07.31.20
Proposed legislation in the state legislative branches of Massachusetts and New York seek to ban the sale of dietary supplements formulated for weight loss and muscle building to minors. While no bill of this kind has passed in a state government, they are not unprecedented – Massachusetts legislators have previously reviewed and pulled similar legislation, and, as before, the dietary supplement industry opposes this type of restriction.
Yesterday, an amendment to a telehealth bill in Massachusetts was withdrawn by Rep. Kay Kahn in addition to the Joint Committee on Public Health which would have banned certain supplements in this category from sale to minors. While the add-on was pulled, she and 21 co-sponsors still support a standalone bill, H.4783, which lists a number of product classifications that would fall under the proposed age restriction. The bill is currently being reviewed by the State Assembly’s Joint Committee on Health Care Financing, and appears to be slated for a vote within the year.
“’Over-the-Counter Diet Pills’ may include, but are not limited to, thermogens, which are substances that produce heat in the body and promote more calorie burning, lipotropics, which are compounds that help break down fat during body metabolism, hormones, including hormone modulators and hormone mimetics, appetite suppressants, or ingredients deemed adulterated under [section 342 of the Food, Drug, and Cosmetic Act].”
The bill would require retail establishments to conduct ID checks for age verification purposes prior to the sale of dietary supplements for weight loss or muscle building. Additionally, clear signage provided by the department of health would communicate adverse side effects.
“Retail establishments shall conspicuously post at each purchase counter a notice developed and provided by the department of public health clearly communicating that certain over-the-counter diet pills, or dietary supplements for weight loss or muscle building are known to cause gastrointestinal impairment, tachycardia, hypertension, myocardial infarction, stroke, severe liver injury sometimes requiring transplant or leading to death, organ failure, other serious injury, and death,” the legislation reads.
Which supplements would fall under the purview of “weight loss and muscle building” products would be determined by each state’s public health department.
The New York State bill proposes similar bans on thermogens, lipotropics, hormone mimetics, appetite suppressants, and ingredients deemed adulterated. It also increases the state penalties for those found guilty of selling products containing ephedrine alkaloids, stimulants which were officially banned by FDA in 2004.
Each of these bills would require “weight loss and muscle building” supplements to be placed under lock-and-key, accessible only by a store manager.
Studies on teenage supplement usage of weight loss and muscle building supplements is varied. A survey conducted by the organization Monitoring the Future found that one in six male teenagers takes a creatine supplement. Additionally, the authors of this study were concerned by a small overlap between creatine use and steroid/androstenedione usage, though the teen use of these two drugs has been on a steady decline since 2001, in contrast to increased creatine use.
Another study on supplement usage found that, in 1,633 university students, there was a correlation between ergogenic supplement usage and disordered eating, concluding that doctors should screen for disordered eating behaviors in young adults who use ergogenic supplements. The authors did not attribute the cause of disordered eating to supplement usage, but viewed supplements as a potential marker for these issues.
While creatine has a strong safety profile in short- and possibly long-term studies of use in adults at proper dosages, it has not been studied sufficiently in teenagers for adverse events associated with long-term use. A review on the literature that does exist on teen creatine use, most of which evaluated its potential to mitigate inborn metabolic issues or neurological diseases, concludes that, so far, “creatine use in adolescent athletes appears to be well-tolerated with no reported adverse events and, second, that creatine use in this population can operate in an ergogenic fashion.” However, more research is needed, the authors wrote.
In the dietary supplements world, most thermogenic supplements’ primary active ingredient is caffeine, a green tea extract called L-Theanine, and a number of other herbal extracts, though, the thermogenic supplements market in the past has been marred by bad actors adulterating products with illegal stimulants, such as ephedrine alkaloids.
Industry: Good Intent, Wrong Target
Daniel Fabricant, PhD, president and CEO of the Natural Products Association, said that he was pleased to see that the telehealth bill amendment in Massachusetts was withdrawn, noting, however, that it was a small victory for those in opposition to this legislation.
“Nutritional supplements are simply natural ingredients found in foods, and restricting access to them is unfair to Massachusetts consumers, hurts responsible retailers, and drains the state budget through lost sales taxes. Nobody wins,” Fabricant said.
NPA filed a Freedom of Information Act request with the U.S. Food and Drug Administration to determined if a significant association existed between eating disorders and dietary supplements, and reportedly found no adverse events reporting associated with dietary supplements and eating disorders.
He pointed out that thermogenic ingredients can be found at comparable levels to supplements in many foods and beverages that have never been scrutinized in the same way, such as caffeine in coffee, or catechins found in green tea and beans.
Additionally, lipotropic ingredients are found in plenty of recommended meats and seafoods at comparable levels, Fabricant said. While the organization and other trade associations have said they support regulatory means of removing harmful, adulterated ingredients, and believe that the Food and Drug Administrations power to do so is vast, many of the ingredients targeted in these bills are found in abundance wihtin a typical diet.
NPA’s comments to the Massachusetts Joint Committee on Health Care Financing can be found here.
Furthermore, NPA and the Council For Responsible Nutrition have argued over the years that this bill and similar proposals have surfaced are not effective in harm reduction. Placing restrictions on the broad category of weight loss and muscle-building supplements is not an effective way to remove the harmful adulterant ingredients that have been discovered in many types of supplements, they said. Rather, they argue that legislation of this kind places an “undue burden” on those manufacturing and selling many ingredients that have a long history of safe use.
Yesterday, an amendment to a telehealth bill in Massachusetts was withdrawn by Rep. Kay Kahn in addition to the Joint Committee on Public Health which would have banned certain supplements in this category from sale to minors. While the add-on was pulled, she and 21 co-sponsors still support a standalone bill, H.4783, which lists a number of product classifications that would fall under the proposed age restriction. The bill is currently being reviewed by the State Assembly’s Joint Committee on Health Care Financing, and appears to be slated for a vote within the year.
“’Over-the-Counter Diet Pills’ may include, but are not limited to, thermogens, which are substances that produce heat in the body and promote more calorie burning, lipotropics, which are compounds that help break down fat during body metabolism, hormones, including hormone modulators and hormone mimetics, appetite suppressants, or ingredients deemed adulterated under [section 342 of the Food, Drug, and Cosmetic Act].”
The bill would require retail establishments to conduct ID checks for age verification purposes prior to the sale of dietary supplements for weight loss or muscle building. Additionally, clear signage provided by the department of health would communicate adverse side effects.
“Retail establishments shall conspicuously post at each purchase counter a notice developed and provided by the department of public health clearly communicating that certain over-the-counter diet pills, or dietary supplements for weight loss or muscle building are known to cause gastrointestinal impairment, tachycardia, hypertension, myocardial infarction, stroke, severe liver injury sometimes requiring transplant or leading to death, organ failure, other serious injury, and death,” the legislation reads.
Which supplements would fall under the purview of “weight loss and muscle building” products would be determined by each state’s public health department.
The New York State bill proposes similar bans on thermogens, lipotropics, hormone mimetics, appetite suppressants, and ingredients deemed adulterated. It also increases the state penalties for those found guilty of selling products containing ephedrine alkaloids, stimulants which were officially banned by FDA in 2004.
Each of these bills would require “weight loss and muscle building” supplements to be placed under lock-and-key, accessible only by a store manager.
Studies on teenage supplement usage of weight loss and muscle building supplements is varied. A survey conducted by the organization Monitoring the Future found that one in six male teenagers takes a creatine supplement. Additionally, the authors of this study were concerned by a small overlap between creatine use and steroid/androstenedione usage, though the teen use of these two drugs has been on a steady decline since 2001, in contrast to increased creatine use.
Another study on supplement usage found that, in 1,633 university students, there was a correlation between ergogenic supplement usage and disordered eating, concluding that doctors should screen for disordered eating behaviors in young adults who use ergogenic supplements. The authors did not attribute the cause of disordered eating to supplement usage, but viewed supplements as a potential marker for these issues.
While creatine has a strong safety profile in short- and possibly long-term studies of use in adults at proper dosages, it has not been studied sufficiently in teenagers for adverse events associated with long-term use. A review on the literature that does exist on teen creatine use, most of which evaluated its potential to mitigate inborn metabolic issues or neurological diseases, concludes that, so far, “creatine use in adolescent athletes appears to be well-tolerated with no reported adverse events and, second, that creatine use in this population can operate in an ergogenic fashion.” However, more research is needed, the authors wrote.
In the dietary supplements world, most thermogenic supplements’ primary active ingredient is caffeine, a green tea extract called L-Theanine, and a number of other herbal extracts, though, the thermogenic supplements market in the past has been marred by bad actors adulterating products with illegal stimulants, such as ephedrine alkaloids.
Industry: Good Intent, Wrong Target
Daniel Fabricant, PhD, president and CEO of the Natural Products Association, said that he was pleased to see that the telehealth bill amendment in Massachusetts was withdrawn, noting, however, that it was a small victory for those in opposition to this legislation.
“Nutritional supplements are simply natural ingredients found in foods, and restricting access to them is unfair to Massachusetts consumers, hurts responsible retailers, and drains the state budget through lost sales taxes. Nobody wins,” Fabricant said.
NPA filed a Freedom of Information Act request with the U.S. Food and Drug Administration to determined if a significant association existed between eating disorders and dietary supplements, and reportedly found no adverse events reporting associated with dietary supplements and eating disorders.
He pointed out that thermogenic ingredients can be found at comparable levels to supplements in many foods and beverages that have never been scrutinized in the same way, such as caffeine in coffee, or catechins found in green tea and beans.
Additionally, lipotropic ingredients are found in plenty of recommended meats and seafoods at comparable levels, Fabricant said. While the organization and other trade associations have said they support regulatory means of removing harmful, adulterated ingredients, and believe that the Food and Drug Administrations power to do so is vast, many of the ingredients targeted in these bills are found in abundance wihtin a typical diet.
NPA’s comments to the Massachusetts Joint Committee on Health Care Financing can be found here.
Furthermore, NPA and the Council For Responsible Nutrition have argued over the years that this bill and similar proposals have surfaced are not effective in harm reduction. Placing restrictions on the broad category of weight loss and muscle-building supplements is not an effective way to remove the harmful adulterant ingredients that have been discovered in many types of supplements, they said. Rather, they argue that legislation of this kind places an “undue burden” on those manufacturing and selling many ingredients that have a long history of safe use.
