, better yet call, your senators and tell them what you likeabout the bill and what you do not.

Again, there is currently regulation to support everything that the DSSA (and now possibly a revised S.510) was trying to accomplish, minus the nasty stuff. From all the manufacturers that I have trained with (just like pharmaceutical companies do trainings)...there is documentation:

  • Some don't actually just base their formulations off of studies, but actuallly conduct their own studies on the product lines.

  • Others actually will test the effectiveness of their formulations for several years before they release it into the public.

  • Thanks to technology, there are those that do guarantee potency of a product at expiration date (applies more so to probiotics).

  • Whether the raw materials are coming from the U.S., China, Canada, New Zealand or Norway, they also incorporate rigourous 3rd party standards for testing the safety and purity of the products.

  • Amazingly some companies will opt to not buy raw materials from China (sometimes they are the only producer) if they can get it elsewhere. The benefit may be less lead in the materials, which costs more, but at least that company knows they are selling a purer product to the consumer.

  • They maintain lot numbers so that if there is a problem, they can go back and test that lot to see if that lot indeed was faulty.

  • All supplement manufacturers are required to be apart of the Good Manufacturing Practices regulation, so quality standards will be in place for all.

I have no idea what Whole Foods standards are for selling supplements, but I know that Sunflower Markets and Natural Grocers by Vitamin Cottage, go through several panels and wait many months or even years before we (natural grocers) will approve a product for sale on our shelves. This may disappoint some consumers, but it's because we want to insure the quality and integrity of the products we sell. If a company were to change their forumalutions (and they do so without telling us), we willl pull it from our shelves if it contains an additive or an ingredient we do not sell.

Again, everything that I hear frustration about in this thread is already being regulated or can be. The FDA just needs the manpower and resources (shutting down labs does not do anyone good) to do their job, not just in the food industry, but also in the supplement industry. So perhaps we should also write our congressmen about that. Below are regulations currently in place:

  • The Dietary Supplement Health and Education Act of 1994 (DSHEA)

    DSHEA Act and labeling requirements

  • Dietary Supplement and Non-Prescription Drug Consumer Protection Act, S. 3546, 2006 (“the SAER billâ€) The SAER Bill

  • Good Manufacturing Practice Regulations, 2007 (GMP, cGMP) - There are supplement manufacturers that have followed these practices for over 10 years prior to the FDAs final ruling. http://www.cgmp.com

  • United States Pharmacopeia (USP) Verificaiton - Voluntary participation (but it has been used to test ingredients in China since 2007) USP Verifed - see list of companies participating

All the best,

SJ

Edited by SweetJade1980

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See, you completely ignore the most important part of the bill and instead post a bunch of conspiracy nonsense and other b.s. about how we will no longer be able to take the doses we want to.

You dismiss the whole proprietary blend thing as unimportant, when in face it is a big problem. As I said, I can sell ANYTHING I want to and claim it does ANYTHING I want it to as long as I sell it as a dietary supplement. Furthermore I wouldn't have to tell anyone what is in the product as long as I hit it behind the "proprietary blend" label. Maybe you have full faith that Whole Foods is some kind of altruist and would never sell you anything with a shady label or poor science too support the efficacy of the supplement. After all, they aren't one of the "evil" corporations that only care about money and profits? Oh wait, they are.

Also a proprietary blend doesn't have to list the ingredients or the amounts of the ingredients. A normal product label doesn't even have to list the amount of the ingredients, they just list them in order from highest to lowest concentration.

You may do some research on supplements before taking them, but I know plenty of people who don't do any research and will take whatever they find if they think it will help them. They are the ones who really get screwed by proprietary blend labeling.

Edited by SweetJade1980

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