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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
QUOTE
By James Gormley, Senior Policy Advisor, Citizens for Health
More Info @ The Gormley Files
1. No phase-in period or “effective date”. 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.
More Info @ The Gormley Files
1. No phase-in period or “effective date”. 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.
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SJ
